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Hepatic Venous Pressure Gradient Versus Endoscopic Ultrasound-Guided Portal Pressure Gradient - Comparative Analysis (HEPCA)

NCT07424963
Recruiting
Conditions Cirrhosis, Portal Hypertension, EUS, Non...
Phase NA
Enrollment 40
Locations 2 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-15
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Study Details Design, interventions, and primary outcomes

About This Study

The goal of this interventional trial is to compare in measuring of portal hypertension by HVPG and EUS-PPG in subject indicated to HVPG measurement. The primary question is whether EUS-PPG provides measurements really equivalent to HVPG in terms of gradient accuracy. Participants undergoing HVPG will first undergo the procedure while conscious, performed by the first operator. Immediately thereafter, HVPG will be repeated following the induction of anesthesia by a second operator blinded to the initial readings. Subsequently, EUS-PPG will be performed by an endoscopist, who will also be blinded to all previous pressure measurements.

Design

Study type: Interventional Phases: Allocation: Intervention model: Single Group Primary purpose: Diagnostic Masking/blinding: None

Interventions / Regimen

  • Procedure: Hepatic venous pressure gradient measurement — HVPG measurement is minimally invasive procedure that involves cannulation of the right internal jugular vein, followed by the insertion of a balloon-occlusion catheter into the right or middle hepatic vein to measure both free hepatic vein pressure and wedged hepatic vein pressure, enabling the calculation of HVPG. Additionally, this method allows for liver biopsy during the same session. HVPG is widely regarded as the gold standard for PPG measurement.
  • Procedure: Endoscopic ultrasound-guided portal pressure gradient measurement — Recent advancements in the field of digestive endoscopy have introduced an innovative alternative: endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement. This emerging technique shows promise for further improving the accessibility of portal hypertension assessment and also offers the possibility of liver biopsy in one session. EUS-PPG may have several advantages, including its minimally invasive nature, safety profile, high technical success rate, the possibility of a "one-stopshop" approach (combining EUS-PPG, liver biopsy, and endoscopic treatment of esophageal varices), absence of radiation exposure.

Primary Outcomes

  • Evaluation of the consistency between the HVPG and EUS-PPG (30 days after enrollment)
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Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-05-30
Completion: 2028-12-31
Eligibility
Age: 18 Years – 75 Years
Sex: ALL
Volunteers: false
Enrollment: 40 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Military University Hospital, Prague
Collaborators: Institute for Clinical and Experimental Medicine
Principal Investigators:
  • Petr Hříbek, MD, PhD (PRINCIPAL_INVESTIGATOR) - Military University Hospital, Prague
Contact Information
Study Contact:
Petr Hříbek, MD, PhD
+420973203065
petr.hribek@uvn.cz
Petr Urbánek, Prof.
petr.urbanek@uvn.cz
Petr Hříbek, MD, PhD
+420973203065
petr.hribek@uvn.cz
Military University Hospital Prague
Interventions
  • Procedure: Hepatic venous pressure gradient measurement — HVPG measurement is minimally invasive procedure that involves cannulation of the right internal jugular vein, followed by the insertion of a balloon-occlusion catheter into the right or middle hepatic vein to measure both free hepatic vein pressure and wedged hepatic vein pressure, enabling the calculation of HVPG. Additionally, this method allows for liver biopsy during the same session. HVPG is widely regarded as the gold standard for PPG measurement.
  • Procedure: Endoscopic ultrasound-guided portal pressure gradient measurement — Recent advancements in the field of digestive endoscopy have introduced an innovative alternative: endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement. This emerging technique shows promise for further improving the accessibility of portal hypertension assessment and also offers the possibility of liver biopsy in one session. EUS-PPG may have several advantages, including its minimally invasive nature, safety profile, high technical success rate, the possibility of a "one-stopshop" approach (combining EUS-PPG, liver biopsy, and endoscopic treatment of esophageal varices), absence of radiation exposure.
Study Locations (2 sites)
Military University Hospital Prague, Prague, Bohemia 16902 Czechia
IKEM, Prague, Czechia
Eligibility Criteria
Inclusion Criteria: * Age 18-75 years at the time of enrollment; signed informed consent * Clinical indication for HVPG measurement and/or transjugular liver biopsy for chronic advanced liver disease Exclusion Criteria: * Severe co-morbidities (e.g., advanced chronic heart failure, chronic renal insufficiency stage 4 and above, long-term poorly compensated diabetes mellitus with severe complications) * Pregnancy * Estimated patient non-compliance and/or not signing of the informed consent * Documented iodine contrast dye allergy * Presence of portal vein thrombosis or cavernomatous transformation of portal vein or hepatic vein obstruction * Ascites Grade 3 * Biliary obstruction * Anticoagulation or antiplatelet therapy, which cannot be discontinued * INR \> 1.5 and/or platelet count \< 50,000/µl * Hepatocellular carcinoma in the left lobe of the liver * Surgically altered upper gastrointestinal tract anatomy * State after transjugular intrahepatic portosystemic shunt * State after liver transplantation

Sotatercept in Pulmonary Arterial Hypertension

NCT07140484
Recruiting
Conditions Pulmonary Artery Hypertension
Phase PHASE4
Enrollment 27
Locations 1 sites
Compensation Compensation or reimbursement is mentioned in the public study record; confirm details with the study team.
Data Updated 2026-11-15
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Study Details Design, interventions, and primary outcomes

About This Study

The goal of this clinical trial is to determine whether sotatercept is effective in improving diffusing capacity in patients with pulmonary arterial hypertension. Participants will be asked to: * Take Sotatercept every 21 days (±3 days) * Each participant will be enrolled in the study for 29 Weeks * Visit the clinic 18 times * Have a physical exam * Perform assessments of lung function and exercise tests * Have an ultrasound of their heart * Have blood draws done at regular intervals The main objectives of the study are: Primary objective: To assess whether sotatercept will improve recruitment of diffusing membrane capacity (DM) with exercise. Secondary objective: To identify components of the diffusing capacity that respond to treatment with sotatercept in pulmonary arterial hypertension.

Design

Study type: Interventional Phases: Phase4 Allocation: Intervention model: Single Group Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: Sotatercept — 0.7mg/kg

Primary Outcomes

  • Lung diffusing capacity (6 weeks post starting treatment)
  • Lung diffusing capacity (23 weeks post starting treatment)
  • Diffusing membrane capacity (Dm) (6 weeks post starting treatment)
  • Diffusing membrane capacity (Dm) (23 weeks post starting treatment)
  • Pulmonary capillary blood volume (Vc) (6 weeks post starting treatment)
  • Pulmonary capillary blood volume (Vc) (23 weeks post starting treatment)
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Contact the study team directly or view the official listing
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Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Recruiting
Start Date: 2025-10-06
Completion: 2030-01-01
Eligibility
Age: 18 Years and older
Sex: ALL
Volunteers: false
Enrollment: 27 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Alberta
Collaborators: Merck Canada Inc., Alberta Health services
Principal Investigators:
  • Jason Weatherald, MD (PRINCIPAL_INVESTIGATOR) - University of Alberta
  • Michael Stickland, PhD (PRINCIPAL_INVESTIGATOR) - University of Alberta
Contact Information
Study Contact:
Desi Fuhr, MSc
7804921121
fuhr@ualberta.ca
Kostia Dmytriiev, MD
7804928027
kdmytrii@ualberta.ca
Desi Fuhr
7804921121
fuhr@ualberta.ca
Clinical Physiology Laboratory
Interventions
  • Drug: Sotatercept — 0.7mg/kg
Study Locations (1 sites)
Clinical Physiology Laboratory, Edmonton, Alberta T6G2R3 Canada
Eligibility Criteria
Eligible participants must meet all of the following inclusion criteria to be enrolled in the study: 1. Age ≥ 18 years. 2. Documented diagnostic right heart catheterization (RHC) at any time prior to screening confirming the diagnosis of PAH Group 1 in any of the following subtypes: * Idiopathic PAH * Heritable PAH * Drug/toxin-induced PAH * PAH associated with CTD * PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair. 3. Symptomatic PAH classified as WHO FC II or III. 4. On stable doses of ≥2 background PAH therapies for at least 60 days prior to screening; for infusion prostacyclins, dose adjustment within 10% of the optimal dose is allowed per medical practice. Patients on 1 background PAH therapy are eligible if there is documented intolerance or contraindication to use of the other 2 classes (e.g. liver enzyme elevation while taking an ERA). 5. Females of childbearing potential must: * Have a negative urine or serum pregnancy tests as verified by the investigator prior to starting study therapy. * If sexually active, have used, and agree to use highly effective contraception without interruption during the study (including dose interruptions), and for 16 weeks (112 days) after discontinuation of study treatment. * Refrain from breastfeeding a child or donating blood, eggs, or ovum for the duration of the study and for at least 16 weeks (112 days) after the last dose of study treatment. 6. Male participants must: * Agree to use a condom, defined as a male latex condom or nonlatex condom NOT made out of natural (animal) membrane (e.g., polyurethane), during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 16 weeks (112 days) following investigational product discontinuation, even if he has undergone a successful vasectomy. * Refrain from donating blood or sperm for the duration of the study and for 16 weeks (112 days) after the last dose of study treatment 7. Ability to adhere to study visit schedule and understand and comply with all protocol requirements. 8. Ability to understand and provide written informed consent. Exclusion Criteria 1. 1\. Diagnosis of pulmonary hypertension WHO Groups 2, 3, 4, or 5 2. Musculoskeletal limitation that precludes participation in cycle ergometry 3. Resting oxygen saturation \< 88%. (Note: patients on oxygen can be included in the study if they can maintain a resting saturation of ≥ 88 % after 3 minutes off oxygen). 4. Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH and PAH associated with portal hypertension, schistosomiasis-associated PAH and pulmonary veno-occlusive disease. 5. Hemoglobin (Hgb) at screening above the gender-specific upper limit of normal (ULN), per local laboratory test. 6. Baseline platelet count \< 50,000/mm3 (\< 50.0 × 109/L) in the enrollment period. 7. Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure \> 160 mmHg or sitting diastolic blood pressure \> 100 mmHg during a screening visit after a period of rest. 8. Baseline systolic blood pressure \< 90 mmHg at screening. 9. Pregnant or breastfeeding women. 10. Any of the following clinical laboratory values at the screening visit: * Estimated glomerular filtration rate (eGFR) \< 30 mL/min/m2 (as defined by the Modification of Diet in Renal Disease \[MDRD\] equation) * Serum alanine aminotransferase, aspartate aminotransferase, or total bilirubin levels \> 3 × ULN (bilirubin criterion waived if there is a documented history of Gilbert's syndrome). 11. Currently enrolled in or have completed any other investigational product study within 30 days for small-molecule drugs or within 5 half-lives for biologics prior to the date of signed informed consent. 12. History of full pneumonectomy. 13. Pulmonary function test (PFT) values of forced vital capacity (FVC) \< 60% predicted and/or FEV1/FVC \< lower limit of normal at the screening visit or within 6 months prior to the screening visit. 14. Smoking history of ≥ 20 pack-years or any tobacco smoking or vaping within the previous 3 months. 15. Body mass index ≥ 40 kg/m2. 16. Planned initiation of an exercise program for cardiopulmonary rehabilitation during the study (participants who are stable in the maintenance phase of a program and who will continue for the duration of the study are eligible). 17. Known history of portal hypertension or chronic liver disease, including hepatitis B and/or hepatitis C (with evidence of recent infection and/or active virus replication), defined as mild to severe hepatic impairment (Child-Pugh Class A-C). 18. History of restrictive, constrictive, or congestive cardiomyopathy. 19. History of atrial septostomy within 180 days prior to the screening visit. 20. Electrocardiogram (ECG) with Fridericia's corrected QT interval (QTcF) \> 500 ms during the Screening Period 21. Personal or family history of long QT syndrome (LQTS) or sudden cardiac death. 22. Left ventricular ejection fraction \< 45% on historical echocardiogram within 6 months prior to the screening visit. 23. Any symptomatic coronary disease events (prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain) within 6 months prior to the screening visit. Note: Anginal pain can be ignored as an exclusion criterion if coronary angiography shows no obstructions. 24. Cerebrovascular accident within 3 months prior to the Screening Visit. 25. Significant mitral or aortic valve dysfunction (greater than moderate mitral regurgitation or aortic regurgitation, or greater than mild mitral stenosis or aortic stenosis). 26. Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine, vasopressin) within 30 days prior to the screening visit. 27. Known hypersensitivity to sotatercept or to any ingredient in the formulation or component of the container.

Steroids-Based Screening for Primary Aldosteronism

NCT06941116
Recruiting
Conditions Primary Aldosteronism, Hypertension
Phase Not Applicable
Enrollment 406
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-15
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

This prospective, single-center observational study aims to evaluate whether a steroid-based screening method can more accurately identify Primary Aldosteronism (PA) in hypertensive patients who remain on their usual antihypertensive medications, compared with the conventional aldosterone-to-renin ratio (ARR). PA is a common, potentially curable subtype of secondary hypertension that carries increased cardiovascular risk when undiagnosed or untreated. However, current screening protocols recommend "medication washout" or switching to minimally interfering drugs, which may pose safety concerns and add complexity. In this study, approximately 406 participants (ages 18-75) with diagnosed hypertension and on at least one interfering antihypertensive drug (such as ACE inhibitors, ARBs, beta-blockers, diuretics, or calcium channel blockers) will be enrolled at the Department of Endocrinology, The First Affiliated Hospital of Chongqing Medical University. Each participant will undergo two rounds of blood sampling-first while continuing their usual antihypertensive regimen (the "on-medication" state) and second following a standardized washout/switch period (the "standard state"), if medically feasible. At both stages, levels of plasma aldosterone, renin, and a broad panel of adrenal steroid hormones will be measured by liquid chromatography-tandem mass spectrometry. By comparing diagnostic performance (e.g., sensitivity, specificity, and area under the receiver operating characteristic curve) of the steroid-based screening versus the ARR, the study seeks to determine whether steroid profiling improves accuracy under real-world treatment conditions. Findings may help refine PA screening strategies, reduce the need for extensive medication adjustments, and contribute to better clinical management of hypertension.

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Interventions / Regimen

  • Diagnostic Test: Steroid-Based Screening (LC-MS/MS) — This diagnostic intervention is a liquid chromatography-tandem mass spectrometry (LC-MS/MS)-based steroid profiling assay. It measures a panel of 18 adrenal steroid hormones (e.g., aldosterone, 18-hydroxycortisol, 18-oxocortisol, corticosterone) from plasma samples. In this study, it is used to screen for Primary Aldosteronism (PA) while patients remain on their usual antihypertensive medications. By comparing these steroid profiles against standard aldosterone-renin measurements, the method aims to reduce the need for medication washout and improve diagnostic accuracy for PA.

Primary Outcomes

  • Diagnostic Accuracy of Steroid-Based Screening vs. ARR for Primary Aldosteronism in Patients on Antihypertensive Medications (From baseline screening while on medication to completion of confirmatory testing, approximately 4-8 weeks.)
Interested in this trial?
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Study Contact:
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2025-04-15
Completion: 2026-12-30
Eligibility
Age: 18 Years – 75 Years
Sex: ALL
Volunteers: false
Enrollment: 406 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Qifu Li
Principal Investigators:
  • Qifu Li, MD, PhD, Chief Physician (PRINCIPAL_INVESTIGATOR) - First Affiliated Hospital of Chongqing Medical University
Contact Information
Study Contact:
Qifu Li, MD, PhD, Chief Physician
+8618696676815
liqifu@yeah.net
Shumin Yang, MD, PhD, Chief Physician
‭+8615523552235‬
443068494@qq.com
Yixin Zhang, MD
+8618716816738
zhangyixin5201998@163.com
The First Affiliated Hospital of Chongqing Medical University
Interventions
  • Diagnostic Test: Steroid-Based Screening (LC-MS/MS) — This diagnostic intervention is a liquid chromatography-tandem mass spectrometry (LC-MS/MS)-based steroid profiling assay. It measures a panel of 18 adrenal steroid hormones (e.g., aldosterone, 18-hydroxycortisol, 18-oxocortisol, corticosterone) from plasma samples. In this study, it is used to screen for Primary Aldosteronism (PA) while patients remain on their usual antihypertensive medications. By comparing these steroid profiles against standard aldosterone-renin measurements, the method aims to reduce the need for medication washout and improve diagnostic accuracy for PA.
Study Locations (1 sites)
The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality 4000016 China
Eligibility Criteria
Inclusion Criteria: 1. Aged 18-75 years, with no sex restriction. 2. Diagnosed with hypertension, defined as a systolic blood pressure ≥140 mmHg and/or a diastolic blood pressure ≥90 mmHg measured on at least two different days. 3. Currently receiving at least one antihypertensive medication that interferes with aldosterone or renin (ACEI/ARB, β-blockers, dihydropyridine CCBs, or diuretics including MRA) for ≥4 consecutive weeks. 4. Fully informed about the study procedures and risks, and willing to participate by signing a written informed consent form. Exclusion Criteria: 1. Confirmed secondary hypertension of other etiologies (e.g., renovascular hypertension, renal artery stenosis, reninoma, pheochromocytoma, Cushing's syndrome, Liddle syndrome), excluding obstructive sleep apnea. 2. Severe cardiac, hepatic, or renal impairment or serious infections, including but not limited to New York Heart Association (NYHA) Class III-IV heart failure, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels exceeding 2.5 times the upper limit of normal, estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m², or severe infections (e.g., diabetic foot, sepsis, pneumonia, refractory infections). 3. History of major cardiovascular or cerebrovascular events within the past 3 months. 4. Pregnant or breastfeeding women. 5. Currently using medications (other than the listed antihypertensives) that may affect aldosterone or renin secretion, including but not limited to sex hormones (e.g., oral contraceptives, estrogen replacement therapy), glucocorticoids (e.g., prednisone, dexamethasone), nonsteroidal anti-inflammatory drugs (NSAIDs, e.g., aspirin, ibuprofen), or antipsychotics (e.g., chlorpromazine, olanzapine). 6. Individuals lacking or having restricted capacity for independent decision-making or action. 7. History of psychiatric disorders. 8. Poor compliance likely to compromise study completion.

QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Triple-Negative Breast Cancer

NCT07342283
Recruiting
Conditions Triple Negative Breast Cancer (TNBC)
Phase PHASE2
Enrollment 30
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-15
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

This is a single-center, single-arm, prospective study enrolling 30 patients with stage II-III triple-negative breast cancer. The neoadjuvant regimen consists of QL1706 combined with carboplatin plus albumin-bound paclitaxel (21-day cycles for 4 cycles) followed by QL1706 combined with doxorubicin/epirubicin plus cyclophosphamide (21-day cycles for 4 cycles). The treatment observation period is 1 year, and the primary endpoint is the pathological complete response rate.

Design

Study type: Interventional Phases: Phase2 Allocation: Intervention model: Single Group Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: Immunotherapy combined with chemotherapy — Albumin-bound paclitaxel: 125 mg/m², day 1 and day 8, 21-day cycle; Carboplatin: AUC = 5, day 1 or AUC = 2-3, day 1 and day 8, 21-day cycle; QL1706: 5 mg/kg, day 1, 21-day cycle; Epirubicin: 90-100 mg/m², day 1, 21-day cycle; or Doxorubicin: 50 mg/m², day 1, 21-day cycle; Cyclophosphamide: 600 mg/m², day 1, 21-day cycle.

Primary Outcomes

  • Pathologic complete response (pCR) rates (Up to approximately 9 months)
Interested in this trial?
Contact the study team directly or view the official listing
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Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2026-02-25
Completion: 2028-12-25
Eligibility
Age: 18 Years and older
Sex: ALL
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Affiliated Hospital of Nantong University
Contact Information
Study Contact:
Liu Fan
86+18912250939
lflove2009@126.com
0513 8505 2222
Affiliated Hospital of Nantong University
Interventions
  • Drug: Immunotherapy combined with chemotherapy — Albumin-bound paclitaxel: 125 mg/m², day 1 and day 8, 21-day cycle; Carboplatin: AUC = 5, day 1 or AUC = 2-3, day 1 and day 8, 21-day cycle; QL1706: 5 mg/kg, day 1, 21-day cycle; Epirubicin: 90-100 mg/m², day 1, 21-day cycle; or Doxorubicin: 50 mg/m², day 1, 21-day cycle; Cyclophosphamide: 600 mg/m², day 1, 21-day cycle.
Study Locations (1 sites)
Affiliated Hospital of Nantong University, Nantong, Jiangsu China
Eligibility Criteria
Inclusion Criteria: 1. Histologically or cytologically confirmed newly diagnosed ER-/HER2- breast cancer. ER and PR with Allred score \<3 or \<1% positively stained cells in tumor infiltrating components. HER2 negativity defined as 0 or 1+ by FISH or IHC staining per NCCN guidelines; 2. Clinical stage II or III breast cancer eligible for neoadjuvant chemotherapy (per AJCC 8th edition: at least T2 any N M0, or any T if N+), with treatment goal of complete surgical resection following neoadjuvant therapy; 3. Tumor size ≥2 cm by clinical or imaging assessment per WHO criteria. Patients with histologically confirmed or clinically palpable lymph nodes are eligible regardless of tumor size; 4. Treatment-naïve subjects; 5. Age ≥18 years, both genders eligible; 6. ECOG performance status 0-1; 7. Adequate bone marrow, cardiac, and organ function; 8. Women of childbearing potential must have a negative pregnancy test (serum or urine HCG) within 30 days prior to study enrollment and must practice effective contraception during the study; 9. Ability to comprehend and provide written informed consent. Exclusion Criteria: 1. History of invasive malignancies within 5 years prior to signing the informed consent form, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or carcinoma in situ of the cervix; 2. Subjects who have received chemotherapy, immunotherapy, targeted therapy, or radiotherapy within the past 12 months; 3. Stage IV metastatic breast cancer; 4. Administration of a vaccine within 30 days before the first dose of the study treatment; 5. Subjects with severe systemic diseases; 6. Subjects with active infections (including but not limited to HIV, hepatitis B or C, tuberculosis); 7. Severe cardiovascular diseases, such as: history of myocardial infarction, acute coronary syndrome, or coronary angioplasty/stenting/bypass grafting within the past 6 months; or congestive heart failure (CHF) of New York Heart Association (NYHA) class II-IV, or history of CHF NYHA class III or IV; 8. Lactating women should discontinue breastfeeding during the study; 9. Subjects with known allergies to the study drug or any of its excipients; 10. Any other condition deemed inappropriate for participation in the study by the investigator. \-

A Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer

NCT05911958
Recruiting
Conditions HER2 Low Breast Carcinoma
Phase PHASE2
Enrollment 66
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-15
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

HR-positive breast cancers accounts for about 50% to 60% of all breast cancer patients. Neoadjuvant Chemotherapy is the core treatment mode for this type of breast cancer, and endocrine therapy can be used in some low-risk patients. However, the pathological complete response (pCR) rate obtained is low. HER2 is an important prognostic indicator and therapeutic target for breast cancer. Nearly 60% of HR-positive breast cancers have low expression of HER2, and antibody-drug conjugates (ADC) targeting HER2 may achieve better efficacy in this subtype.

Design

Study type: Interventional Phases: Phase2 Allocation: Intervention model: Single Group Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: SHR-A1811 for injection — SHR-A1811 for injection

Primary Outcomes

  • Objective Response Rate (ORR) Tumours (RECIST) v1.1 (During 24 weeks of the neoadjuvant treatment)
Interested in this trial?
Contact the study team directly or view the official listing
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Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2023-07-05
Completion: 2029-05-31
Eligibility
Age: 18 Years – 70 Years
Sex: FEMALE
Volunteers: false
Enrollment: 66 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Henan Cancer Hospital
Principal Investigators:
  • Zhenzhen Liu, PhD (PRINCIPAL_INVESTIGATOR) - Henan Cancer Hospital
Contact Information
Study Contact:
Zhenzhen Liu, Professor
+86-13603862755
liuzhenzhen73@126.com
Jiujun Zhu, PhD
+86-13676962766
bigapple0601@126.com
Jiao DeChuang
13598004327
jiaodechuang1982@163.com
Henan Cancer Hospital
Interventions
  • Drug: SHR-A1811 for injection — SHR-A1811 for injection
Study Locations (1 sites)
Henan Cancer Hospital, Zhengzhou, Henan 450008 China
Eligibility Criteria
Inclusion Criteria: 1. Patients aged 18 to 70 years old (inclusive); 2. Treatment-naive patients with clinically confirmed T2-T3, any nodal status and M0; 3. HR-positive, HER2 low expression, the expression of Ki-67 exceed 14% invasive breast cancer confirmed by histology or cytology; 4. ECOG performance status of 0-1; 5. Normal organ and bone marrow function; 6. Patients of childbearing age must consent to use highly effective contraception for 7 months from the start of study screening until the last study medication and agree not to breastfeeding; 7. Patients voluntarily joined the study and signed informed consent; Exclusion Criteria: 1. Patients have evidence of metastatic breast cancer, or inflammatory breast cancer; 2. Patients previously received antineoplastic therapy or radiotherapy for any malignancy, excluding cured malignancies such as cervical carcinoma in situ, basal cell carcinoma, or squamous carcinoma; 3. Patients received any other anti-tumor therapy at the same time, including endocrine therapy, bisphosphonates or immunotherapy; 4. Patients have major surgical procedures unrelated to breast cancer within 4 weeks before the first medication, or not fully recovered from surgical procedures; 5. Clinically significant pulmonary or cardiovascular disease; 6. Failure to swallow, chronic diarrhea, intestinal obstruction, or presence of other factors affecting drug administration and absorption; 7. Known to be allergic to any study drug or any of its excipients; 8. History of immunodeficiency, including HIV-positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation; 9. Pregnant and lactating women; 10. Patients with serious concomitant diseases or other comorbidities that will interfere with the planned treatment, or any other condition that is not suitable for participation assessed by investigator.

Improving Care for Rural Patients With Solid Tumors

NCT04916990
Recruiting
Conditions Lung Cancer, Head and Neck Cancer, Thyro...
Phase NA
Enrollment 320
Locations 14 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-15
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

This study will assess if the CARES (Cancer Advocacy, Resources, Education and Support) intervention improves time to start of treatment after diagnosis and time to treatment completion for solid tumors (ex: lung, head, neck, thyroid, cervical, breast, bladder, colon, and rectal cancers) in rural patients.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Health Services Research Masking/blinding: None

Interventions / Regimen

  • Behavioral: CARES Intervention — Nurse navigators and masters levels counselors will meet with participants up to 10 times each (10 navigation and 10 counseling) over a 6 month period. The number of sessions will be determined by the length of the patient's treatment. The timing of each session will be guided by a regular assessment to reduce the time from diagnosis to initiation of treatment and the time between subsequent treatments. Sessions will occur at key transition points during treatment to target the factors associated with treatment delays, reduced Quality of Care and poor Patient Reported Outcomes

Primary Outcomes

  • Time to care (From study start to study end (6 months))
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2022-09-01
Completion: 2027-06-30
Eligibility
Age: 18 Years – 99 Years
Sex: ALL
Volunteers: false
Enrollment: 320 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Colorado, Denver
Collaborators: National Cancer Institute (NCI)
Principal Investigators:
  • Evelinn Borrayo, PhD (PRINCIPAL_INVESTIGATOR) - University of Colorado, Denver
Contact Information
Study Contact:
Jennifer V Gonzalez, MS
3037246278
jennifer.villalobosgonzalez@cuanschutz.edu
Tatiana Gerena, MPH
303-724-5439
tatiana.gerena@cuanschutz.edu
Jennifer V Gonzalez
cc_timelinessstudy@cuanschutz.edu
University of Colorado Hospital
Interventions
  • Behavioral: CARES Intervention — Nurse navigators and masters levels counselors will meet with participants up to 10 times each (10 navigation and 10 counseling) over a 6 month period. The number of sessions will be determined by the length of the patient's treatment. The timing of each session will be guided by a regular assessment to reduce the time from diagnosis to initiation of treatment and the time between subsequent treatments. Sessions will occur at key transition points during treatment to target the factors associated with treatment delays, reduced Quality of Care and poor Patient Reported Outcomes
Study Locations (14 sites)
University of Colorado Hospital, Aurora, Colorado 80045 United States
Memorial Hospital Central, Colorado Springs, Colorado 80909 United States
Memorial Hospital North, Colorado Springs, Colorado 80920 United States
Poudre Valley Hospital, Fort Collins, Colorado 80524 United States
SCL- St. Mary's Medical Center, Grand Junction, Colorado 81501 United States
VA Western Colorado Health Care System, Grand Junction, Colorado 81501 United States
Greeley Campus, Greeley, Colorado 80634 United States
Highlands Ranch Hospital, Highlands Ranch, Colorado 80129 United States
Medical Center of the Rockies, Loveland, Colorado 80538 United States
San Juan Cancer Center, Montrose, Colorado 81401 United States
Eligibility Criteria
Inclusion Criteria Assessed During Screening: 1. Provision to sign and date the consent form. 2. Stated willingness to comply with all study procedures and be available for the duration of the study. 3. Male and female adults over 18 years old 4. English or Spanish speaking 5. Receives cancer treatment at UCH- Aurora, UCH-Highlands Ranch, UCHealth North, UCHealth South- UCHealth Memorial Hospital, UCHealth Parkview Hospital, San Juan Cancer Center, RMCC-Pueblo, SCL-St. Mary's, or Parkview Medical Center. 6. Resides in any of the rural counties served by the UCH-Aurora, UCH-Highlands Ranch, UCHealth North, UCHealth South- UCHealth Memorial Hospital, UCHealth Parkview Hospital, San Juan Cancer Center, RMCC-Pueblo, SCL-St. Mary's, VA, Huntsman Cancer Institute, or Parkview Medical Center with Rural-Urban Continuum Codes (RUCC) codes 4-9. 7. Diagnosed with lung cancer (LC): small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), using incident LC diagnosis according to the International Classification of Diseases for Oncology \[ICD-O\] codes: C34.0, C34.1, C34.2, C34.3, C34.8, C34.9, and C33.9, and other lung cancer variants 8. Stage of diagnosis for SCLC (limited vs. extensive), NSCLC (Stages 0, I, II, IIA, IIIB, IV), according to the American Joint Committee on Cancer Staging \[AJCC\] Tumor Node Metastasis \[TNM\] stages: I-IV) 9. Will receive the following types of breast, bladder, cervix, colon, rectum, lung, head-and-neck cancer treatments (surgery, radiation therapy, chemotherapy, or a combination of those modalities, including neoadjuvant and adjuvant therapy) 10. Diagnosed with head and neck cancer (HNC) using head and neck squamous cell carcinoma (HNSCC) ICD-O codes for the oral cavity (including lip; codes C00.0-C00.6, C00.8, C00.9, C02.0-C02.3, C02.8, C0.2.9, C03.0, C03.1, C03.9-C04.1, C04.8-C05.0, C06.0-C06.2, C06.8, and C06.9), the oropharynx (codes C01.9, C02.4, C05.1, C05.2, C5.8, C5.9, C09.0, C09.1, C09.8-C10.4, C10.8, C10.9, C14.0, C14.2, and C14.8), the hypopharynx (codes C12.9-C13.2, C13.8, and C13.9), and the larynx (codes C32.0- C32.3 and C32.8-C32.9) and histology codes for squamous cell carcinoma (SCC) or its variants (codes 8032, 8050, 8052, 8070-8075, and 8083-8084), and salivary gland cancer (code C07 and variants), and other head and neck cancer variants 11. Stage of diagnosis for HNC (Stages I, II, III, IV) according to the AJCC's TNM stages I-IV 12. Diagnosed with malignant neoplasm of thyroid gland, ICD-10 code: C73, and other thyroid cancer variants 13. Diagnosed with BC using malignant neoplasm of breast ICD-O codes for connective tissue of the breast, codes: C50.0, C50.1, C50.2, C50.3, C50.4, C50.5, C50.6, C50.8, C50.9, and other breast cancer variants. 14. Diagnosed with CC using malignant neoplasm of cervix uteri ICD-O codes: C53.0, C53.1, C53.8, C53.9 and other cervical cancer variants. 15. Diagnosed with CRC using colon and rectum malignant neoplasm ICD-O codes for colon (codes: C18, C18.1, C18.2, C18.3, C18.4, C18.5, C18.6, C18.7, C18.8, C18.9) and rectum (code C20), and other colon and rectum cancer variants. 16. Diagnosed with BLC using malignant neoplasm of ICD-O codes: C67.9 and other bladder cancer varients. Inclusion Criteria Confirmed via Baseline Survey: 17. Rural and medically underserved, defined as meeting the following criteria: * Rural: Resides in a rural county with a RUCC code 4-9 AND, * Underserved population who come from counties meeting any of the "health professional shortage areas" OR "Medically Underserved Areas/Populations" AND/OR 18. Uninsured: No health insurance (public or private insurance) AND/OR 19. Underinsured: (c.1) Public insurance (e.g., Medicaid, Medicare Part B exclusive, VA) (c.2) 10% or more of annual income is spent on out-of-pocket medical expenses Exclusion Criteria Assessed During Screening: 1. Children under 18 years old 2. Individuals who do not speak English or Spanish 3. Individuals not receiving cancer treatment at UCH (Aurora, Highlands Ranch, UCHealth North, UCHealth Memorial Hospital), San Juan Cancer Center, RMCC-Pueblo, St. Mary's or Parkview Medical Center. 4. Diagnosed with primary cancer other than breast, bladder, cervix, colon, rectum, lung, and/or head-and-neck cancer or other type of cancer not listed in the inclusion criteria. 5. Diagnosed with a type of breast, bladder, cervix, colon, rectum, lung, and/or head-and-neck cancer listed under inclusion criteria but will not be treated at one of the collaborating hospital sites, 6. Has already initiated curative treatment for the current episode of cancer. Exclusion Criteria Assessed via Baseline Survey: 7. Individuals from vulnerable populations (e.g., inmates or on probation, homeless\*, and pregnant\*) 8. Decisionally-challenged with cognitive or personality impairment, suicidal ideation or intoxication (alcohol or drugs) at the time of consent or endorsed in baseline survey that interfere with ability to participate in the study. 9. Unable to hear (not including individuals who can hear with an auditory aid).\* 10. Likely inability to track the individual over time (e.g. no permanent address at the time of consent) \*Individuals who become homeless, pregnant, or lose their hearing or permanent address after they have consented and/or assigned to study condition may remain in the study until completion

Adjuvant Abemaciclib for Locoregional Recurrence of HR-positive, HER2-negative Breast Cancer (JCOG2313, AURA)

NCT07190443
Recruiting
Conditions Breast Cancer, Locoregional Recurrence, ...
Phase PHASE3
Enrollment 290
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-15
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Study Details Design, interventions, and primary outcomes

About This Study

The JCOG2313 trial is a multicenter, randomized, phase III study designed to evaluate the efficacy and safety of adjuvant abemaciclib in combination with endocrine therapy versus endocrine therapy alone in patients with hormone receptor (HR)-positive, HER2-negative breast cancer who have undergone curative treatment for their first locoregional recurrence (LRR). Although HR-positive, HER2-negative breast cancer generally has a favorable prognosis, LRR-such as ipsilateral breast tumor recurrence (IBTR), chest wall recurrence, or regional lymph node recurrence-remains a clinically significant event that increases the risk of distant metastasis. While endocrine therapy is standard in this setting, the benefit of adding chemotherapy or other agents remains unclear, and treatment strategies vary widely. Abemaciclib, a CDK4/6 inhibitor, has shown survival benefit in the adjuvant setting for high-risk early breast cancer. However, its role in post-LRR adjuvant treatment has not been evaluated in a randomized setting. This study aims to determine whether the addition of abemaciclib to endocrine therapy can improve invasive disease-free survival (IDFS) in patients after LRR. Eligible patients are randomized 1:1 to receive either endocrine therapy alone or endocrine therapy plus abemaciclib (150 mg twice daily for 2 years). The primary endpoint is IDFS. Secondary endpoints include distant recurrence-free survival, breast cancer-specific survival, overall survival, and safety. A total of 290 patients will be enrolled. Randomization is stratified by site of recurrence, endocrine resistance, perioperative chemotherapy, and institution. Additionally, a prospective ancillary study will assess circulating tumor DNA (ctDNA) as a biomarker for molecular residual disease (MRD). Plasma samples will be collected at predefined time points to evaluate the prognostic and predictive value of ctDNA for relapse and treatment response. The JCOG2313 trial addresses an unmet need in the management of HR-positive, HER2-negative LRR and may contribute to the establishment of a new standard systemic therapy and personalized monitoring strategies.

Design

Study type: Interventional Phases: Phase3 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: Endocrine therapy + Abemaciclib — This intervention consists of adjuvant endocrine therapy in combination with abemaciclib, a CDK4/6 inhibitor, administered to patients with HR-positive, HER2-negative breast cancer who have undergone curative-intent local treatment for their first LRR, including ipsilateral breast tumor recurrence, chest wall recurrence, or regional lymph node recurrence. Abemaciclib is given orally at a dose of 150 mg twice daily for a maximum of 2 years, in accordance with the approved dosing regimen in the adjuvant setting. The choice of endocrine therapy-aromatase inhibitor, tamoxifen, or tamoxifen plus ovarian function suppression-is determined based on menopausal status and prior treatment history.
  • Drug: Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifen — This intervention consists of adjuvant endocrine therapy alone in patients with HR-positive, HER2-negative breast cancer who have undergone curative treatment for their first LRR, including ipsilateral breast tumor recurrence, chest wall recurrence, or regional lymph node recurrence. The choice of endocrine therapy (aromatase inhibitor, tamoxifen, or tamoxifen plus ovarian function suppression) is determined based on the patient's menopausal status and prior treatment history, as specified in the protocol. Treatment is continued for five years or until disease recurrence, unacceptable toxicity, or withdrawal of consent. This intervention does not include CDK4/6 inhibitors.

Primary Outcomes

  • Invasive disease-free survival (Up to 9 years (4 years of accrual and 5 years of follow-up))
Interested in this trial?
Contact the study team directly or view the official listing
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Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Recruiting
Start Date: 2025-02-07
Completion: 2035-02-06
Eligibility
Age: 18 Years and older
Sex: ALL
Volunteers: false
Enrollment: 290 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Japanese Foundation for Cancer Research
Collaborators: Japan Clinical Oncology Group
Contact Information
Study Contact:
Yukinori Ozaki, MD. PhD.
+81335200111
yukinori.ozaki@jfcr.or.jp
Yukinori Ozaki, MD. PhD.
+81335200111
yukinori.ozaki@jfcr.or.jp
Cancer Institute Hospital of JFCR
Interventions
  • Drug: Endocrine therapy + Abemaciclib — This intervention consists of adjuvant endocrine therapy in combination with abemaciclib, a CDK4/6 inhibitor, administered to patients with HR-positive, HER2-negative breast cancer who have undergone curative-intent local treatment for their first LRR, including ipsilateral breast tumor recurrence, chest wall recurrence, or regional lymph node recurrence. Abemaciclib is given orally at a dose of 150 mg twice daily for a maximum of 2 years, in accordance with the approved dosing regimen in the adjuvant setting. The choice of endocrine therapy-aromatase inhibitor, tamoxifen, or tamoxifen plus ovarian function suppression-is determined based on menopausal status and prior treatment history.
  • Drug: Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifen — This intervention consists of adjuvant endocrine therapy alone in patients with HR-positive, HER2-negative breast cancer who have undergone curative treatment for their first LRR, including ipsilateral breast tumor recurrence, chest wall recurrence, or regional lymph node recurrence. The choice of endocrine therapy (aromatase inhibitor, tamoxifen, or tamoxifen plus ovarian function suppression) is determined based on the patient's menopausal status and prior treatment history, as specified in the protocol. Treatment is continued for five years or until disease recurrence, unacceptable toxicity, or withdrawal of consent. This intervention does not include CDK4/6 inhibitors.
Study Locations (1 sites)
Cancer Institute Hospital of JFCR, Koto-ku, Tokyo 135-8550 Japan
Eligibility Criteria
Inclusion criteria: 1. The patient has been diagnosed with the first locoregional recurrence (LRR) after receiving definitive treatment for primary breast cancer. LRR includes one or more of the following: (i) Ipsilateral breast tumor recurrence (ii) Ipsilateral chest wall recurrence (iii) Regional lymph node recurrence 2. At least one LRR lesion must be confirmed by a biopsy, surgical specimen, or cell block from cytology, and must meet all of the following: (i) Pathologically confirmed as invasive breast cancer, or diagnosed as breast cancer in a cytology cell block (in cases where only a cell block is available, the initial primary breast cancer must have been invasive). (ii) Hormone receptor (HR) expression is positive. (iii) HER2 expression is negative. ※ If multiple lesions are pathologically evaluated and any lesion is HR-negative or HER2-positive, the patient is ineligible. 3. No prior diagnosis of distant metastasis of breast cancer. 4. Imaging assessment before registration confirms: No lymph nodes ≥10 mm in short axis No evidence of distant metastasis 5. Age ≥18 years at the time of registration. 6. ECOG Performance Status of 0 or 1. 7. Chemotherapy for LRR is allowed prior to enrollment. 8. The patient does not have bilateral breast cancer. 9. No prior history of treatment with CDK4/6 inhibitors. 10. Written informed consent has been obtained for participation in this clinical trial. Exclusion Criteria: 1. Presence of active double cancer (synchronous malignancy requiring treatment). 2. Ongoing infectious disease requiring systemic therapy. 3. Fever ≥38.0°C at the time of registration. 4. Women who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding; men whose partners intend to become pregnant. 5. Psychiatric illness or symptoms that interfere with daily living and may compromise trial participation. 6. Ongoing systemic administration (oral or IV) of steroids equivalent to ≥10 mg/day of prednisolone or other immunosuppressive agents. 7. Unstable angina (developed or worsened within the past 3 weeks) or myocardial infarction within the past 6 months. 8. Uncontrolled hypertension. 9. Uncontrolled diabetes mellitus despite continuous insulin or oral antidiabetic therapy. 10. Positive for HBs antigen or HCV antibodies (Patients positive for HCV antibodies are not excluded if HCV-RNA is undetectable.) 11. Positive for HIV antibodies (HIV testing is not mandatory.) 12. Presence of interstitial pneumonia, pulmonary fibrosis, or severe emphysema as diagnosed by chest CT.

Pioglitazone Therapy Targeting Fatigue in Breast Cancer

NCT05013255
Recruiting
Conditions Breast Cancer, Muscle Fatigue
Phase PHASE2
Enrollment 30
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-15
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

The goal of this project is to evaluate the therapeutic potential of pioglitazone (PIO) to target underlying mechanisms that promote muscle fatigue in patients with breast cancer. This represents an off-label use of this compound, both in terms of the patient population and the clinical phenotype targeted. The central research hypothesis of this study is that daily pioglitazone will restore transcriptional downregulation of pathways within skeletal that promote fatigue.

Design

Study type: Interventional Phases: Phase2 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: Pioglitazone 15mg — PIO 15mg orally once daily for 2 weeks
  • Drug: Pioglitazone 30 mg — PIO 30mg orally once daily for 2 weeks

Primary Outcomes

  • Muscle Gene Expression (Up to 6 weeks)
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2021-12-23
Completion: 2026-12
Eligibility
Age: 18 Years and older
Sex: FEMALE
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: West Virginia University
Principal Investigators:
  • Kristin H Lupinacci, DO (PRINCIPAL_INVESTIGATOR) - West Virginia University
Contact Information
Study Contact:
Kristin Lupinacci, DO
3042931022
kristin.lupinacci@hsc.wvu.edu
Emidio Pistilli, PhD
304-293-0291
epistilli2@hsc.wvu.edu
Kristin Lupinacci, DO
304-293-1022
kristin.lupinacci@hsc.wvu.edu
West Virginia University Cancer Institute
Interventions
  • Drug: Pioglitazone 15mg — PIO 15mg orally once daily for 2 weeks
  • Drug: Pioglitazone 30 mg — PIO 30mg orally once daily for 2 weeks
Study Locations (1 sites)
West Virginia University Cancer Institute, Morgantown, West Virginia 26506 United States
Eligibility Criteria
Inclusion Criteria: * Subjects must have histologically or cytologically confirmed luminal (ER+/PR+ Her2/neu-) Breast Cancer. * Subjects must have received no prior therapies besides chemotherapy in the neoadjuvant setting. * Subject must have a planned surgical (mastectomy) date within 2 weeks of starting treatment. * 5 Subjects must have normal organ as defined below: * Hemoglobin within normal institutional limits (or \>10?) * Fasting Blood Glucose within normal institutional limits * Serum Creatinine within normal institutional limits * Liver Function (AST and ALT, Alk phosphatase, Total Bilirubin) within normal limits * Subject does not have a prior diagnosis of diabetes or currently taking any medications to lower blood glucose levels. * Subjects must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Prior diagnosis of Congestive Heart Failure (CHF), Bladder cancer, osteoporosis, bariatric surgery * Subjects receiving any other investigational agents or known agents to have a major interaction with PIO to include clopidogrel, gatifloxacin, gemfibrozil, leflunomide, lomitapide, lumateperone, mipomersen, pexideartinib and teriflunomide, insulin, Lyrica, Synthroid. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to Pioglitazone. * Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, unstable angina pectoris, cardiac arrhythmia, active alcoholism or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant or breastfeeding are excluded from this study because Pioglitazone has the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with PIO, breastfeeding should be discontinued if the mother is treated with PIO. These potential risks may also apply to other agents used in this study.

NT-proBNP to Assess Trastuzumab-induced Cardiotoxicity

NCT06340516
Recruiting
Conditions Cardiotoxicity, Breast Cancer, Treatment...
Phase NA
Enrollment 700
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-15
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

Trastuzumab-induced cardiotoxicity (TIC) will be monitored in patients with HER2+ breast cancer undergoing trastuzumab treatment before and after breast cancer surgery. At baseline before start of trastuzumab treatment, echocardiography (ECHO)/multigated Acquisition Scan (MUGA) and measurement of plasma NT-proBNP will be performed. NT-proBNP will be measured again at 6 months and at 12 months of trastuzumab treatment. If elevations in NT-proBNP at 6 months and 12 months occur patients will be referred for ECHO/MUGA. The aim is to assess the sensitivity and specificity to detect TIC with NT-proBNP and whether ECHO/MUGA can be safely replaced by assessment of plasma NT-proBNP levels.

Design

Study type: Interventional Phases: Allocation: Intervention model: Single Group Primary purpose: Diagnostic Masking/blinding: None

Interventions / Regimen

  • Diagnostic Test: Plasma NT-proBNP — Replacement of measurement of plasma NT-proBNP instead of ECHO/MUGA at 6 months and 12 months of trastuzumab treatment to assess cardiotoxicity

Primary Outcomes

  • Sensitivity and specificity of NT-proBNP to detect trastuzumab-induced cardiotoxicity (From inclusion to 24 months after baseline investigation)
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-03-14
Completion: 2029-03-14
Eligibility
Age: 18 Years and older
Sex: ALL
Volunteers: false
Enrollment: 700 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Vastra Gotaland Region
Principal Investigators:
  • Daniel Giglio, Assoc Prof (PRINCIPAL_INVESTIGATOR) - Sahlgrenska University Hospital/University of Gothenburg
  • Barbro Linderholm, Assoc Prof (PRINCIPAL_INVESTIGATOR) - Sahlgrenska University Hospital/University of Gothenburg
Contact Information
Study Contact:
Daniel Giglio, Assoc Prof
+46(0)31-342 16 06
daniel.giglio@pharm.gu.se
Daniel Giglio, Assoc Prof
+46(0)31-342 16 06
daniel.giglio@pharm.gu.se
Jubileumskliniken, Sahlgrenska University Hospital
Interventions
  • Diagnostic Test: Plasma NT-proBNP — Replacement of measurement of plasma NT-proBNP instead of ECHO/MUGA at 6 months and 12 months of trastuzumab treatment to assess cardiotoxicity
Study Locations (1 sites)
Jubileumskliniken, Sahlgrenska University Hospital, Gothenburg, 432 45 Sweden
Eligibility Criteria
Inclusion Criteria: 1. Histological confirmed HER2 positive primary BC planned for adjuvant/neoadjuvant treatment with chemotherapy plus HER2 blocking agents. 2. Patients ≥18 years 3. ECOG/WHO 0-1 4. Adequate organ function for the planned treatment according to local guidelines. 5. No distant metastasis (CT/MRI only if clinically indicated). 6. Negative pregnancy test within 14 days prior to start of treatment. 7. If of childbearing potential, willing to use an effective form of contraception. 8. No other malignancy during the last 5 years except for radically treated basal or squamous cell carcinoma of the skin or CIS of the cervix. 9. Signed informed consent and willingness to follow the trial procedures. Exclusion Criteria: 1. Patients with previous heart disease recommended special follow-up during treatment with high risk of termination of treatment. 2. Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, neurological conditions, physical examination or laboratory findings) that may interfere with the planned treatment or affect patient compliance. 3. Pregnancy and breast feeding. 4. Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ). \-

Evaluating the Use of a Medication 'Switch' vs Guideline-directed Interventions for Relieving Side Effects of Aromatase Inhibitors Among Breast Cancer Patients

NCT07071038
Recruiting
Conditions Breast Cancer, Adjuvant Treatment, Early...
Phase PHASE2
Enrollment 62
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-15
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

Researchers have learned that about 50% of women do not finish the standard 5-year breast cancer treatment with an aromatase inhibitor. An aromatase inhibitor is hormone therapy that lowers the chance of breast cancer coming back (recurring) after surgery by blocking an enzyme in fat tissue called aromatase; aromatase changes other hormones in the body to estrogen. Women who do not complete the standard 5-year treatment are at higher risk of their cancer coming back. The goal of this research is to prevent breast cancer from coming back after surgery by helping women to stay on treatment with aromatase inhibitors. Researchers believe the best path to help women to stay on treatment is to create a better way to manage (control) side effects.

Design

Study type: Interventional Phases: Phase2 Allocation: Randomized Intervention model: Crossover Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: Switch — Participants in the switch arm will receive a new prescription for either anastrozole or exemestane at a dose of 1mg or 25mg daily, respectively. The choice of AI in the first line setting will be at the discretion of the treating oncologist. If side effects persist after the 1st line switch, the participant will have the option to switch to another AI not yet tried, or to tamoxifen at 20mg daily
  • Other: Guideline Directed Intervention (GDI) — Subjects in this group will receive a guideline-directed intervention "GDI" using medication and/or non-medication treatment options according to the National Comprehensive Cancer Network (NCCN) supportive care guidelines. A GDI Book was created for this trial that lists treatment options and resources for each of the common side effects of hormonal therapy and is available for providers and staff to help select treatment options. For less common side effects with limited evidence-based options, treatment will be determined in collaboration with the treating provider and PI, using best available evidence.

Primary Outcomes

  • Change in Endocrine Symptom Burden at 3 months (3 months after randomization)
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2025-10-17
Completion: 2027-08-05
Eligibility
Age: 18 Years and older
Sex: ALL
Volunteers: false
Enrollment: 62 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Dartmouth-Hitchcock Medical Center
Contact Information
Study Contact:
Kristina M. Willey
603-650-7705
Kristina.M.Willey@hitchcock.org
Elaine P Kuhn, MD, MS
Dartmouth Cancer Center
Interventions
  • Drug: Switch — Participants in the switch arm will receive a new prescription for either anastrozole or exemestane at a dose of 1mg or 25mg daily, respectively. The choice of AI in the first line setting will be at the discretion of the treating oncologist. If side effects persist after the 1st line switch, the participant will have the option to switch to another AI not yet tried, or to tamoxifen at 20mg daily
  • Other: Guideline Directed Intervention (GDI) — Subjects in this group will receive a guideline-directed intervention "GDI" using medication and/or non-medication treatment options according to the National Comprehensive Cancer Network (NCCN) supportive care guidelines. A GDI Book was created for this trial that lists treatment options and resources for each of the common side effects of hormonal therapy and is available for providers and staff to help select treatment options. For less common side effects with limited evidence-based options, treatment will be determined in collaboration with the treating provider and PI, using best available evidence.
Study Locations (1 sites)
Dartmouth Cancer Center, Lebanon, New Hampshire 03756 United States
Eligibility Criteria
Inclusion Criteria: * Histologic documentation of DCIS or invasive breast cancer by core needle or incisional biopsy. * The DCIS or invasive cancer must be estrogen receptor alpha (ER)-positive * The invasive cancer must be HER2-negative (IHC 0-1+, or with a FISH ratio of \<1.8 if IHC is 2+ or if IHC has not been done) * Clinical Stage I-III invasive breast cancer or DCIS * Patients for whom adjuvant treatment with one of the following would be clinically indicated: letrozole, anastrozole, exemestane * Patients who anticipate continuing with adjuvant endocrine therapy for a minimum of 2 years at the time of registration * Women over 18 years of age who are post-menopausal, defined as last menstrual period \>2 years prior to registration, or \>1 year prior to registration with FSH and estradiol in post-menopausal range. * Patients must meet the following clinical laboratory criteria: * Absolute neutrophil count (ANC) \>1,000/mm3 and platelet count \> 75,000/mm3 * Total bilirubin \<1.5 x the upper limit of the normal range (ULN). * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 3 x ULN. * Ability to give informed consent. Exclusion Criteria: * Prior endocrine therapy for any histologically-confirmed cancer or prevention of breast cancer in the last 10 years is not allowed. * Any other adjuvant therapy for breast cancer. Exception: Bisphosphonate or denosumab treatment for metabolic bone issues are allowed. * Patients who are prescribed tamoxifen as the first endocrine therapy rather than an aromatase inhibitor. * Women who are pregnant or lactating. * Prisoners.

Neoadjuvant, SBRT With Intratumoural Pembrolizumab Followed by Neoadjuvant Chemotherapy in Breast Cancer

NCT07188246
Recruiting
Conditions Breast Cancer, Breast Cancer Stage II, B...
Phase PHASE2
Enrollment 40
Locations 2 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-15
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

This study will evaluate the immune-priming effects of stereotactic body radiation therapy (SBRT) regimen coupled with two injections of pembrolizumab in high-risk primary breast carcinoma prior to neoadjuvant chemotherapy. Preliminary results from the investigators' local TRIO Trial suggest that SBRT prior to neoadjuvant chemotherapy (NAC) may result in improved response rates due to the combined effect of radiation therapy (RT) and chemotherapy. The investigators aim to augment this effect with the addition of pembrolizumab, a monoclonal antibody that binds to and blocks programmed cell death protein 1 (PD-1).

Design

Study type: Interventional Phases: Phase2 Allocation: Intervention model: Single Group Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Radiation: Radiation — Stereotactic body radiation therapy to the breast
  • Drug: Pembrolizumab (KEYTRUDA®) — Two injections

Primary Outcomes

  • Pathological Complete Response (Measured at time of surgery, typically 6 months after enrollment in trial.)
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2026-01-19
Completion: 2029-02
Eligibility
Age: 18 Years and older
Sex: ALL
Volunteers: false
Enrollment: 40 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Contact Information
Study Contact:
Muriel Brackstone, MD, PhD
519-685-8500
muriel.brackstone@lhsc.on.ca
Kalan S Lynn, M. Sc.
519-646-6100
kalan.lynn@lhsc.on.ca
Muriel Brackstone, MD, PhD
519-685-8712
Muriel.Brackstone@lhsc.on.ca
St. Joseph's Health Care London
Interventions
  • Radiation: Radiation — Stereotactic body radiation therapy to the breast
  • Drug: Pembrolizumab (KEYTRUDA®) — Two injections
Study Locations (2 sites)
St. Joseph's Health Care London, London, Ontario N6A 4V2 Canada
St. Joseph's Health Care London, London, Ontario Canada
Eligibility Criteria
Inclusion Criteria: 1. Invasive ductal carcinoma of any subtype (including invasive mammary carcinoma with lobular features), excluding sarcomatous, signet or metaplastic subtypes. 2. Invasive mammary carcinoma of stages IIB - III (excluding inflammatory breast cancer). Stage IIA is eligible for triple negative and HER2+ breast cancers. a. Clinical staging based on AJCC 8th edition. 3. Lesion palpable by treating physician. 4. Plan to be treated with neoadjuvant chemotherapy. 5. Able to tolerate core needle biopsies and pembrolizumab injection. 6. 18 years of age or older. 7. Able to provide informed consent. Exclusion Criteria: 1. Any serious medical comorbidities or other contraindications to radiotherapy, chemotherapy, or surgery (e.g., uncontrolled diabetes, serious heart condition, etc). 2. Prior treatment for current breast cancer. 3. Previous radiation therapy to the same breast. 4. Inflammatory breast carcinoma. 5. Invasive mammary carcinoma with sarcomatous, signet cell or metaplastic subtypes. 6. Recurrent breast cancer. 7. Clinical or radiologic evidence or suspicion of distant metastatic disease (metastatic workup that requires additional imaging to follow-up on suspicious findings will exclude patients). 8. Any collagen vascular disease precluding radiotherapy at the discretion of the treating radiation oncologist (particularly lupus, scleroderma, dermatomyositis, psoriatic arthritis). 9. No prior stem cell transplantation. 10. Any poorly controlled autoimmune conditions. 11. Current use of corticosteroids or immunosuppressants. 12. Any other malignancy at any site (except non-melanomatous skin cancer) \<5 years prior to study enrollment. Synchronous bilateral breast cancers are acceptable. 13. Inability to tolerate core needle biopsies or pembrolizumab injection. 14. Pregnant or lactating. 15. Under 18 years of age. 16. Inability or unwillingness to provide informed consent. 17. Inability or unwillingness to complete study assessments/interventions and follow-up assessments.

Immunotherapy, Hormone Therapy, and AKT Inhibitor for Premenopausal ER Positive MBC

NCT05720260
Recruiting
Conditions Premenopausal Breast Cancer, Metastatic ...
Phase PHASE2
Enrollment 42
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-15
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Study Details Design, interventions, and primary outcomes

About This Study

This is an open-label randomized phase II study in estrogen receptor positive locally advanced or metastatic breast cancer patients. The main inclusion population are either luminal subtype B by PAM50 analysis or failed less than 2 lines of hormonal therapy for locally advanced or metastatic breast cancer. The subjects have to be premenopausal or perimenopausal and are not allowed to receive any systemic chemotherapy for their locally advanced or metastatic breast cancer. Eligible subjects will be randomized into goserelin/ fulvestrant/ durvalumab (Arm A), goserelin/ fulvestrant/ capivasertib/ durvalumab (Arm B), or goserelin/ fulvestrant/ capivasertib (Arm C) at a 1:1:1 ratio. The primary endpoint is objective response rate (ORR) of the whole other three arm compared to historical goserelin/ fulvestrantcontrol arm. The major secondary endpoint will be progression-free survival or ORR compared among different treatment arms.

Design

Study type: Interventional Phases: Phase2 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: Goserelin — Hormone therapy
  • Drug: Fulvestrant — Hormone therapy
  • Drug: Capivasertib — AKT inhibitor
  • Drug: Durvalumab — immunotherapy

Primary Outcomes

  • Progression-free survival (From time of randomization to death or tumor progression whichever comes first in 200 months)
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2023-01-17
Completion: 2027-01-31
Eligibility
Age: 20 Years and older
Sex: FEMALE
Volunteers: false
Enrollment: 42 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: National Taiwan University Hospital
Principal Investigators:
  • Yen-Shen Lu, MD, PhD (STUDY_CHAIR) - NTUH
Contact Information
Study Contact:
Yen-Shen Lu, MD, PhD
+886-2-23123456
yslu@ntu.edu.tw
Yen-Shen Lu, MD, PhD
886-2-23123456
yslu@ntu.edu.tw
Department of Oncology, National Taiwan University Hospital
Yen-Shen Lu, MD, PhD
Department of Oncology, National Taiwan University Hospital
Interventions
  • Drug: Goserelin — Hormone therapy
  • Drug: Fulvestrant — Hormone therapy
  • Drug: Capivasertib — AKT inhibitor
  • Drug: Durvalumab — immunotherapy
Study Locations (1 sites)
Department of Oncology, National Taiwan University Hospital, Taipei, 100 Taiwan
Eligibility Criteria
Inclusion criteria 1. A histological confirmed ER positive (\>1%) invasive breast cancer. 2. Locally advanced or metastatic disease with at least one measurable target lesion 3. Patients who had not received chemotherapy for locally advanced or metastatic disease 4. Patients have to be (i) either primary resistant to hormonal therapy defined as recurrence developed within 2 years of adjuvant hormonal therapy (ii) or resistant to prior hormonal therapy (failed ≤ 2lines of hormonal therapy for locally advanced or metastatic breast cancer) 5. Patients must be premenopausal or perimenopausal women according the clinical menstrual history or E2 / FSH level based on local hospital guidance. Patient with menopausal status cannot be determined due to ongoing LHRH agonist treatment is allowed if evidence of premenopausal status prior to patients' LHRH agonist usage can be provided. 6. ECOG 0-1 7. Patients must have adequate organ and marrow reserve measured within 14 days(within screening period ) prior to randomization as defined below: * Hemoglobin ≥ 9.0 g/dL; * Absolute neutrophil count ≥ 1,500 /L; * Platelets ≥ 100,000/L; * Total bilirubin ≤ 1.5 x upper normal limit; * AST(SGOT)/ALT(SGPT) ≤ 2.5 x upper normal limit; for patients with liver metastases AST(SGOT)/ALT(SGPT) ≤ 5 x upper normal limit is allowed; * Serum creatinine ≤ 1.5mg/dL or creatinine clearance ≧50ml/min; * aPTT \< 1.5 x upper normal limit (unless on therapeutic anti-coagulation); * Proteinuria ≤ 1+ with urine dipstick, if \> 1+, 24-hour urine protein must be ≤ 1 g. 8. Age older than 20-year-old. 9. All women of childbearing potential must have a negative pregnancy test obtained within 7 days before starting therapy. Patients must not be breastfeeding. 10. Patients with reproductive potential must use effective contraception (hormone or barrier method of birth control) prior to study entry, for the duration of study participation, and for 6 months after the completion of therapy. 11. Patients (or a surrogate) must be able to comply with study procedures and to give signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the clinical study protocol (CSP). The patients (or a surrogate) must be able to provide of signed and dated written ICF prior to any mandatory study specific procedures, sampling, and analyses. 12. Body weight \>30 kg 13. Must have a life expectancy of at least 12 weeks Exclusion criteria Patients fulfilled ANY of the following criteria will be excluded from this trial: 1. Prior therapy with capivasertib, fulvestrant, anti-PD1 or anti-PDL1 immunotherapy 2. Prior chemotherapy for locally advanced or metastatic breast cancer. 3. Radiotherapy with a wide field of radiation within 4 weeks before the first dose of study treatment 4. The tumor is HER-2 positive by IHC 3+ or IHC 2+/ISH positive. 5. Patients have active brain metastases or spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids for at least 4 weeks prior to start of study treatment 6. Other malignancy within 5 years except cured basal cell or squamous cell skin cancer or carcinoma in situ of the cervix. 7. Psychiatric illness or social situation that would preclude study compliance. 8. Serious non-healing wound, ulcer, or bone fracture. 9. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment. 10. Prior minor surgery within 7 days. 11. History of allergic reaction to compounds of similar chemical composition to the study drugs. 12. Pregnancy or lactation. 13. With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment 14. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. 15. Known to have tested positive for human immunodeficiency virus 16. History of allogenic organ transplantation. 17. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]). The following are exceptions to this criterion: a) Patients with vitiligo or alopecia; b) Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement; c)Any chronic skin condition that does not require systemic therapy; d) Patients without active disease in the last 5 years may be included but only after consultation with the study physician; e)Patients with celiac disease controlled by diet alone. 18. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent. Refractory nausea and vomiting, malabsorption syndrome, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection, or other condition that would preclude adequate absorption of capivasertib. 19. History of another primary malignancy except for: a) Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence; b) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; c)Adequately treated carcinoma in situ without evidence of disease 20. History of leptomeningeal carcinomatosis. 21. Previous allogeneic bone marrow transplant or solid organ transplant. 22. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion: 1. Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection) 2. Systemic corticosteroids at physiologic doses not to exceed \<\<10 mg/day\>\> of prednisone or its equivalent 3. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) 23. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP. 24. Any of the following cardiac criteria at screening: * Mean resting corrected QT interval (QTc) \>470 msec obtained from 3 consecutive ECGs * Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (eg, complete left bundle branch block, third degree heart block) * Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, potential for Torsades de Pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval * Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery b