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Showing 20 of 30222 trials
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
NCT02311933
Active, positions filled
Conditions Recurrent Breast Carcinoma, Stage III Br...
Phase PHASE2
Enrollment 81
Locations 560 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Endoxifen Hydrochloride
  • Laboratory Biomarker Analysis
  • Pharmacological Study
  • Tamoxifen Citrate

Primary Outcomes

  • Progression Free Survival (PFS)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Active, positions filled
Start Date: 2015-05-28
Completion: 2027-02-02
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 81 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: National Cancer Institute (NCI)
Principal Investigators:
  • Matthew P Goetz (PRINCIPAL_INVESTIGATOR) - Alliance for Clinical Trials in Oncology
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Endoxifen Hydrochloride
  • Laboratory Biomarker Analysis
  • Pharmacological Study
  • Tamoxifen Citrate
Study Locations (560 sites)
Southern Cancer Center PC-Providence, Mobile, Alabama 36608 United States
Anchorage Associates in Radiation Medicine, Anchorage, Alaska 98508 United States
Anchorage Radiation Therapy Center, Anchorage, Alaska 99504 United States
Alaska Breast Care and Surgery LLC, Anchorage, Alaska 99508 United States
Alaska Oncology and Hematology LLC, Anchorage, Alaska 99508 United States
Alaska Regional Hospital, Anchorage, Alaska 99508 United States
Alaska Women's Cancer Care, Anchorage, Alaska 99508 United States
Anchorage Oncology Centre, Anchorage, Alaska 99508 United States
Katmai Oncology Group, Anchorage, Alaska 99508 United States
Providence Alaska Medical Center, Anchorage, Alaska 99508 United States
Eligibility Criteria
Inclusion Criteria: * PRE-REGISTRATION ELIGIBILITY CRITERIA * Women who agree to undergo a standard of care core biopsy of recurrent or metastatic breast cancer to confirm the ER+ (\>= 10% nuclear staining) and HER2 negative status * Patient must have been previously treated with an aromatase inhibitor (either letrozole, anastrozole or exemestane) either in the adjuvant or metastatic setting, and have one of the following types of primary or secondary endocrine resistant disease * Primary clinical resistance is defined as one of the following: * Recurrence within the first 2 years of adjuvant endocrine therapy while on aromatase inhibitor therapy * Progression within first 6 months of initiating first-line endocrine therapy (either aromatase inhibitor or fulvestrant containing regimen) for the treatment of metastatic breast cancer * Secondary clinical resistance is defined as one of the following: * Recurrence after year 2 while receiving adjuvant aromatase inhibitor therapy, or within 12 months of completing adjuvant aromatase inhibitor therapy * Progression occurring 6 or more months after initiating the first endocrine therapy for metastatic disease (either fulvestrant or aromatase inhibitor containing regimen) * Patients with a history of measurable disease as defined by RECIST criteria or bone only disease are eligible; Note: those patients with non-measurable disease and bone metastases are eligible * No history of tumors involving spinal cord or heart * No current evidence of visceral crisis or lymphangitic spread * No known brain metastases * Women must be postmenopausal * Postmenopausal status is verified by: * Prior bilateral surgical oophorectomy, or * Age \>= 60 years, or * Age \< 60 with no menses for \> 1 year with follicle-stimulating hormone (FSH) and estradiol levels within post menopausal range, according to institutional standard * Prior treatment * No more than two prior chemotherapy regimens in the metastatic setting * Prior treatment with an aromatase inhibitor (either anastrozole, letrozole or exemestane), either in the adjuvant or metastatic setting is required * Unlimited prior endocrine regimens in the metastatic setting, which may have included an everolimus or cyclin dependent kinase (CDK) 4/6 inhibitor (such as palbociclib, abemaciclib or ribociclib) containing regimen * Prior tamoxifen treatment is allowed in the adjuvant setting, but patients must not have experienced relapse within 1 year of stopping tamoxifen * No prior treatment with tamoxifen in the metastatic setting * No prior treatment with endoxifen * Patients who have not fully recovered from acute, reversible effects of prior therapy regardless of interval since last treatment are not eligible to participate in this study * EXCEPTION: neuropathies-if grade 2 neuropathies have been stable for at least 3 months since completion of prior treatment patient is eligible * Not receiving any medications or substances that are strong inhibitors of cytochrome P450 family 2, subfamily D, polypeptide 6 (CYP2D6) * Not receiving any other investigational agents * No uncontrolled intercurrent illness including, but not limited to: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Uncontrolled symptomatic cardiac arrhythmia * Uncontrolled hypertension (defined as blood pressure \> 160/90) * None of the following co-morbid conditions: * Cataracts of grade 2 or greater as per Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 * Retinopathy of grade 2 or greater as per CTCAE version 4.0 * Note: patients that have cataracts that do not require surgery are eligible * Note: serious adverse events will be reported on CTEP-Adverse Event Reporting System (AERS) using CTCAE version (v)5.0 * Deep vein thrombosis/pulmonary embolism (DVT/PE) within the past 6 months * Note: patients that are on anticoagulant therapy for maintenance are eligible as long as the DVT and/or PE occurred \> 6 months prior to enrollment, and there is no evidence for active thrombosis (either DVT or PE) * No other active second malignancy other than non-melanoma skin cancers within 3 years of pre-registration; a second malignancy is not considered active if all treatment for that malignancy is completed and the patient has been disease-free for at least 3 years prior to pre-registration * Eastern Cooperative Oncology Group (ECOG) performance status: 0-2 * Able to swallow oral formulation of the study agent * Hemoglobin \>= 9 g/dL * Platelet count \>= 75,000/mm\^3 * Creatinine =\< 1.5 x upper limits of normal (ULN) * Total bilirubin =\< 1.5 x upper limits of normal (ULN) * Aspartate aminotransferase (AST) =\< 2.5 x upper limits of normal (ULN); for patients with liver metastasis: =\< 5 x upper limits of normal (ULN) * REGISTRATION ELIGIBILITY CRITERIA * Patients with either measurable disease as defined by RECIST criteria or bone only disease are eligible; Note: those patients with both non-measurable disease and bone metastases are eligible * Non-measurable bone only disease: Non-measurable bone only disease may include any of the following: blastic bone lesions, lytic bone lesions without a measurable soft-tissue component, or mixed lytic-blastic bone lesions without a measurable soft-tissue component * Lytic bone lesions, with an identifiable soft tissue component, evaluated by computed tomography (CT) or magnetic resonance imaging (MRI), can be considered as measurable lesions if the soft tissue component otherwise meets the definition of measurability previously described * No tumors involving spinal cord or heart * No visceral crisis, lymphangitic spread or known brain metastases: visceral crisis is not the mere presence of visceral metastases, but implies severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of disease * Histologic confirmation, from the A011203 pre-registration biopsy, by institutional/local pathologist of either locally advanced or metastatic breast cancer that is estrogen receptor positive and HER2 negative; those patients with bone only disease with either no tumor or insufficient tumor for ER/progesterone receptor (PR) and HER2 staining after the bone biopsy are still eligible to participate in this study * Estrogen receptor positive disease is defined as \> 10% nuclear staining * HER2 negative disease as per 2013 American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines, one of the following must apply: * 0 or 1+ by immunohistochemistry (IHC) and not amplified by in situ hybridization (ISH) * 0 or 1+ by IHC and ISH not done * 2+ by IHC and not amplified by ISH or * IHC not done and not amplified by ISH * None of the following therapies are allowed prior to registration: * Chemotherapy =\< 2 weeks * Immunotherapy =\< 2 weeks * Biologic therapy =\< 2 weeks * Hormonal therapy =\< 2 weeks * Monoclonal antibodies =\< 2 weeks * Radiation therapy =\< 2 weeks * Anti-Her-2 or other "targeted" (e.g. mammalian target of rapamycin \[mTOR\]) therapy =\< 2 weeks * NOTE : Any toxicities derived from these therapies must be =\< grade 2 prior to starting study therapy
Triple Negative Breast Cancer and Germline Hereditary Breast and Ovarian Cancer Mutation Carrier Registry
NCT02302742
Recruiting
Conditions Breast Cancer, Hereditary Breast and Ova...
Phase Not Applicable
Enrollment 1500
Locations 11 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Primary Outcomes

  • Prevalence of germline mutations (such as BRCA1/2 mutations) in patients with TNBC
  • . Predictors of response to neo/adjuvant chemotherapy in patients with TNBC
  • Long term Disease free and overall survival rates in TNBC patients treated with different systemic therapies
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2011-03-22
Completion: 2026-12
Eligibility
Age: No restriction
Sex: ALL
Volunteers: true
Enrollment: 1500 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Kansas Medical Center
Principal Investigators:
  • Priyanka Sharma, MD (PRINCIPAL_INVESTIGATOR) - University of Kansas Medical Center
Contact Information
Study Contact:
Joshua Staley
913-588-8548
jstaley2@kumc.edu
Interventions
N/A
Study Locations (11 sites)
Hays Medical Center Dreiling-Schmidt Cancer Institute, Hays, Kansas 67601 United States
KCCC West, Kansas City, Kansas 66112 United States
KCCC Overland Park, Overland Park, Kansas 66210 United States
Overland Park Regional Medical Center, Overland Park, Kansas 66215 United States
Salina Regional Health Center - Tammy Walker Cancer Center, Salina, Kansas 67401 United States
The University of Kansas Cancer Center, Westwood, Kansas 66205 United States
Universtiy Health, Kansas City, Missouri 64108 United States
KCCC South, Kansas City, Missouri 64131 United States
Research Medical Center, Kansas City, Missouri 64132 United States
KCCC - North, Kansas City, Missouri 64154 United States
Eligibility Criteria
Inclusion criteria include: Triple Negative Breast Cancer * ER/PR \<10% and HER negative per current ASCO/CAP guidelines * Stages I-IV * Any age at diagnosis * Patient must be within 5 years of diagnosis * Eligible regardless of genetic testing status * Genetic testing recommended for patients meeting NCCN and Medicare guidelines AND/OR Germline mutation Carriers * Patients with deleterious or uncertain mutations in HBOC genes (BRCA, PTEN, P53, -PALB2 etc) are eligible regardless of type/site of cancer * Healthy patients harboring mutations also eligible * There is no time limit from the time of diagnosis of cancer and enrollment. * Eligible regardless of personal history of cancer Exclusion Criteria include: Triple Negative Breast Cancer -Patient is not within five years of diagnosis Germline mutation Carriers: -Patient only carries a HBOC mutation that is classified as "polymorphism" of "favor polymorphism"
SAFIR02_Breast - Efficacy of Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer
NCT02299999
Active, positions filled
Conditions Metastatic Breast Cancer
Phase PHASE2
Enrollment 1460
Locations 25 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • AZD2014
  • AZD4547
  • AZD5363
  • AZD8931
  • Selumetinib

Primary Outcomes

  • Progression-free survival in the targeted drug arm compared to standard maintenance therapy arm
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Active, positions filled
Start Date: 2014-04-07
Completion: 2025-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 1460 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: UNICANCER
Collaborators: Fondation ARC, AstraZeneca
Principal Investigators:
  • Fabrice ANDRE, Pr (PRINCIPAL_INVESTIGATOR) - Gustave Roussy, Villejuif
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • AZD2014
  • AZD4547
  • AZD5363
  • AZD8931
  • Selumetinib
Study Locations (25 sites)
Institut de Cancérologie de l'Ouest/Paul Papin, Angers, France
Institut Sainte-Catherine, Avignon, France
Polyclinique Bordeaux Nord Aquitaine, Bordeaux, 33077 France
Institut Bergonié, Bordeaux, France
Centre François Baclesse, Caen, France
Centre Jean Perrin, Clermont-Ferrand, France
Centre Georges François Leclerc, Dijon, 21079 France
Chd Vendee, La Roche-sur-Yon, 85925 France
Centre Oscar Lambret, Lille, France
Chu Dupuytren, Limoges, 87000 France
Eligibility Criteria
Screening phase: Inclusion Criteria: * Women (or men) with histologically proven breast cancer * Metastatic relapse or progression or stage IV at diagnosis * No Her2 over-expression * Patients with metastases that can be biopsied, except bone metastases * Patients who are eligible for a first or a second line of chemotherapy in metastatic setting (left to the discretion of investigators), or who are currently treated with a first or second line of chemotherapy with a maximum of 2 cycles at the time of biopsy. Screening of patients currently treated with a second line chemotherapy should have a stable disease * For patients with ER+ disease, relapse or progression occurred during endocrine therapy, whatever the line, or less than 12 months after the end of endocrine therapy in adjuvant context * Age ≥18 years * WHO Performance Status 0/1 * Presence of measurable target lesion according to RECIST criteria v1.1 Exclusion criteria: * Spinal cord compression and/or symptomatic or progressive brain metastases * Bone metastases when this is the only site of biopsiable disease * Patients with all target lesions in a previously irradiated region, except if clear progression has been observed prior to study in at least one of them * Patient who received more than 2 lines of chemotherapy at the time of the biopsy * Tumor progression observed with the current line of treatment when under 2nd line * Patients who already had a genomic profile (both CGH and NGS analysis) in which no SAFIR02 targetable alterations have been identified * Abnormal coagulation contraindicating biopsy * Inability to swallow * Major problem with intestinal absorption Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG Any factors increasing the risk of QTc prolongation or arrhythmic events Experience of any of the following in the preceding 12 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, past or current uncontrolled angina pectoris, congestive heart failure NYHA Grade ≥2, torsades de pointes, current uncontrolled hypertension, cardiomyopathy Past medical history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis which requires steroid treatment or any evidence of clinically interstitial lung disease Previous or current malignancies of other histologies within the last 5 years, Evidence of severe or uncontrolled systemic disease (active bleeding diatheses, or active Hepatitis B, C and HIV) * diagnosis of acne rosacea, severe psoriasis and severe atopic eczema * Prior exposure to anthracyclines or mitoxantrone with cumulative exposure in excess of 360 mg/m² for doxorubicin, 720 mg/m² for epirubicin, or 72 mg/m² for mitoxantrone * Previous treatment with the same agent or in the same class as one of those used in the SAFIR02 trial (patients who received this previous targeted agent without the target prescreening are eligible but may not be eligible for randomisation in substudy 1 if the treatment allocated by the MTB is in the same class) History of retinal degenerative disease, eye injury or corneal surgery in the previous 3 months, past history of central serous retinopathy or retinal vein occlusion, intraocular pressure \>21 mmHg, or uncontrolled glaucoma. * History of hemorrhagic or thrombotic stroke, TIA or other CNS bleeds * Renal disease including glomerulonephritis, nephritic syndrome, Fanconi syndrome, renal tubular acidosis * Patients using drugs that are known potent inhibitors or potent inducers or substrates of cytochrome P450 Randomized phase: Substudy 1: Inclusion Criteria: * Patients who received 6 to 8 cycles of chemotherapy, or having received at least 4 cycles of chemotherapy definitively stopped for toxicity reasons, and who are presenting a SD or PR at randomization * presenting at least one genomic alteration from the predefined list * Age ≥25 years for patients planned to receive AZD4547 * 28-day wash-out period from chemo prior to randomization and grade ≤1 residual toxicities Exclusion Criteria: * More than 2 previous lines of chemotherapy for metastatic disease before randomization * Life expectancy \<3 months * Disease progression occuring at any time during chemotherapy and before randomization or toxicity that led to the discontinuation of the last chemotherapy before 4 full cycles have been delivered * Less than 28 days from radiotherapy, less than 2 weeks from palliative radiation * Patients previously treated with a targeted agent in the same class as the agent to be given to the patient in substudy 1 * Toxicities of grade ≥2 from any previous anti-cancer therapy * Altered haematopoietic or organ function * Mean resting corrected QT interval (QTc) \>480 msec (or QTcF \>450 msec) obtained from 3 consecutive ECGs * Left ventricular ejection fraction (LVEF) \<55% (MUGA scan or Echocardiogram) * Altered ophthalmic conditions confirmed by an ophthalmology specialist for patients likely to be treated with AZD4547 orAZD8931 or Selumetinib * Patients using non-substitutable drugs, that are known to prolong QT interval or induce Torsades de Pointes, when they are supposed to be treated with vandetanib, AZD5363 or AZD8931 Substudy 2: Inclusion Criteria: * Patients who received 6 to 8 cycles of chemotherapy, or having received at least 4 cycles of chemotherapy definitively stopped for toxicity reasons, and who are presenting a SD or a RP at randomization * Patients not eligible to substudy 1 * wash-out period of at least 15 days for weekly (except monoclonal antibodies) or daily chemotherapies or 28 days for other chemotherapies from last chemotherapy administration prior to randomization and grade ≤1 residual toxicities Exclusion Criteria: * More than 2 previous lines of chemotherapy for metastatic disease before randomization * Life expectancy \<3 months * Disease progression occuring at any time during chemotherapy and before randomization or toxicity that led to the discontinuation of the last chemotherapy before 4 full cycles have been delivered * Any previous treatment with a PD1 or PD-L1 inhibitor, including MEDI4736 * Toxicities of grade ≥2 from any previous anti-cancer therapy * Altered haematopoietic or organ function * Mean resting QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 consecutive ECGs using Bazett's Correction * Current or prior use of immunosuppressive medication within 28 days before the first dose of MEDI4736, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid * Active or prior documented autoimmune disease within the past 2 years NOTE: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded * History of primary immunodeficiency
[18F]ISO-1 Positron Emission Tomography (PET/CT) in Primary Breast Cancer
NCT02284919
Active, positions filled
Conditions Breast Cancer, Breast Neoplasm
Phase PHASE1
Enrollment 30
Locations 1 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • [18F]ISO-1

Primary Outcomes

  • Correlate [18F]ISO-1 uptake with pathologic assays measuring cellular proliferation rates (e.g. Ki-67)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Active, positions filled
Start Date: 2015-03-11
Completion: 2026-11
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Pennsylvania
Principal Investigators:
  • Elizabeth McDonald, MD, PhD (PRINCIPAL_INVESTIGATOR) - University of Pennsylvania
  • David Mankoff, MD, PhD (PRINCIPAL_INVESTIGATOR) - University of Pennsylvania
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • [18F]ISO-1
Study Locations (1 sites)
University of Pennsylvania Hospital, Philadelphia, Pennsylvania 19104 United States
Eligibility Criteria
Inclusion Criteria: 1. Adult patients, at least 18 years of age 2. Known or suspected breast cancer with at least one breast lesion that is 1 cm or greater in size by standard imaging (e.g. mammography, ultrasound or breast MRI) 3. Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures Exclusion Criteria: 1. Females who are pregnant at the time of screening will not be eligible for this study, urine or serum pregnancy test will be performed in women of child-bearing potential at the time of screening. 2. Inability to tolerate imaging procedure in the opinion of an investigator or treating physician 3. Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study. 4. Unwilling or unable to provide informed consent.
Clinical Validation of the Role of microRNA Binding Site Mutations in Cancer Risk, Prevention and Treatment
NCT02253251
Recruiting
Conditions Cancer
Phase Not Applicable
Enrollment 15000
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • KRAS-variant and microRNA binding site mutation testing

Primary Outcomes

  • Measuring the prevalence of the KRAS-variant in certain populations Prevalence of the KRAS-variant in BRCA negative breast cancer patients
  • Comparing the impact of interventions in KRAS-variant versus non-KRAS variant populations
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2014-09
Completion: 2035-09
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 15000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: MiraKind
Principal Investigators:
  • Joanne Weidhaas, MDPhD (PRINCIPAL_INVESTIGATOR) - MiraKind
Contact Information
Study Contact:
Joanne Weidhaas, MDPhD
203-671-1308
joanne@mirakind.org
Joanne Weidhaas
424-387-8100
Joanne@miradx.com
Interventions
  • KRAS-variant and microRNA binding site mutation testing
Study Locations (1 sites)
MiraKind, Los Angeles, California 90025 United States
Eligibility Criteria
Inclusion Criteria: * Personal or family history of cancer * Personal history of endometriosis, or autoimmunity Exclusion Criteria: * Younger than 18 * Non-english speaking and unable to understand and sign the consent
Follow-up of Early Breast Cancer by Dynamic Evaluation of CEA and CA 15.3 Followed by 18FDG-PET
NCT02261389
Active, positions filled
Conditions Breast Cancer
Phase NA
Enrollment 1507
Locations 7 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Arm B, tumor markers assessment

Primary Outcomes

  • Time interval between date of randomization and date of diagnosis of disease distant recurrence
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2014-09
Completion: 2030-12
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 1507 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborators: PONS-S (Patientenorientierte Nachsorge-Stiftung), Augsburg, Germany, Azienda ULSS 12 Veneziana, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Principal Investigators:
  • Claudio Zamagni, MD (PRINCIPAL_INVESTIGATOR) - Azienda Ospedaliero-Universitaria di Bologna
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Arm B, tumor markers assessment
Study Locations (7 sites)
Azienda Sanitaria dell'Alto Adige - Ospedale di Bressanone, Brixen, Bolzano 39042 Italy
Azienda Sanitaria dell'Alto Adige - Ospedale di Merano, Merano, Bolzano 39012 Italy
ASL13 - Presidio Ospedaliero Mirano, U.O.C. Oncologia ed Ematologia Oncologica, Mirano, Venezia 30035 Italy
Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii, Bologna, 40138 Italy
Azienda Sanitaria dell'Alto Adige - Ospedale Centrale di Bolzano, Bolzano, 39100 Italy
Azienda Ospedaliero-Universitaria di Ferrara, Ferrara, 44124 Italy
IRCCS Azienda Ospedaliera S. Maria Nuova di Reggio Emilia, Reggio Emilia, 42123 Italy
Eligibility Criteria
Inclusion Criteria: * Male or female ≥18 years. * Histologically confirmed stage I-III epithelial breast cancer. * Adequate surgery of breast and axilla: 1. patients must have undergone either a total mastectomy or breast conserving surgery 2. surgical margins of the resected specimen must be histologically free of invasive tumor. * Cohort 1: if chemotherapy and/or radiotherapy are indicated the patients must be randomized between 1 month and 2 months from the end of chemotherapy and/or radiotherapy; if only hormonal adjuvant therapy is indicated the patients must be randomized within 3 months from the completion of surgery * Cohort 2: patients must be randomized in the trial after 5 years of follow-up without relapse (but within year 6) * Signed informed consent obtained prior to any study-specific procedures. Exclusion Criteria: * Histologically confirmed stage 0 epithelial breast cancer (carcinoma in situ). * Special histologies with a high or low risk of relapse (i.e. sarcoma and tubular carcinoma) * T1a and T1b tumors with all the following characteristics: G1-2 and N0 and RE \> 10%, RPg \> 10% and HER2 negative and Ki67≤14% * Evidence of distant metastases * Patients participating to other clinical trials requiring follow-up not equal to standard * Previous history of cancer within 5 years from randomization (except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, stage I uterine cancer, or other non-breast malignancies with an outcome similar to those mentioned above)
Energy Balance and Breast Cancer Aspects-II
NCT02240836
Active, positions filled
Conditions DCIS Grade 3, Stage I Breast Cancer, Sta...
Phase NA
Enrollment 545
Locations 2 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Intervention. Exercise

Primary Outcomes

  • VO2max
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2014-09
Completion: 2027-10-31
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 545 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Oslo University Hospital
Collaborators: St. Olavs Hospital, The Research Council of Norway
Principal Investigators:
  • Inger Thune, MD. PhD (PRINCIPAL_INVESTIGATOR) - The Department of Oncology, Ullevål, Oslo University Hospital
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Intervention. Exercise
Study Locations (2 sites)
Oslo University Hospital, Oslo, Norway
St. Olavs Hospital, Trondheim, 7000 Norway
Eligibility Criteria
Inclusion Criteria: * Age 18-75 years * Newly diagnosed DCIS grade 3 or invasive breast cancer stage I, II, histologically verified. * All ethnic groups, but participants have to speak and write the Norwegian language. * Ability to join and maintain an intervention for 12 months Exclusion Criteria: * Verified heart disease * Dysregulated diabetes mellitus or thyroid disorders * Muscular and skeletal or other disorders excluding regular physical activity performance * Body Mass Index \>40 kg/m2 * Previous surgical treatment for obesity * Travel distance \>1.5 hour from home to study site
Weekly Paclitaxel and Cisplatin to Treat Hormone Receptor Positive and Triple Negative Breast Cancer Patients
NCT02221999
Active, positions filled
Conditions Tubular Breast Cancer, Mucinous Breast C...
Phase PHASE2, PHASE3
Enrollment 250
Locations 12 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Paclitaxel
  • Cisplatin
  • Gonadotropin-releasing hormone agonist
  • Letrozole

Primary Outcomes

  • pathological complete remission rate
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2, PHASE3
Status: Active, positions filled
Start Date: 2013-09
Completion: 2029-01
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 250 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: RenJi Hospital
Principal Investigators:
  • Jinsong Lu (PRINCIPAL_INVESTIGATOR) - RenJi Hospital
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Paclitaxel
  • Cisplatin
  • Gonadotropin-releasing hormone agonist
  • Letrozole
Study Locations (12 sites)
Department of Thyroid and Breast Gland Surgery,Shenzhen Longgang Central Hospital, Shenzhen, Guangdong China
HanDan Central Hospital, Handan, Hebei 056001 China
The First Affiliated Hospital of University of South China, Hengyang, Hunan 421001 China
Department of Thyroid and Breast Surgery, The Affiliated Hospital of Inner Mongolia Medical Collage, Hohhot, Inner Mongolia China
The second people's hospital of Kunshan city, Kunshan, Jiangsu 215300 China
Department of Medical Oncology, General Hospital of Ningxia Medical University, Yinchuan, Ningxia China
Zhongshan Hospital, Shanghai, Shanghai Municipality 200032 China
Shanghai Jiaotong University School of Medicine, Renji Hospital, Shanghai, Shanghai Municipality 200127 China
Yueyang hospital of integrated traditional Chinese and Western medine, Shanghai, Shanghai Municipality 200437 China
Armed Police Corps Hospital of Shanghai, Shanghai, Shanghai Municipality 201103 China
Eligibility Criteria
Inclusion Criteria: 1. Women aged ≥18years and ≤70 years; 2. At least on measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST). Histologically confirmed invasive breast cancer, tumor size ≥2 cm, T2-4 N0-3M0; 3. ER/PR/HER-2 and Ki-67 status detected on core biopsy. ER and/or PR positive was defined as \>1% stained cells.HER2-positive is defined as immuno-histochemistry (IHC) 3+ or the ratio of HER2 gene signals to chromosome 17 signals \>2.0 or HER2 gene copy \>6.0. 4. No prior systemic or loco-regional treatment of breast cancer; 5. Adequate bone marrow function:WBC≥4.0×109/L, Absolute neutrophil count(ANC)≥1.5×109/L, Platelets(PLT)≥100×109/L, Hemoglobin(Hb)≥90g/L;aspartate aminotransferase(AST),Alanine aminotransferase (ALT)≤1.5 upper normal limit (UNL), creatinine≤1.5 UNL, bilirubin≤1.5UNL; 6. No obvious main organs dysfunction. Exclusion Criteria: 1. Unwilling or unable to use an acceptable method of contraception in 8 weeks (including 8 weeks) after final dose of test drug; 2. Patient is pregnant or breast feeding; 3. Inflammatory breast cancer and metastatic breast cancer; 4. Any evidence of sense or motor nerve disorders; 5. Patients with medical conditions taht indicate intolerant to neoadjuvant therapy, including uncontrolled cardiovascular disease, severe infection; 6. Any concurrent malignancy other than breast cancer; 7. Know severe hypersensitivity to any drugs in this study.
Spirometric Response to Bronchial Thermoplasty in Patients With Severe Asthma
NCT02241265
Recruiting
Conditions Asthma
Phase Not Applicable
Enrollment 20
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Primary Outcomes

  • The primary endpoints are improvements in prebronchodilator FEV1 and FVC.
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2014-02
Completion: 2026-09
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 20 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Oklahoma
Principal Investigators:
  • Brent Brown, MD (PRINCIPAL_INVESTIGATOR) - OUHSC
Contact Information
Study Contact:
Brent Brown, MD
405-271-6173
brent-brown@ouhsc.edu
Clinical Trials Manager
research@ouhsc.edu
Interventions
N/A
Study Locations (1 sites)
OUHSC, Oklahoma City, Oklahoma 73104 United States
Eligibility Criteria
Inclusion Criteria: * \>18 years of age * severe asthma diagnosis * decreased FEV1 Exclusion Criteria: * \< 18 years of age
mTORC1/2 Inhibitor AZD2014 or the Oral AKT Inhibitor AZD5363 for Recurrent Endometrial and Ovarian
NCT02208375
Active, positions filled
Conditions BRCA1 Mutation Carrier, BRCA2 Mutation C...
Phase PHASE1
Enrollment 159
Locations 1 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Capivasertib
  • Laboratory Biomarker Analysis
  • Olaparib
  • Pharmacological Study
  • Vistusertib

Primary Outcomes

  • Maximum tolerated dose
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Active, positions filled
Start Date: 2014-11-11
Completion: 2028-06-30
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 159 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Principal Investigators:
  • Shannon N Westin (PRINCIPAL_INVESTIGATOR) - M.D. Anderson Cancer Center
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Capivasertib
  • Laboratory Biomarker Analysis
  • Olaparib
  • Pharmacological Study
  • Vistusertib
Study Locations (1 sites)
M D Anderson Cancer Center, Houston, Texas 77030 United States
Eligibility Criteria
Inclusion Criteria: * Any histologically confirmed locally advanced recurrent endometrial adenocarcinoma (except for carcinosarcoma), recurrent high-grade serous ovarian/primary peritoneal/fallopian tube carcinoma, or deleterious BRCA mutant recurrent ovarian/primary peritoneal/fallopian tube cancer for whom no curative option is available will be eligible; any patient proven to have metastatic triple negative breast cancer, defined from standard pathologic assays as negative for estrogen receptor (ER) and progesterone receptor (PR) (\< 10% tumor staining) will be eligible * Patients may have unlimited prior chemotherapeutic regimens for management of recurrent locally advanced endometrial carcinoma, recurrent ovarian carcinoma, or metastatic triple negative breast cancer; treatment as frontline therapy for metastatic disease is acceptable; patients who have received prior PARP inhibitors, MTOR inhibitors, and/or AKT inhibitors are allowed to participate; patients may have progressed on prior PARP inhibitor, MTOR inhibitor, or AKT inhibitor but they may not have discontinued drug for toxicity * With the exception of alopecia, any unresolved toxicities from prior chemotherapy should be no greater than Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0) grade 1 at the time of starting study treatment * Patients should have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; if no measurable disease is present, patients should have assessable disease such as pleural effusion, ascites, with cancer antigen 125 (CA125) Gynecological Cancer Intergroup (GCIG) criteria * Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Women of child-bearing potential and their partners must agree to use contraception (hormonal or barrier method of birth control; abstinence) from study entry until 30 days after last dose of study drug; male partners should be instructed to use contraception during the study period; women of child-bearing potential (intact uterus) should have a negative serum pregnancy test; if a woman becomes pregnant or suspects she is pregnant while on study, she should tell her treating physician immediately; female patients must have evidence of non-child-bearing potential by fulfilling 1 of the following at screening: a) post-menopausal defined as \> 50 years old and amenorrheic for \>= 12 consecutive months following cessation of all exogenous hormonal treatments; b) documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy, but not tubal ligation * Women must not breast-feed while taking the study medications * Absolute neutrophil count \>= 1,500/mcL (measured within 28 days prior to entry/randomization) * Hemoglobin \>= 10 gm/dL (measured within 28 days prior to entry/randomization) * Platelets \>= 100,000/mcL (measured within 28 days prior to entry/randomization) * Presence of \< 4% blasts on hematologic studies (measured within 28 days prior to entry/randomization) * Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) (measured within 28 days prior to entry/randomization) * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal unless the liver is involved with tumor, in that case, ALT/AST must be =\< 5 x ULN (measured within 28 days prior to entry/randomization) * Creatinine clearance \> 50 mL/min (assessed by Cockcroft Gault estimation) (measured within 28 days prior to entry/randomization) * Patients with type II diabetes mellitus that is well controlled by dietary measures alone and have a hemoglobin A1c (HgA1c) \< 8% are eligible to participate; patients found to have a fasting glucose \>= 7 mmol/L (\>= 126 mg/dL) or glycosylated hemoglobin \> 8% (64 mmol/mol) at screening should be assessed for appropriate management according to local policy; those in whom dietary measures alone provide good diabetic control will be eligible for inclusion; type I or II diabetes mellitus requiring either insulin or oral hypoglycemics for routine management will be excluded * Patients must be able to swallow and tolerate oral medications and not have gastrointestinal illnesses that would preclude absorption of AZD2014, AZD5363, or olaparib (e.g. uncontrolled nausea, vomiting, or diarrhea; malabsorption syndrome; ulcerative disease) * Participants' life expectancy must be \> 4 months * Patients must be able to understand and willing to sign an informed consent * FOR EXPANSION PHASE ONLY: For the expansion phase, patients must have measurable disease accessible for biopsy * FOR EXPANSION PHASE ONLY: For the expansion phase, patients must have archival specimens from the time of primary or recurrence diagnosis Exclusion Criteria: * Patients receiving any other investigational agents or any additional anti-cancer agents * Patients who have endometrial carcinosarcoma; patients with ovarian cancer who have histology other than high-grade serous in the absence of a deleterious BRCA mutation; if the patient has a deleterious BRCA mutation, any histology will be accepted * Patients who have recurrences that are amenable to potentially curative treatment with radiation therapy or surgery * Patients who have a history of other malignancies except for basal cell or squamous cell skin cancer, in situ cervical cancer, unless they have been disease-free for at least five years; patients may have dual primaries of endometrial, ovarian or breast cancer * Patients who have a history of myelodysplastic syndrome * Patients who have symptomatic, uncontrolled spinal cord compression and/or brain metastases; a scan to confirm absence of brain metastasis is not required; patients can receive a stable dose of corticosteroids (except those prohibited per protocol) before/during study if these were started at least 28 days prior to entry * Patients who have had prior chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents, and any investigational agents within 28 days of starting study treatment (not including palliative radiotherapy at focal sites), or corticosteroids that are prohibited per protocol within 14 days of starting study treatment * Patients who have had major surgery within 28 days prior to entry into the study or be recovering from any effects of surgery; patients who have had minor surgery within 2 weeks prior to entry into the study * Patients who have a resting electrocardiogram (ECG) with a Fridericia corrected QT (QTcF) interval of \>= 470 msec at 2 or more time points within a 24 hour period or a family history of long QT syndrome * Patients who have required a blood transfusion within 28 days prior to study start * Patients who have received any hemopoietic growth factors (e.g., filgrastim \[G-CSF\], sargramostim \[GM-CSF\]) within 2 weeks prior to study start * Patients receiving certain medications and/or substances that are prohibited within stated wash-out periods * Patients with known hypersensitivity to olaparib, AZD5363, AZD2014 or any of their excipients; patients with a history of hypersensitivity to drugs with a similar chemical structure or class to olaparib, AZD5363, or AZD2014 * Patients who have experienced intolerable adverse events per treating investigator due to other PARP inhibitors, mTOR inhibitors, PI3 kinase inhibitors, or AKT inhibitors * Patients who have experienced any of the following procedures or conditions currently or in the preceding 12 months: a) coronary artery bypass graft; b) angioplasty; c) vascular stent; d) myocardial infarction; e) angina pectoris; f) congestive heart failure New York Heart Association grade \>= 2; g) ventricular arrhythmias requiring continuous therapy; h) supraventricular arrhythmias including atrial fibrillation, which are uncontrolled; i) hemorrhagic or thrombotic stroke, including transient ischemic attacks or any other cen
Vaccine Therapy in Treating Patients With HER2-Negative Stage III-IV Breast Cancer
NCT02157051
Active, positions filled
Conditions HER2 Negative Breast Carcinoma, Recurren...
Phase PHASE1
Enrollment 42
Locations 1 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine
  • Laboratory Biomarker Analysis

Primary Outcomes

  • Incidence of toxicity per Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events version 4.0
  • Immunologic efficacy defined as achievement of a statistically significant increase in Th1 cell immunity for at least 50% of the immunizing antigens as compared to baseline
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Active, positions filled
Start Date: 2015-06
Completion: 2026-09-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 42 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: University of Washington
Collaborators: United States Department of Defense, Breast Cancer Alliance
Principal Investigators:
  • Mary Disis (PRINCIPAL_INVESTIGATOR) - Fred Hutch/University of Washington Cancer Consortium
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine
  • Laboratory Biomarker Analysis
Study Locations (1 sites)
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington 98109 United States
Eligibility Criteria
Inclusion Criteria: * Patients with stage III-IV HER2 negative breast cancer treated with primary or salvage therapy and now have: * No evidence of disease (NED), or * Stable bone only disease * Patients who have completed standard of care and recovered with mild to no residual toxicity from recent therapy * Patients must be at least 28 days post cytotoxic chemotherapy, and/or monoclonal antibody therapy (excluding bone-directed therapy), prior to enrollment * Patients must be at least 28 days post systemic steroids prior to enrollment * Patients on bisphosphonates, denosumab, and/or endocrine therapy are eligible * Patients must have Eastern Cooperative Oncology Group (ECOG) performance status score of =\< 1 * Patients must have recovered from major infections and/or surgical procedures, and in the opinion of the investigator, not have any significant active concurrent medical illnesses precluding protocol treatment * Estimated life expectancy of more than 6 months * White blood cells (WBC) \>= 3000/mm\^3 (within 30 days of first vaccination) * Lymphocyte count \>= 800/mm\^3 (within 30 days of first vaccination) * Platelet count \>= 75,000/mm\^3 (within 30 days of first vaccination) * Hemoglobin (Hgb) \>= 10 g/dl (within 30 days of first vaccination) * Serum creatinine \<= 1.2 mg/dl or creatinine clearance \> 60 ml/min (within 30 days of first vaccination) * Total bilirubin \<= 1.5 mg/dl (within 30 days of first vaccination) * Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) \<= 2 times upper limit of normal (ULN) (within 30 days of first vaccination) * Blood glucose \< 1.5 ULN (within 30 days of first vaccination) * All patients who are having sex that can lead to pregnancy must agree to contraception for the duration of study Exclusion Criteria: * Patients with any of the following cardiac conditions: * Symptomatic restrictive cardiomyopathy * Unstable angina within 4 months prior to enrollment * New York Heart Association functional class III-IV heart failure on active treatment * Symptomatic pericardial effusion * Patients at risk for gastrointestinal bleeding (example: peptic ulcer disease, prolonged daily non-steroidal anti-inflammatory use) * Patients with any seizure disorder * Patients with any contraindication to receiving rhuGM-CSF based products * Patients with any clinically significant autoimmune disease uncontrolled with treatment * Patients who are simultaneously enrolled in any other treatment study * Patients who are pregnant or breastfeeding
Randomized Controlled Trial Evaluating the Role of Exercise in Women Undergoing Treatment for Breast Cancer
NCT02161900
Active, positions filled
Conditions Non Metastatic Operable Breast Cancer
Phase NA
Enrollment 850
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Yogic and routine exercises

Primary Outcomes

  • Disease-free survival
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2010-11-12
Completion: 2025-04-30
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 850 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Tata Memorial Hospital
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Yogic and routine exercises
Study Locations (1 sites)
Tata Memorial Hospital, Mumbai, Maharashtra 400012 India
Eligibility Criteria
Inclusion Criteria: * Women with unilateral breast cancer * Age 18-65 years Exclusion Criteria: * Metastatic breast cancer * Pregnant Women * Women with physical limitations to perform exercises * Previous history of cancer
Ketamine Alcohol (in Treatment-Resistant Depression)
NCT02122562
Recruiting
Conditions Magnetic Resonance Imaging, Major Depres...
Phase PHASE2
Enrollment 60
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Ketamine

Primary Outcomes

  • Montgomery-Åsberg Depression Rating Scale (MADRS)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2014-04-23
Completion: 2028-09
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 60 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Mark Niciu
Collaborators: National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigators:
  • Mark J Niciu, M.D. Ph.D. (PRINCIPAL_INVESTIGATOR) - University of Iowa Health Care (UIHC)
Contact Information
Study Contact:
Osura R Amarajeewa, M.B.B.S.
(319)-353-8536
osura-amarajeewa@uiowa.edu
Mark J Niciu, M.D. Ph.D.
(319)-594-8687
mark-niciu@uiowa.edu
Interventions
  • Ketamine
Study Locations (1 sites)
University of Iowa Health Care, Iowa City, Iowa 52242 United States
Eligibility Criteria
INCLUSION CRITERIA: 1. 18 to 55 years of age. 2. A level of understanding sufficient to agree to all required tests and examinations, sign an informed consent document and verify understanding by a score greater than or equal to 90% on the consent quiz. 3. Diagnostic and Statistical Manual-4th Edition-Text Revision (DSM-IV-TR)) diagnosis of major depressive disorder (MDD), single-episode (296.30) or recurrent (296.20) without psychotic features based on clinical assessment and confirmed by a Structured Clinical Interview for the DSM-IV- Patient Version (SCID-P). Subjects must be experiencing a current major depressive episode of at least 2 weeks duration. 4. Past failure of greater than or equal to one standard antidepressant trial based on the Antidepressant Treatment History Form (ATHF). 5. MADRS score greater than or equal to 20 at baseline and the day of ketamine infusion. EXCLUSION CRITERIA: 1. Inadequate knowledge of family mental and substance use history, e.g. adoption. 2. Current psychotic features or prior diagnosis of a DSM-IV-TR psychotic spectrum disorder, e.g. schizophrenia, schizoaffective disorder, bipolar I disorder with psychotic features, MDD with psychotic features, or bipolar disorder, e.g. bipolar I disorder without psychotic features, bipolar II disorder and bipolar disorder not otherwise specified (NOS). 3. Current/active DSM-IV-TR substance use disorder (except for caffeine or nicotine dependence). 4. Pregnant or nursing women or women of childbearing potential not using at least one medically accepted means of contraception (to include oral, injectable, or implant birth control, condom or diaphragm with spermicide, intrauterine devices (IUD), tubal ligation, abstinence or partner with vasectomy). 5. Serious, unstable medical conditions/problems including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease, e.g. uncontrolled asthma, uncontrolled hyper/hypothyroidism or active cancer. 6. Presence of any medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications. 7. Clinically significant abnormal laboratory tests. 8. Subjects with one or more seizures without clear and resolved etiology and head injury with loss of consciousness for \> 5 minutes or requiring hospitalization. 9. Treatment with psychiatric medications, e.g. selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, benzodiazepines and antipsychotics, at least two weeks of study phase II. 10. Treatment with fluoxetine within 5 weeks of study phase II. 11. Treatment with device-based treatment for depression, e.g. electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS) and vagal nerve stimulation (VNS), within 4 weeks of study phase II. 12. Lifetime history of deep brain stimulation. 13. Treatment with any disallowed concomitant medications. 14. Positive HIV test 15. Presence of ferromagnetic implants, e.g, heart pacemaker or aneurysm clip, or other contraindications to magnetic resonance imaging (MRI), e.g. claustrophobia or hearing loss. 16. Clinically-significant anatomical brain abnormalities detected on routine brain MRI. 17. Subjects who, in the investigator's judgment, pose a current serious suicidal or homicidal risk, or who have a MADRS item 10 score of greater than or equal to 4. 18. A current NIMH employee/staff or their immediate family member (N.B. former exclusion criteria likely to be no longer relevant at the University of Iowa Health Care). 19. Currently engaged in an evidence-based structured psychotherapy for mood and/or anxiety disorders, e.g. cognitive-behavioral therapy (CBT) or interpersonal psychotherapy (IPT). Additionally, the investigators may exclude or terminate any patient for clinical reasons.
Prevention of Symptomatic Skeletal Events With Denosumab Administered Every 4 Weeks Versus Every 12 Weeks
NCT02051218
Active, positions filled
Conditions Metastatic Breast Cancer, Metastatic Pro...
Phase PHASE3
Enrollment 1380
Locations 50 sites
Compensation Phase 3: Typically $200-$1,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Denosumab (reduced dosing)
  • Denosumab (standard dosing)

Primary Outcomes

  • Time to first on-trial symptomatic skeletal event (SSE; Clinically significant pathological fracture, radiation therapy to bone, surgery to bone or spinal cord compression).
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Active, positions filled
Start Date: 2014-07-16
Completion: 2028-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 1380 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Swiss Cancer Institute
Principal Investigators:
  • Roger von Moos, PD MD (STUDY_CHAIR) - Kantonsspital Graubünden
  • Arnoud Templeton, MD (STUDY_CHAIR) - Cantonal Hospital of St. Gallen
  • Silke Gillessen, Prof (STUDY_CHAIR) - Cantonal Hospital of St. Gallen
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Denosumab (reduced dosing)
  • Denosumab (standard dosing)
Study Locations (50 sites)
Landeskrankenhaus Feldkirch, Feldkirch, 6800 Austria
Klinikum Wels-Grieskrichen GmbH, Wels, 4600 Austria
Uniklinik Düsseldorf, Urologische Klinik, Düsseldorf, 40225 Germany
Universitätsklinikum Düsseldorf, Frauenheilkunde/Geburtshilfe, Düsseldorf, 40225 Germany
Universitätsmedizin Göttingen, Göttingen, 37075 Germany
Universitätsklinikum Schleswig-Holstein, Lübeck, 23538 Germany
Universitäts-Frauenklinik Ulm, Ulm, 89075 Germany
Hirslanden Klinik Aarau, Aarau, CH-5001 Switzerland
Kantonspital Aarau, Aarau, CH-5001 Switzerland
Kantonsspital Baden, Baden, CH-5404 Switzerland
Eligibility Criteria
Inclusion Criteria: * Patient has given written informed consent. * Histologically confirmed diagnosis of breast or prostate cancer before randomization. * Patient has metastatic breast cancer (stage IV, all subtypes allowed) or prostate cancer (stage IV) and bone metastases and is planned to receive or is receiving antineoplastic treatment. * Patients with prostate cancer must have evidence of disease progression on continuous androgen deprivation therapy (CRPC). * Patients must have ≥ 3 bone metastases (lytic or blastic or mixed). The lesions must be documented by radiological evaluation within 12 weeks before randomization (by X-Ray, CT scan, PET-CT, MRI scan or bone scintigraphy). * WHO performance status 0-2 * Age ≥ 18 years. * Corrected serum calcium ≥ 2 mmol/l and ≤ 3 mmol/l (medical treatments to obtain serum calcium levels in the normal range are allowed, as far as no denosumab is used. Maximally 1 dose of bisphosphonates in the case of hypercalcemia is allowed, if the bisphosphonate was applied at least 3 weeks before the first dose of denosumab). * Liver transaminases not more than 1.5 x ULN or not more than 3 x ULN with liver metastases. Serum total bilirubin ≤ 1.5 x ULN (≤ 2.0 x ULN in case of known Gilbert's disease) * Women are not breastfeeding. Women with child-bearing potential are using effective contraception, are not pregnant and agree not to become pregnant during participation in the trial and during the 12 months thereafter. A negative pregnancy test before inclusion (within 7 days) into the trial is required for all women with child-bearing potential. * Men agree not to father a child during participation in the trial and during 12 months thereafter. Exclusion Criteria: * Definite contraindication for denosumab (e.g. hypocalcaemia \[Albumin-corrected serum calcium \< 2.0 mmol/l\]). * History or current evidence of osteonecrosis of the jaw. * Non-healed mucosa in oral cavity (by surgery or as a side effect of any other treatment). * Jaw or dental conditions that require oral surgery or if surgery or invasive dental procedures are planned. * Prior use of denosumab for bone metastases (dose 120 mg every 4 weeks) or bisphosphonates to treat bone metastases. Patients treated with denosumab or bisphosphonates against osteopenia or osteoporosis are allowed to enter the trial if the last dose was more than 28 days before randomization. * Patients with known osteoporosis (T-score ≤ -2.5) at study entry (since fractures from osteoporosis are difficult to be discriminated from fractures through bone metastases). * Radiotherapy or surgery to the bone within the last two weeks before randomization or planned within 6 weeks after randomization. * Presence or history of CNS metastases or leptomeningeal disease. A MRI evaluation within 12 weeks before randomization must be performed in case of suspicious symptoms. * Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent, filling out QoL forms. * Concurrent treatment in a clinical trial with SSE or SRE as primary endpoint. * Known hypersensitivity to trial drug or hypersensitivity to any other component of the trial drug (e.g. fructose). * Any concomitant drugs contraindicated for use with the trial drugs according to the approved product information. * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the trial protocol.
Physical Activity Program for Reducing Blood Pressure in Sleep Apnea Patients With Resistant Hypertension
NCT02057783
Recruiting
Conditions Hypertension, Resistant to Conventional ...
Phase NA
Enrollment 100
Locations 5 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Physical activity

Primary Outcomes

  • Systolic arterial blood pressure assessed by 24-hours home blood pressure monitoring
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2015-03-26
Completion: 2025-02-18
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 100 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: AGIR à Dom
Collaborators: University Hospital, Grenoble
Principal Investigators:
  • Jean-Louis Pépin, Pr MD PhD (PRINCIPAL_INVESTIGATOR) - Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France
Contact Information
Study Contact:
Jean-Louis Pépin, Pr MD PhD
JPepin@chu-grenoble.fr
Sandrine Bouzon
sbouzon@chu-grenoble.fr
Interventions
  • Physical activity
Study Locations (5 sites)
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ), Québec, Canada
Hopital Universitaire de Grenoble, La Tronche, 38700 France
Clinique Pasteur, Toulouse, 31300 France
Hopitaux Universitaires de Genève, Geneva, Switzerland
Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland
Eligibility Criteria
Inclusion Criteria: * Patient with an obstructive sleep apnea (apnea-hypopnea index \> or equal to 15) * Patient with resistant hypertension uncontrolled by 3 or more antihypertensive agents * Ambulatory patient Exclusion Criteria: * Acute hepatic failure, biliary cirrhosis, cholestasis * Acute hypertension (SBP\>= 180 mmHg and/or DBP \>= 110 mmHg) * Contraindication to CPAP treatment
Evaluation of Objective Perimetry Using Chromatic Multifocal Pupillometer
NCT02014389
Recruiting
Conditions Retinal Dystrophies, Retinitis Pigmentos...
Phase Not Applicable
Enrollment 200
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Primary Outcomes

  • PLR response amplitude and latency
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2013-12-01
Completion: 2026-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 200 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Sheba Medical Center
Contact Information
Study Contact:
Ygal Rotenstreich, MD
972547898137
Ygal.Rotenstreich@sheba.health.gov.il
Interventions
N/A
Study Locations (1 sites)
Sheba Medical Center, Tel Litwinsky, 52621 Israel
Eligibility Criteria
Inclusion Criteria: * Age 18-80 years old. * Signing informed consent. * Pupillary reflex to light. Exclusion Criteria: 1. Cloudy corneas. 2. Surgical intraocular ophthalmic procedure within the past 30 days. 3. No reactive pupils. 4. Synechia of the iris to the lens after surgery or inflammation. 5. Neovascularization. 6. Axenfeld-Rieger Syndrome. 7. Iris atrophy (ICE syndrome). 8. Iris coloboma. 9. Sphincter damage due to ischemia. 10. Sphincter damage due to trauma (tears of sphincter or diffuse damage to muscle). 11. Sphincter damage due to Herpes Zoster Uveitis. 12. Sphincter damage due to high intraocular pressure. 13. Iris tumor or cyst. 14. Ectropion uvae. 15. Adie's pupil. 16. Third nerve aberrant regeneration of the iris sphincter. 17. RP patients with Optic neuropathy with the potential of producing a positive RAPD (Relative Afferent Pupillary Defect). 18. Chronic use of myotics or mydriatics. 19. Systemic medication that have affect on pupillary reflex . 20. Any condition preventing accurate measurement or examination of the pupil.
Cirrhosis, Effects of TRAnsplantation and Diabetes
NCT02038517
Recruiting
Conditions Liver Cirrhosis
Phase Not Applicable
Enrollment 200
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Primary Outcomes

  • Relationship of insulin secretion and sensitivity with the development of abnormalities of glucose metabolism after OLT
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2013-06
Completion: 2026-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 200 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Principal Investigators:
  • Emanuela Orsi, MD (PRINCIPAL_INVESTIGATOR) - Endocrinology and Diabetes Unit, Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, Milan, Italy
Contact Information
Study Contact:
Emanuela Orsi, MD
+390255034590
e.orsi@policlinico.mi.it
Interventions
N/A
Study Locations (1 sites)
Endocrinology and Diabetes Unit, Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, Milan, MI 20122 Italy
Eligibility Criteria
Inclusion Criteria: Subjects with end-stage liver cirrhosis in waiting list for orthotopic liver transplantation at the Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, Milan, Italy Exclusion Criteria: * Known diabetes * Cystic fibrosis * Pregnancy
REVIVE: Replens Versus Intra-Vaginal Estrogen for the Treatment of Vaginal Dryness on Aromatase Inhibitor Therapy
NCT01984138
Active, positions filled
Conditions Estrogen Receptor Positive Breast Cancer...
Phase PHASE2
Enrollment 33
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • ESTRING
  • Replens
  • Vagifem

Primary Outcomes

  • What is the number of participants that show improvement of symptoms using vaginal estrogen as compared to the control.
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Active, positions filled
Start Date: 2013-09
Completion: 2026-06
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 33 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Polly A. Niravath, MD
Principal Investigators:
  • Polly Niravath, MD (PRINCIPAL_INVESTIGATOR) - Houston Methodist Cancer Center
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • ESTRING
  • Replens
  • Vagifem
Study Locations (1 sites)
Houston Methodist Cancer Center, Houston, Texas 77030 United States
Eligibility Criteria
Inclusion Criteria: 1. be female 2. be 18 years of age or older. 3. have stage I-III ER+ breast cancer 4. be post-menopausal as defined by any of the following: age \>55 years, history of bilateral oophorectomy, amenorrhea for 1 year with intact uterus and ovaries, or serum estradiol and FSH concentrations in the post-menopausal range along with either amenorrhea for 6 months or previous hysterectomy. 5. currently take adjuvant AI therapy 6. have vaginal dryness, dyspareunia, or ≥3 urinary tract infections per year since starting AI therapy 7. Patients must agree not to use any additional estrogen during the five year study period. However, use of non-estrogen containing lubricants prior to sexual intercourse, or otherwise, is allowed. Exclusion Criteria: 1. use of any exogenous estrogen within the preceding four weeks 2. current vaginal infection.
Deep Brain Stimulation for Treatment Resistant Depression With the Medtronic Activa PC+S
NCT01984710
Active, positions filled
Conditions Treatment Resistant Depression
Phase NA
Enrollment 10
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Medtronic Activa PC+S System

Primary Outcomes

  • Changes in Activa PC+S Local Field Potential (LFP) Recordings
  • Change in Hamilton Depression Rating Scale-17 Score
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2013-09
Completion: 2029-01
Eligibility
Age: 25 Years
Sex: ALL
Volunteers: false
Enrollment: 10 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Emory University
Collaborators: Hope for Depression Research Foundation, The Dana Foundation, National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigators:
  • Patricio Riva Posse, MD (PRINCIPAL_INVESTIGATOR) - Emory University
  • Helen Mayberg, MD (PRINCIPAL_INVESTIGATOR) - Emory University and Mount Sinai
  • Christopher Rozell, PhD (PRINCIPAL_INVESTIGATOR) - Georgia Institute of Technology
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Medtronic Activa PC+S System
Study Locations (1 sites)
Emory University, Atlanta, Georgia 30322 United States
Eligibility Criteria
Inclusion Criteria: * Ability to provide written informed consent. * Agrees to relocate to the Atlanta Metro region for the duration of the acute phase of the investigation (approximately 8-10 months) and to return regularly for clinical and research assessments * Current Major Depressive Episode (MDE), either Major Depressive Disorder single episode or recurrent type * Current depressive episode of at least two years duration or a history of more than 4 lifetime depressive episodes * Minimum score at study entry of 20 on the 17-item Hamilton Depression Rating Scale (HDRS-17) * Average pre-operative HDRS-17 score of 20 or greater (averaged over four weekly pre-surgical evaluations during the four weeks prior to surgery) and an average pre-operative HDRS-17 score no more than 30% lower than the baseline screening HDRS-17 score * A maximum Global Assessment of Functioning of 50 or less * Failure to respond to a minimum of four different antidepressant treatments, including at least three medications from at least three different drug classes, evidence-based psychotherapy or electroconvulsive therapy (ECT) administered at adequate doses and duration during the current episode * Failure or intolerance of an adequate course of electroconvulsive therapy (ECT) during any episode * On stable antidepressant medication * Have an established outpatient psychiatrist and be willing to sign a written release to allow study investigators to give and receive information from this psychiatrist Exclusion Criteria: * Inability/ refusal to sign written informed consent * Refusal or inability to relocate to Atlanta Metro region for acute phase of protocol or to return for regular assessments in long term follow up * Inability to tolerate general anesthesia * Significant cerebrovascular risk factors or a previous stroke, documented major head trauma or neurological disorder * Other currently active clinically significant Axis I psychiatric diagnosis including bipolar disorder, schizophrenia, panic disorder, obsessive-compulsive disorder, generalized anxiety disorder or post-traumatic stress disorder * Current psychotic symptoms * Evidence of global cognitive impairment * Substance abuse or dependence not in full, sustained remission * Active suicidal ideation with intent; suicide attempt within the last six months; more than three suicide attempts within the last two years * Pregnancy or plan to become pregnant during the study period * General contraindications for DBS surgery (cardiac pacemaker/defibrillator or other implanted devices) * Inability or unwillingness to comply with long-term follow-up * History of intolerance to neural stimulation of any area of the body * Participation in another drug, device or biologics trial within the preceding 30 days prior to initial screening * Conditions requiring repeated MRI scans * Conditions requiring diathermy * Conditions requiring anticoagulant medication * Terminal illness associated with expected survival of \<12 months
Neoadjuvant Chemotherapy in HER2 Positive Breast Cancer, TRAIN-2
NCT01996267
Active, positions filled
Conditions Breast Cancer, HER2 Positive
Phase PHASE3
Enrollment 437
Locations 33 sites
Compensation Phase 3: Typically $200-$1,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • PTC+Pertuzumab
  • FEC-T+Pertuzumab

Primary Outcomes

  • Number of patients with pathological complete response
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Active, positions filled
Start Date: 2013-12
Completion: 2030-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 437 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: The Netherlands Cancer Institute
Collaborators: Roche Pharma AG, Borstkanker Onderzoek Groep
Principal Investigators:
  • Gabe S Sonke, MD (PRINCIPAL_INVESTIGATOR) - Antoni van Leeuwenhoek, Amsterdam
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • PTC+Pertuzumab
  • FEC-T+Pertuzumab
Study Locations (33 sites)
Jeroen Bosch Hospital, 's-Hertogenbosch, Netherlands
MCA, Alkmaar, 1815 JD Netherlands
ZGT, Almelo, 7609 PP Netherlands
Antoni van Leeuwenhoek, Amsterdam, 1066 CX Netherlands
AZVU, Amsterdam, 1081 HV Netherlands
OLVG, Amsterdam, 1090 HM Netherlands
Rode Kruis Ziekenhuis, Beverwijk, 1940 EB Netherlands
Amphia ziekenhuis, Breda, 4819 EV Netherlands
Reinier de Graaf Groep, Delft, 2625 AD Netherlands
Deventer ziekenhuis, Deventer, 7416 SE Netherlands
Eligibility Criteria
Inclusion Criteria: * Histologically confirmed infiltrating breast cancer * Stage II or stage III disease. Nodal status must be examined by ultrasound, fine needle aspiration, sentinel node biopsy, or FDG-PET scan. * Overexpression and/or amplification of HER2 in an invasive component of the core biopsy, according to one of the following definitions: •\>30% of invasive tumor cells showing strong complete circumferential membrane staining (score 3+) •HER2 gene amplification defined as \>6 HER2 gene copies per nucleus by in situ hybridization. * Age ≥18 * Eastern Cooperative Oncology Group performance status ≤1 * Adequate bone marrow function (ANC \>1.5 x 109/l, platelets \>100 x 109/l) * Adequate hepatic function (ALAT, ASAT and bilirubin \<2.5 times upper limit of normal) * Adequate renal function (creatinine clearance \>50 ml/min) * LVEF ≥50% measured by echocardiography or MUGA * Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * Absence of any medical condition that would place the patient at unusual risk. * Signed written informed consent Exclusion Criteria: * previous radiation therapy or chemotherapy * other malignancy except carcinoma in situ, unless the other malignancy was treated ≥5 years ago with curative intent without the use of chemotherapy or radiation therapy. * current pregnancy or breastfeeding. Women of childbearing potential must use adequate contraceptive protection * evidence of distant metastases. Evaluation of the presence of distant metastases may include chest X-ray, liver ultrasound, isotope bone-scan, CT-scan of chest and abdomen and/or FDG-PET scan, according to local procedures. * evidence of bilateral infiltrating breast cancer. Evaluation of the presence of bilateral infiltrating breast cancer may include mammography, breast ultrasound and/or MRI breast. * concurrent anti-cancer treatment or another investigational drug.