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About This Study

The Nanosomal Docetaxel Lipid Suspension (NDLS) consists of uniformly sized micro particles of docetaxel suspended in a lipid based formulation. The advantage of such a Lipid Based formulation of Docetaxel is an improvement of the safety profile by eliminating excipients, polysorbate 80 and ethanol which are present in conventional Docetaxel formulations (Taxotere®). This randomized, open-label study is designed to assess the efficacy and safety of Nanosomal Docetaxel Lipid Suspension at the dose of 75 mg/m2 and at the dose of 100 mg/m2 compared to Taxotere® at the dose of 100 mg/m2 in triple-negative breast cancer patients with Locally Advanced or Metastatic Breast Cancer. Patients will continue the treatment in the absence of disease progression and unacceptable toxicity. Disease status and tumor response will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) guidelines. 657 patients (219 patients per arm) will be randomized in the study. The trial will be conducted as per the ICH GCP Guidelines E6 (R1), Schedule Y (Amended Version 2013), Declaration of Helsinki (Fortaleza, Brazil, October 2013), ICMR Guidelines for Biomedical Research on Human subjects and in accordance with other applicable guidelines.

Design

Interventions / Regimen

• Drug: Nanosomal Docetaxel Lipid Suspension (75 mg/m2) — Each vial containing lyophilized Docetaxel lipid powder, equivalent to 20 mg or 80 mg of anhydrous Docetaxel.
• Drug: Nanosomal Docetaxel Lipid Suspension (100 mg/m2) — Each vial containing lyophilized Docetaxel lipid powder, equivalent to 20 mg or 80 mg of anhydrous Docetaxel.
• Drug: Taxotere® (100 mg/m2) — Docetaxel Injection Concentrate; 20 mg/0.5 mL

Primary Outcomes

• Proportion of the patients with Objective Response Rate (i.e., CR + PR) as the Best Overall Response Rate (i.e., CR + PR) in the test arm (NDLS) compared to reference arm (Taxotere) (Approximately 2 years after study initiation)

About This Study

The primary objective of this study is to describe the rate of local control in patients with her-2 positive early stage breast cancer with a complete response to chemotherapy and lumpectomy alone.

Design

Interventions / Regimen

• Radiation: Omission of Radiation — No Radiation will be given. 1 year of trastuzumab +/- pertuzumab treatment will be given with 5 years of follow up occurring every 3 months to check for recurrence

Primary Outcomes

• Ipsilateral Breast Cancer Recurrence (up to 5 year post-op)

About This Study

This Phase III trial compares the recurrence-free interval (RFI) among patients with early-stage, low risk HER2+ breast cancer who undergo breast conserving surgery and receive HER2-directed therapy, and are randomized to not receive adjuvant breast radiotherapy versus those who are randomized to receive adjuvant radiotherapy per the standard of care.

Design

Interventions / Regimen

• Radiation: Standard of Care Adjuvant Breast Radiation — adjuvant breast radiotherapy per the current standard of care
• Drug: Standard of Care HER2-targeted Therapy Without Adjuvant Breast Radiation — participants are randomized to continue their standard of care systemic HER2-targeted therapy without adjuvant breast radiotherapy

Primary Outcomes

• recurrence-free interval (RFI) (From randomization to first recurrence event or censoring for the duration of the trial, at 10.5 years)

About This Study

Differential immunogenomic signatures from peripheral blood CD14 (phagocytic) and CD2 (non-phagocytic) cells have been associated with multiple cancers and disease states. In particular several large clinical studies at Immunis.AI have demonstrated robust immunogenomic signatures in early-stage prostate cancer. Immunis.AI therefore hypothesizes that a peripheral blood immunogenomic signature will identify patients with various stages of breast cancer from healthy negative controls.

Design

Interventions / Regimen

• Diagnostic Test: Blood test — Proprietary immunogenomic signature from peripheral blood CD14 and CD2 cells.

Primary Outcomes

• Primary Aim (12 months)

About This Study

This randomized research trial studies how well serum tumor marker directed disease monitoring works in monitoring patients with hormone receptor positive Her2 negative breast cancer that has spread to other places in the body. Using markers to prompt when scans should be ordered may be as good as the usual approach to monitoring disease.

Design

Interventions / Regimen

• Other: Usual care disease monitoring — Imaging and serum tumor markers are at the discretion of the treating physician (however imaging must be performed at least every 12 weeks).
• Other: Serum Tumor Marker directed disease monitoring — Serum tumor markers every 4-8 weeks without imaging
• Other: Quality-of-Life Assessment — Ancillary studies
• Other: Anxiety Questionnaire Administration — Ancillary studies

Primary Outcomes

• Assessment of whether patients monitored with STMDDM have non-inferior overall survival compared with patients monitored with usual care (Up to 312 weeks after randomization)

About This Study

This clinical trial compares a physical activity program to a health education program for improving memory and attention in Hispanic women who are 50 years of age or older and are newly-diagnosed with stage I-IIIa breast cancer. Compared to non-Hispanic White breast cancer survivors (BCS), Hispanic BCS report greater depressive symptoms, emotional distress, anxiety, fear of recurrence, pain, fatigue, and financial toxicity, in addition to more cancer-related psychosocial needs and lower quality of life and social well-being. Cancer-associated cognitive decline (CACD) is a related symptom that has gained increasing attention in clinical research. Based on disparities in other outcomes, it is likely that Hispanic BCS also experience greater CACD than non-Hispanic White BCS, but interventions targeting CACD in Hispanic BCS are non-existent and critically needed. The benefits of aerobic exercise among BCS are well documented and include improvement in health outcomes that are associated with cognitive function including fatigue, anxiety, depression, and sleep. A physical activity program that includes aerobic exercise may be more effective than simple health education for improving cognitive functions like memory and attention in Hispanic women who are 50 years of age or older and are newly-diagnosed with stage I-IIIa breast cancer.

Design

Interventions / Regimen

• Procedure: Accelerometry — Ancillary studies
• Other: Aerobic Exercise — Participate in walking program
• Other: Electronic Health Record Review — Ancillary studies
• Procedure: Functional Magnetic Resonance Imaging — Undergo fMRI
• Other: Gait Assessment Test — Ancillary studies
• Behavioral: Health Education — Receive health education
• Other: Interview — Ancillary studies
• Other: Neurocognitive Assessment — Ancillary studies

Primary Outcomes

• Change in inhibitory control (Baseline to post-intervention (month 6))
• Change in cognitive flexibility (Baseline to post-intervention (month 6))
• Change in executive function processing (Baseline to post-intervention (month 6))
• Change in short-term memory (Baseline to post-intervention (month 6))
• Change in verbal memory (Baseline to post-intervention (month 6))
• Change in working memory (Baseline to post-intervention (month 6))
• Change in processing speed (Baseline to post-intervention (month 6))
• Change in attention (Baseline to post-intervention (month 6))

About This Study

This study is being done to evaluate cosmetic, patient-reported outcome measures (PROMs), and toxicities for women undergoing ultra-short whole breast irradiation (WBI) therapy with simultaneous integrated boost (SIB). 50 participants will be on study for up to 60 months.

Design

Interventions / Regimen

• Radiation: Radiation Therapy — WBI with SIB delivered over 5 fractions

Primary Outcomes

• Harvard Breast Cosmesis Scale Score (up to 2 years post-treatment (treatment ends up to 5 weeks on study))

About This Study

The Breast Cancer Program Longitudinal Repository (BCPLR) is being established to fulfill the research mission of the Breast Cancer Program at Johns Hopkins and to serve investigators affiliated with it - to develop a repository of specimens with corresponding characteristics from patients seen in the breast care and cancer clinics.

Design

Interventions / Regimen

• Procedure: Sample collection — Blood, tissue, urine, and other samples may be collected

Primary Outcomes

• Repository development (20 years)

About This Study

To determine the efficacy of a multicomponent adherence intervention among participants with early-stage breast cancer on endocrine therapy and at least one oral cardiovascular disease (CVD) medication on adherence to endocrine therapy and to CVD medication at 24 weeks assessed by self-report using the Domains of Subjective Extent (DOSE)-Nonadherence questionnaire and also by pharmacy fill data assessed in the electronic health record (EHR).

Design

Interventions / Regimen

• Behavioral: Multicomponent Adherence Intervention — The adherence intervention will be comprised of a participant preference approach in which all participants undergo a baseline pharmacist-led medication optimization session and are offered training in how to use the patient portal and freely-available smartphone reminder app.
• Other: Usual Care — Receipt of usual care from providers

Primary Outcomes

• Number of Participants Adherent to Endocrine Therapy (ET) and CVD Medication at 24 Weeks (24 Weeks)

About This Study

Triple-negative breast cancer (TNBC) accounts for about 20% of clinical breast cancer. Clinical characteristics include early onset, high malignancy and heterogeneity. There is no effective drug target for TNBC, resulting in poor outcomes, high relapse rate and distant metastasis. So, further research on TNBC pathological features is particularly important. Compared with the solvent-based paclitaxel, albumin-bound paclitaxel (nab-P) demonstrates a stronger therapeutic effect. With albumin nanoparticles as a carrier, nab-P increases the concentration of extra-tumor drugs by passing through the albumin receptor (Gp60) transmembrane pathway and the secreted protein acidic and rich in cysteine (SPARC) approach that binds to the extracellular matrix of the tumor. Numerous clinical trials have found that nab-P is superior to the solvent-based paclitaxel in the treatment of breast cancer, especially in breast cancer with poor prognosis. However, the current efficacy of nab-P in the treatment of TNBC has not been fully verified. The mechanism underlying the killing effect of nab-P on TNBC breast cancer cells remains unclear yet. This trial will compare the therapeutic effect of nab-P with solvent-based paclitaxel in TNBC patients, and seek for important scientific clues, scientific evidence, and clinical data for nab-P in the treatment of TNBC.

Design

Interventions / Regimen

• Drug: nab-Paclitaxel+carboplatin — Nab-P (Abraxis BioScience, LLC., Mclrose Park, IL, USA; drug license No. H20091059), 125 mg/m2, intravenous drip for 30 minutes once, on days 1 and 8, 21 days as a session for a total of 6 sessions; at the same time, carboplatin (Qilu Pharmaceutical Co., Ltd., Jinan, Shandong Province, China; drug license No. Guoji Zhunzi H20020181), AUC=2 mg•min/mL, intravenous drip for 120 minutes once, on days 1 and 8, 21 days as a session for a total of 6 sessions.
• Drug: Paclitaxel+carboplatin — Paclitaxel (Yangtze River Pharmaceutical Co., Ltd., Taizhou, Jiangsu Province, China; drug license No. Guoyao Zhunzi H20053001), 125 mg/m2, intravenous drip for 30 minutes once, on days 1 and 8, 21 days as a session for a total of 6 sessions; at the same time, carboplatin, AUC=2 mg•min/mL, intravenous infusion for 120 minutes once, on days 1 and 8, 21 days as a session for a total of 6 sessions.

Primary Outcomes

• Pathologic complete response (PCR) (At 5 years of treatment)

About This Study

Hot flashes are among the most common and distressing adverse effects experienced by patients receiving endocrine therapy for hormone receptor-positive breast cancer. Hormone replacement therapy (HRT) and non-hormonal medications can alleviate symptoms but are limited by side effects and safety concerns, leading to poor adherence. Acupuncture, a traditional Chinese medical therapy involving percutaneous stimulation of specific acupoints, has shown potential to reduce the frequency and severity of hot flashes with minimal adverse events. This randomized, parallel-controlled clinical trial aims to evaluate the efficacy and safety of acupuncture in managing hot flashes in postoperative breast cancer patients undergoing endocrine therapy. Sixty eligible patients with stage I-III hormone receptor-positive breast cancer will be randomly assigned in a 1:1 ratio to receive either true acupuncture or sham acupuncture, three times per week for eight weeks, followed by a 16-week follow-up period without acupuncture. Functional magnetic resonance imaging (fMRI) will be employed to explore neural mechanisms underlying acupuncture's effects, alongside assessments of hot flash frequency, quality of life (FACT-B+ES), sleep quality (PSQI), and serum biomarkers related to endocrine and neuropeptide regulation. The results are expected to provide evidence for the efficacy and central mechanisms of acupuncture in managing hot flashes in breast cancer patients.

Design

Interventions / Regimen

• Other: True Acupuncture — Acupoints: Sanyinjiao (SP6), Taixi (KI3), Taichong (LR3), Zusanli (ST36) Frequency: 3 sessions per week, for 8 consecutive weeks (24 sessions total) Procedure: Needles inserted to a depth of 0.5 cun, electrical stimulation at 2 Hz, even reinforcing-reducing manipulation until "Deqi" sensation achieved; needles retained for 30 minutes.
• Other: Sham Acupuncture — Points: Non-meridian, non-acupoint sites located 0.5-1 cm lateral to true points Frequency: 3 sessions per week, for 8 consecutive weeks Procedure: Needles inserted superficially (0.2 cun) without manipulation or "Deqi" sensation; 2 Hz electrical stimulation applied for 30 minutes.

Primary Outcomes

• Cranial fMRI Imaging Evaluation and Data Analysis (4 months)

About This Study

RADIOSPHER2 study is a monocentric, retrospective, observational study aiming at identifying a radiomics signature able to predict HER2 expression (0 vs low vs overexpression) and trastuzumab deruxtecan efficacy in metastatic breast cancer patients. The study also encompasses translational analyses and inter-modal correlations in order to provide novel insights about HER2 spatial and temporal heterogeneity, at the macroscopic and microscopic levels.

Design

Interventions / Regimen

• Drug: Trastuzumab deruxtecan (DS-8201a) — A subgroup of the study cohort treated with Trastuzumab Deruxtecan in the metastatic setting

Primary Outcomes

• HER2 protein expression (Time of the metastatic biopsy (through study completion, an average of 1 year))
• Progression-Free Survival (From treatment start to disease progression or death (through study completion, up to 5 years))

About This Study

The purpose of this study is to provide post-trial access to alpelisib and to assess its long-term safety when administered as a single agent or in combination with other drugs. This study is intended for participants who are currently receiving alpelisib in a Novartis-sponsored clinical trial (parent study) and, in the Investigator's judgment, would benefit from continued treatment with alpelisib.

Design

Interventions / Regimen

• Drug: Alpelisib — Administered as oral tablets at dose levels as per the parent study, taken once daily.
• Drug: Fulvestrant — Administered as an intramuscular injection at dose levels and dosing schedule as per standard of care, in accordance with the parent study.
• Drug: Trastuzumab — Administered as an intravenous infusion of a reconstituted lyophilized powder at dose levels as per the parent study, given every 21 days.
• Drug: Pertuzumab — Administered as an intravenous infusion of a solution concentrate at dose levels as per the parent study, given every 21 days.
• Drug: Letrozole — Administered as oral tablets at a dose of 2.5 mg, taken once daily, as per the parent study.

Primary Outcomes

• Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) (From start of treatment up to 30 days after last dose of study treatment, assessed up to approximately 53 months)

About This Study

The ANTARES study is a phase II basket trial designed to evaluate the tissue-agnostic efficacy of the monoclonal anti-PD1 antibody, nivolumab, in patients with advanced or metastatic rare tumors. The study aims to treat rare malignancies with PD-L1 expression (CPS ≥ 10), regardless of the tumor's tissue type or location. Patients who have not responded to standard treatments will be included, and treatment will last for up to 12 months. The study will assess objective response, progression-free survival, and biomarkers such as PD-L1, ctDNA, and microvesicles, in a multicenter collaborative effort to provide innovative therapeutic options for this underrepresented population

Design

Interventions / Regimen

• Drug: Nivolumab — The intervention consists of administering Nivolumab 480 mg intravenously every 4 weeks, with a +5 day window for postponement but not for advancement of treatment. Treatment will continue until limiting toxicity, disease progression, or for a maximum period of 12 months (13 cycles) as maintenance therapy, provided the patient maintains stable disease, a partial response, or a complete response. Patients who are off treatment for more than 56 days (2 cycles) due to Nivolumab-related toxicities or other clinical issues will be discontinued from the protocol. After 12 months of treatment or in the event of study discontinuation for any reason, patients will be followed by the research team via telephone every 60 days, with a +/- 7 day window, until death.

Primary Outcomes

• Primary Objective (2 years)
• Primary Endpoint (2 years)

About This Study

A multicentre prospective cohort study will monitor the efficacy and safety of Autologous Fat Transfer (AFT) with pre-expansion. AFT will be evaluated in terms of quality of life, aesthetic result, complications, oncological safety and cost-effectiveness. It follows the BREAST trial, the randomised controlled trial comparing AFT with implant-based reconstruction. In this study, patients all receive AFT.

Design

Interventions / Regimen

• Procedure: Autologous Fat Transfer — Female breast cancer patients who were surgically treated with mastectomy could opt for a full breast reconstruction with Autologous Fat Transfer in combination with external expansion.

Primary Outcomes

• Breast-related Quality of life (2 years)

About This Study

This randomized clinical trial compares two systemic treatments for HER2-positive breast cancer. The treatments are given either prior to breast surgery (as neoadjuvant treatment) or after breast surgery (as adjuvant treatment). In the investigational group (Group A) the study participants will receive a combination of two drugs directed at HER2 (two anti-HER2 antibodies) plus a chemotherapy agent (docetaxel) for a brief duration, and the patients allocated to the comparator group (Group B) will be treated with chemotherapy plus one anti-HER2 treatment (trastuzumab) for one year.

Design

Interventions / Regimen

• Drug: Pertuzumab — Pertuzumab 420 mg i.v. 3-weekly for 3 cycles
• Drug: Trastuzumab — Trastuzumab 6 mg/kg, i.v., 3-weekly for for a total duration of one year

Primary Outcomes

• Invasive disease-free survival (7 years)

About This Study

This randomized controlled trial aims to evaluate the effects of pranayama and pursed-lip breathing exercises on postoperative pain, anxiety, and vital signs in patients undergoing breast surgery. Postoperative pain and anxiety are common problems that can negatively affect recovery, physiological stability, and overall well-being. Non-pharmacological interventions such as breathing exercises may help reduce these adverse outcomes and support recovery. Participants will be randomly assigned to one of three groups: a pranayama breathing exercise group, a pursed-lip breathing exercise group, or a control group receiving routine postoperative care. Breathing exercises will be performed three times daily for five minutes. Outcomes including pain, anxiety, and vital signs will be measured at baseline (pretest), postoperative day 1, and postoperative day 2. The findings of this study are expected to provide evidence on the effectiveness of breathing exercises as supportive nursing interventions in the postoperative care of breast surgery patients.

Design

Interventions / Regimen

• Behavioral: Pranayama Breathing Exercise — Participants perform pranayama breathing exercises (Nadi Shodhana technique) starting at the 4th postoperative hour. The exercise is performed three times daily for two consecutive days. Each session lasts approximately five minutes and is administered in addition to routine postoperative care. The breathing technique involves slow, controlled inhalation and exhalation through alternate nostrils to improve respiratory function and relaxation.
• Behavioral: Pursed-Lip Breathing Exercise — Participants perform pursed-lip breathing exercises starting at the 4th postoperative hour. The exercise is performed three times daily for two consecutive days, with each session lasting approximately five minutes. Participants inhale slowly through the nose and exhale through pursed lips to prolong exhalation and improve ventilation, in addition to routine postoperative care.

Primary Outcomes

• Postoperative Pain Level (Postoperative day 1, and postoperative day 2.)

About This Study

The primary objectives of this study are as follows: Phase 1 (sequential dose-escalation): to evaluate the safety and tolerability of sacituzumab govitecan-hziy (SG) as a single agent and to determine the recommended Phase 2 dose (RP2D) of SG in Japanese participants with advance solid tumors. Phase 2: Evaluate the safety and efficacy of SG in Japanese participants with metastatic triple-negative breast cancer (mTNBC), hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC), and metastatic urothelial cancer (mUC).

Design

Interventions / Regimen

• Drug: Sacituzumab Govitecan-hziy — Administered intravenously (IV)

Primary Outcomes

• Phase 1: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) Defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 (First dose date to last dose date (Up to 15 weeks) plus 30 days)
• Phase 1: Percentage of Participants Experiencing Laboratory Abnormalities Defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 (First dose date to last dose date (Up to 15 weeks) plus 30 days)
• Phase 1: Percentage of Participants Experiencing Dose-limiting toxicity (DLTs) per Dose level (First dose date up to 21 days)
• Phase 2:(Metastatic Triple-negative Breast Cancer (mTNBC);Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2-negative Metastatic Breast Cancer (HR+/HER2- mBC) Cohorts):Objective Response Rate (ORR) as Assessed by IRC (Up to 17 months)
• Phase 2 (Metastatic Urothelial Cancer (mUC) Cohort): ORR as Assessed by Investigator (Up to 17 months)

About This Study

Several studies proved that the serratus anterior plane block(SAPB) offer analgesia not inferior or as effective to opioids which is mainstay of analgesia (chai et al., 2023). In this study we will compare the analgesic effect of the serratus anterior plane block versus a new paraspinal technique block which is the midpoint transverse process to pleura (MTP) block for postoperative analgesia after modefied radical mastectomy.

Design

Interventions / Regimen

• Procedure: Serratus Anterior Plane Block (SAPB) — Group I: (Serratus Anterior Plane Block (SAPB) Group) (n=15): The patient will lay on her side with arm brought forward, the linear US transducer probe (10-12 MHz) will be placed in the midaxillary line and then moved caudal from second rib until the sixth intercostal space. At this point, the subcutaneous tissue and serratus muscle will be identified in the superficial plane, whereas the external intercostal muscles will be identified in the intermediate plane and finally in the deep plane the ribs, pleura and lung will be identified. The needle will be advanced from caudal to cranial direction. In-plane technique will be used until the tip of the needle placed between the serratus anterior muscle and the external intercostal muscle (deep SABP) . A volume of titrated bolus of 20 ml of bupivacaine 0.5% will be injected after aspiration to avoid intravascular injection.
• Procedure: Midpoint transverse process to pleura (MTP) block — In the lateral postion, the T4 spine will be counted by ultrasound, and high frequency linear US transducer probe (10-12 MHz) will be placed longitudinally, approximately 2.5 cm lateral to the midline the needle will be advanced in plane from cranial to caudal direction. The desired end point for the needle tip will be the midpoint of the line between the posterior border of the transverse process of T4 and the pleura(injection will be deep (anterior) to the posterior aspect of the vertebral transverse process but superficial to the superior costotransverse ligment),the needle tip dose not enter the paravertebral space , a volume of titrated bolus of 20 ml of bupivacaine 0.5% will be injected after aspiration to avoid intravascular injection,pleural displacement and bowing of erector spinae will be observed at the side of injection .

Primary Outcomes

• the mean duration to require first rescue analgesia which will be (Diclofenac 75mg) when NRS pain score ≥4 at rest. (24 hours post- operative)

About This Study

This randomized Phase III study aims to show major complication rate of hypofractionation radiation therapy is not inferior, compared to conventional fractionation radiation therapy in breast cancer patients undergoing mastectomy and reconstruction surgery.

Design

Interventions / Regimen

• Radiation: Hypofractionation — Radiation regimen of 2.5-3.0Gy x 13-17 fractions +/- sequential boost 0-7 fractions
• Radiation: Conventional Fractionation — Radiation regimen of 1.8-2.0Gy x 23-28 fractions +/- sequential boost 0-5 fractions

Primary Outcomes

• Major Complication Rate (Up to 2 years after the completion of radiation therapy)
• Capsular Contracture (If implant-based recontruction is performed) (Up to 2 years after the completion of radiation therapy)