Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients With HR+/HER2- Metastatic Breast Cancer Who Have Received Endocrine Therapy
- Conditions
- ocally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer in patients who have received an endocrine-based regimenMedDRA version: 23.0Level: PTClassification code: 10083232Term: HER2 negative breast cancer Class: 100000004864MedDRA version: 23.0Level: PTClassification code: 10083234Term: Hormone receptor positive breast cancer Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2022-502593-17-00
- Lead Sponsor
- Gilead Sciences Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 648
Assigned male or female at birth, 18 years of age or older (or minimum age according to country-specific requirements), able to understand and give written informed consent., Patients must have completed any anticancer treatment at least 14 days prior to randomization. Any toxicity experienced on prior treatment must have resolved or be considered clinically stable prior to randomization., Patients with HIV must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease defined as: a) Patients on ART must have a CD4+ T-cell count at least 350 cells/mm3 at the time of screening. b) Patients on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 copies/mL or the lower limit of quantitation (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks prior to screening. c) Patients on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks prior to randomization. d) The combination ART regimen must not contain any medications that may interfere with SN-38 metabolism., Meet the organ function requirements as per study protocol section 4.2, Male patients and female patients of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception., Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1., Life expectancy of at least 3 months., Willing and able to comply with the requirements and restrictions in this protocol., Patients must have measurable disease per RECIST v1.1 criteria., Must have adequate tumor tissue sample preferably from locally recurrent or metastatic site, either in a formalin-fixed, paraffin-embedded block or newly sectioned, unstained slides for HER2 status and other biomarker assessments., Documented evidence of HR+ metastatic breast cancer (mBC) confirmed with the most recently available tumor biopsy preferably from a locally recurrent or metastatic site and defined per American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) criteria as HR+ (a tumor is considered HR+ if at least 1% of the cells examined have estrogen or progesterone receptors) by local assessment using the most recent biopsy from a non–bone lesion., Documented evidence of HER2- status according to ASCO-CAP guidelines. HER2- status including HER2 IHC0 or HER2-low (IHC 1+, IHC 2+/ISH-) should be documented by local testing at the time of eligibility review. If HER2 IHC is not locally available, central testing can be requested in discussion with the sponsor, Documented PD by computed tomography (CT) or magnetic resonance imaging during or after the most recent therapy per RECIST v1.1 criteria., Candidate for the first chemotherapy in the locally advanced or metastatic setting a)Patients may have received prior anthracycline in the (neo)adjuvant setting or were considered not eligible or not a candidate for anthracyclines as assessed by the treating physician., Eligible for capecitabine, nab-paclitaxel, or paclitaxel. a) Patients who received taxane in the (neo)adjuvant setting can be treated with the same class of chemotherapy (taxane) if at least 12 months have elapsed between the completion of treatment with curative intent (eg, date of primary breast tumor surgery or date of last [neo]adjuvant chemotherapy administration, whichever occurred last) and the first docume
Progressive disease within 6 months of completing (neo)adjuvant chemotherapy., Have not recovered (ie, = Grade 2) from AEs due to a previously administered agent, with the exception of any grade alopecia or Grade 1 neuropathy. Note: If patients received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. Patients who underwent major surgery within 3 weeks of enrollment are not eligible., Have known active, symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis that requires treatment. Patients with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to enrollment and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases, and are taking no more than 10 mg/day of prednisone or its equivalent. All patients with carcinomatous meningitis are excluded regardless of clinical stability., Have an active second malignancy. Note: Patients with a history of malignancy that has been completely treated, with no evidence of active cancer for 3 years prior to enrollment, or patients with surgically cured tumors with low risk of recurrence (eg, nonmelanoma skin cancer, histologically confirmed complete excision carcinoma in situ, or similar) are eligible, Have a history of significant cardiovascular disease, defined as: a) Myocardial infarction or unstable angina pectoris within 6 months of enrollment. b) History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation. c) New York Heart Association Class III or greater congestive heart failure or known left ventricular ejection fraction of < 40%., Clinically significant ECG abnormality, including any of the following: a) Marked baseline prolonged QT/QT corrected (QTc) interval (ie, a repeated demonstration of a QTc interval > 500 ms) demonstrated on ECG at screening. b) History of risk factors for torsade de pointes (eg, heart failure, hypokalemia, family history of long QT Syndrome) or a history of torsade de pointes, Have an active serious bacterial, fungal, or viral infection requiring antibiotics., Have active hepatitis B virus (HBV) (defined as having a positive hepatitis B surface antigen test) or hepatitis C virus (HCV). In patients with a history of HBV or HCV, patients with detectable viral loads will be excluded. a) Patients who test positive for hepatitis B surface antigen will be excluded. b) Patients who test positive for hepatitis B core antibody will require HBV DNA by quantitative polymerase chain reaction (PCR) for confirmation of active disease. Patients with positive hepatitis B core antibody but negative viral load by PCR may be eligible if they are being monitored for potential viral reactivation or are willing to start or maintain antiviral treatment during study conduction (as dictated by their local and institutional standard practice or guidelines). A patient with a history of HBV infection and presence of hepatitis B surface antibody may participate in the study. In this last scenario, viral load (HBV DNA) is not mandated. c) Patients who test positive for HCV antibody will require HCV RNA by
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the effect of SG relative to the TPC on PFS;Secondary Objective: To compare the effect of SG relative to TPC on the following: - OS - ORR - Change from baseline in physical functioning domain and time to definitive deterioration (TTDD TTD) in Global Health Status/quality of life (QoL) as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30);Primary end point(s): PFS is the time from the date of randomization until the date of first objective progressive disease (PD) as assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), or death from any cause, whichever comes first
- Secondary Outcome Measures
Name Time Method Secondary end point(s):OS is the time from randomization until the date of death from any cause - ORR is defined as the percentage of patients who have achieved a CR or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response as assessed by BICR per RECIST v1.1 - Change from baseline in the physical functioning domain at Week 16;Secondary end point(s):TTD of Global Health Status/QoL domain of the EORTC QLQ C30 is defined as the time between the date of randomization and the date of assessment at which a patient experiences a deterioration (ie, =10 points worsening from baseline in the Global Health Status/QoL domain) or death