Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy (ASCENT-07)
Locally Advanced or Unresectable Metastatic Breast Cancer, Stage IV Breast Cancer
About this trial
This is an interventional treatment trial for Locally Advanced or Unresectable Metastatic Breast Cancer
Eligibility Criteria
Key Inclusion Criteria: Able to understand and give written informed consent. Must have adequate tumor tissue sample from locally recurrent or metastatic site. Documented evidence of HR+ metastatic breast cancer (mBC) confirmed with the most recently available tumor biopsy from a locally recurrent or metastatic site. Documented evidence of HER2- status. 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. Eligible for capecitabine, nab-paclitaxel, or paclitaxel. Individuals must have one of the following: Disease progression on at least 2 or more previous lines of endocrine therapy (ET) with or without a targeted therapy in the metastatic setting. Disease recurrence while on the first 24 months of starting adjuvant ET will be considered a line of therapy; these individuals will only require 1 line of ET in the metastatic setting. Disease progression within 6 months of starting first-line ET with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor in the metastatic setting. Disease recurrence while on the first 24 months of starting adjuvant ET with CDK 4/6 inhibitor and if the individual is no longer a candidate for additional ET in the metastatic setting. Individuals may have received prior targeted therapies, including but not limited to phosphatidylinositol 3-kinase (PI3K) inhibitors (for those with PIK3CA mutations) or mammalian target of rapamycin (mTOR) inhibitors. However, individuals can no longer be candidates for additional endocrine treatment with or without targeted therapies. Individuals with HIV must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease. Demonstrates adequate organ function. Male individuals and female individuals 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. Key Exclusion Criteria: Progressive disease within 6 months of completing (neo)adjuvant chemotherapy. Locally advanced metastatic breast cancer (mBC) (Stage IIIc) in individuals who are candidates for curative intent therapy at the time of study enrollment. Current enrollment in another clinical study or use of any investigational device or drug either within 5 half-lives or 28 days prior to randomization, whichever is longer. Received any prior treatment (including antibody-drug conjugate (ADC)) containing a chemotherapeutic agent targeting topoisomerase I. Received any prior treatment with a trophoblast cell-surface antigen 2 (Trop-2)-directed ADC. Have an active second malignancy. Have an active serious infection requiring antibiotics. Have active hepatitis B virus (HBV) or hepatitis C virus (HCV). Individuals positive for human immunodeficiency virus type 1/2 (HIV-1 or -2) with a history of Kaposi sarcoma and/or Multicentric Castleman Disease. Have a positive serum pregnancy test or are breastfeeding for individuals who are assigned female at birth. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- Ironwood Physicians P.C. dba Ironwood Cancer and Research CentersRecruiting
- Los Angeles Hematology Oncology Medical GroupRecruiting
- University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer CenterRecruiting
- Investigational Drug Services, AdventHealth OrlandoRecruiting
- Florida Cancer SpecialistsRecruiting
- Florida Cancer SpecialistRecruiting
- Florida Cancer SpecialistRecruiting
- Piedmont Cancer InstituteRecruiting
- Georgia Cancer Specialist - AnnexRecruiting
- Northwest Georgia Oncology CentersRecruiting
- The University of Kansas HospitalRecruiting
- Hematology Oncology ClinicRecruiting
- David C. Pratt Cancer CenterRecruiting
- Astera Cancer CareRecruiting
- Rutgers Cancer Institute of New JerseyRecruiting
- Cleveland ClinicRecruiting
- Magee-Womens of UPMCRecruiting
- MultiCare Regional Cancer Center - AuburnRecruiting
- Sunshine Hospital (Western Health)Recruiting
- Medizinische Universitat Wien, Univ. Klinik fur Innere Medizin I Klinische Abteilung fur OnkologieRecruiting
- AZ KlinaRecruiting
- CHU UCL Namur-Site STE. ElisabethRecruiting
- CHU de Québec-Université Laval, Hôpital du Saint-SacrementRecruiting
- Hong Kong Integrated Oncology CentreRecruiting
- Aichi Cancer Center HospitalRecruiting
- Chiba Cancer CenterRecruiting
- Osaka Prefectural Hospital Organization Osaka International Cancer InstituteRecruiting
- Saitama Cancer CenterRecruiting
- Cancer Institute Hospital of JFCRRecruiting
- Okayama University HospitalRecruiting
- Gunma Prefectural Cancer CenterRecruiting
- National Hospital Organization Hokkaido Cancer CenterRecruiting
- Center Hospital of the National Center for Global Health and MedicineRecruiting
- Kanagawa Cancer CenterRecruiting
- Gachon University Gil Medical CenterRecruiting
- Seoul National University Bundang HospitalRecruiting
- Seoul National University HospitalRecruiting
- Severance Hospital, Yonsei University Health SystemRecruiting
- Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z.o.oRecruiting
- Instytut MSF Sp. z o.o.Recruiting
- Tan Tock Seng HospitalRecruiting
- Hospital Clinic de BarcelonaRecruiting
- Hospital Universitario Reina SofiaRecruiting
- Hospital Universitario Ramón y CajalRecruiting
- Hospital Universitario 12 de OctubreRecruiting
- Hospital Universitario Virgen del RocioRecruiting
- Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
- National Taiwan University HospitalRecruiting
- Tri-Service General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Sacituzumab Govitecan-hziy (SG)
Treatment of Physician's Choice (TPC)
Participants will receive SG at a dose of 10 mg/kg infusion on Days 1 and 8 of a 21-day cycle.
Participants will receive TPC determined prior to randomization to 1 of the 3 allowed regimens: paclitaxel 80 mg/m^2 over 1 hour (± 10 minutes) on Days 1, 8, and 15 of a 28-day cycle. nab-Paclitaxel 100 mg/m^2 over 30 minutes (± 10 minutes) on Days 1, 8, and 15 of a 28-day cycle. capecitabine at 1000-1250 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period of a 21-day cycle.