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
The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to currently available standard treatments, such as paclitaxel, nab-paclitaxel or capecitabine. The primary objective is to compare the effect of SG relative to the treatment of physician's choice (TPC) on progression-free survival (PFS).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria:
* Able to understand and give written informed consent.
* Must have adequate tumor tissue sample preferably from locally recurrent or metastatic site.
* Documented evidence of HR+ metastatic breast cancer (mBC) confirmed with the most recently available tumor biopsy preferably 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 at least 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 (if ineligible or if unable to access a 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 PARP inhibitors (for those with germline BRCA1 or BRCA2 mutations), 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 and use of any investigational device or drug (drugs not marketed for any indication) either within 5 half-lives or 28 days prior to randomization, whichever is longer.
* Use of investigational drugs in the category of Selective Estrogen Receptor Degraders are acceptable if last dose was longer than 14 days prior to randomization.
* 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.
Primary outcome measure(s)
Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) — Up to approximately 29 months PFS is defined as time from date of randomization until the date of first objective progressive disease (PD) or death from any cause, whichever comes first.
Trial sites (288)
Facility
City
Region
Status
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Chandler
Arizona
Los Angeles Hematology Oncology Medical Group
Los Angeles
California
Stanford Cancer Institute
Palo Alto
California
University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
San Francisco
California
Rocky Mountain Cancer Centers, LLP
Littleton
Colorado
Yale-New Haven Hospital-Yale Cancer Center
New Haven
Connecticut
Investigational Drug Services, AdventHealth Orlando
Altamonte Springs
Florida
Florida Cancer Specialists
Brooksville
Florida
Florida Cancer Specialist
Leesburg
Florida
Florida Cancer Specialist
St. Petersburg
Florida
Piedmont Cancer Institute
Atlanta
Georgia
Georgia Cancer Specialist - Annex
Atlanta
Georgia
Northwest Georgia Oncology Centers
Marietta
Georgia
The University of Kansas Hospital
Kansas City
Kansas
Hematology Oncology Clinic
Baton Rouge
Louisiana
Saint Luke's Cancer Institute
Kansas City
Missouri
David C. Pratt Cancer Center
St Louis
Missouri
Astera Cancer Care
East Brunswick
New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick
New Jersey
Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
New York
New York
Cleveland Clinic
Cleveland
Ohio
Stefanie Spielman Comprehensive Breast Center
Columbus
Ohio
Penn State Cancer Institute
Hershey
Pennsylvania
Magee-Womens of UPMC
Pittsburgh
Pennsylvania
Prisma Health - Upstate
Greenville
South Carolina
Tennessee Oncology, PLLC
Nashville
Tennessee
Vanderbilt University Medical Center - Vanderbilt-Ingram Cancer Center
Nashville
Tennessee
US Oncology Investigational Products Center (IPC)
Fairfax
Virginia
US Oncology Investigational Products Center (IPC)
Norfolk
Virginia
MultiCare Regional Cancer Center - Auburn
Auburn
Washington
Hospital Britanico de Buenos Aires
Buenos Aires
Argentina
Instituto de Investigaciones Clinicas de Mar del Plata
Buenos Aires
Argentina
Instituto Alexander Fleming
C.a.b.a.
Argentina
Hospital Alemán
CABA
Argentina
Centro Privado de RMI Rio Cuarto S.A.
Córdoba
Argentina
Instituto de Oncología de Rosario
Rosario
Argentina
CER San Juan Centro Polivalente de Asistencia e Investigación Clínica
San Juan
Argentina
Royal Brisbane and Women's Hospital
Queensland
ME
St Vincent's Hospital Sydney
Darlinghurst
New South Wales
Liverpool Hospital
Liverpool
New South Wales
+ 248 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.