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Clinical Trials in the UK / NCT05840211
Active, not recruiting Phase 3

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

NCT05840211 · tracked via the Priya Life Science UK tracker
Sponsor
Gilead Sciences
Phase
Phase 3
Started
2023-05-08
Last updated
2025-10-03

Condition(s) studied

Locally Advanced or Unresectable Metastatic Breast CancerStage IV Breast Cancer

Investigational drug(s) / intervention(s)

Sacituzumab Govitecan-hziyPaclitaxelNab-paclitaxelCapecitabine

Sacituzumab Govitecan-hziy: Administered intravenously

Paclitaxel: Administered intravenously

Nab-paclitaxel: Administered intravenously

Capecitabine: Administered orally

Study summary

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)

Trial sites (288)

FacilityCityRegionStatus
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.

More Gilead Sciences trials in the UK

Official registry record

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.

View NCT05840211 on ClinicalTrials.gov ↗ ← All trials in the UK