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Active (not recruiting) Phase 3 NCT05840211

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

Phase 3 – large-scale trial before approval
Conditions: Locally Advanced or Unresectable Metastatic Breast Cancer Stage IV Breast Cancer

Sponsor: Gilead Sciences

trial.available_in: БГ
Overview
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).
Who can participate
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.
Locations 26
Argentina (1)
Hospital Britanico de Buenos Aires
Buenos Aires
Australia (1)
Royal Brisbane and Women's Hospital
Queensland , ME
Belgium (1)
GZA Ziekenhuizen - Campus Sint-Augustinus
Antwerp
Brazil (1)
Hospital Haroldo Juaçaba - Instituto do Câncer do Ceará
Fortaleza
Canada (1)
BC Cancer - Kelowna
Kelowna
Chile (1)
Centro de Investigacion Clinica Bradford Hill
Recoleta
China (1)
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Anhui
Czech Republic (1)
Fakultni Nemocnice Brno
Brno
France (1)
CHU Jean Minjoz
Besançon
Germany (1)
Universitaetsklinikum Freiburg, Klinik fuer Frauenheilkunde
Baden-Württemberg
Greece (1)
Alexandra General Hospital
Athens
Hong Kong (1)
Hong Kong Integrated Oncology Centre
Hong Kong
Hungary (1)
Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika
Budapest
Israel (1)
Oncology Institute Rambam Health Care Campus
Haifa
Italy (1)
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
Ancona AN
Japan (1)
Aichi Cancer Center Hospital
Aichi
Malaysia (1)
Hospital Kuala Lumpur
Kuala Lumpur
Mexico (1)
Centro de Investigacion y Avances Medicos Especializados
Cancún
Poland (1)
Copemicus Podmiot Leczniczy Wojewodzkie Centrum Okologii w Gdansku
Gdansk
Singapore (1)
National University Hospital
Singapore
South Africa (1)
Wilgers Oncology Centre
Gauteng
South Korea (1)
Samsung Medical Center
Gangnam-Gu
Spain (1)
Hospital Universitari Dexeus
Barcelona
Taiwan (1)
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
United Kingdom (1)
Barts Cancer Institute
London
United States (1)
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Chandler , Arizona
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
08.05.2023
Completion date
01.04.2028
Registry ID
NCT05840211
Source
anzctr
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