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Clinical Trials List

Protocol NumberGS-US-598-6168
NCT Number(ClinicalTrials.gov Identfier)NCT05840211
Active

2023-06-30 - 2029-02-28

Phase III

Recruiting10

ICD-10C50.011

Malignant neoplasm of nipple and areola, right female breast

ICD-10C50.012

Malignant neoplasm of nipple and areola, left female breast

ICD-10C50.019

Malignant neoplasm of nipple and areola, unspecified female breast

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9174.0

Malignant neoplasm of female breast, nipple and areola

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH-]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy

  • Trial Applicant

    GILEAD SCIENCES HONG KONG LIMITED

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator TSU-YI CHAO 無
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shang-Wen Chen 無
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 鍾奇峰 無
Koo Foundation Sun Yat-Sen Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator YEN-SHEN LU 無
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 戴明燊 無
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 劉建廷 無
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ling-Ming Tseng Division of General Surgery
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Ling Kuo 無
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ming-Feng Hou 無
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wei-Pang Chung
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Locally Advanced or Unresectable Metastatic Breast Cancer、 Stage IV Breast Cancer

Objectives

Primary objective: To compare the effects of sacituzumab govitecan (SG) versus physician’s choice (TPC) on progression-free survival (PFS). Key secondary objectives: To compare the effects of SG versus TPC on: —Overall survival (OS) —Objective response rate (ORR) —Changes in overall health status/quality of life (QoL) in the physical functioning domain since baseline, as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire version 3.0 (EORTC QLQ-C30) and time to deterioration (TDD).

Test Drug

注射劑

Active Ingredient

sacituzumab govitecan

Dosage Form

270

Dosage

180 mg

Endpoints

PFS refers to the time from the date of randomization to the date of the first objective disease progression (PD) assessed by a blinded independent central review (BICR) according to the Responsive Criteria for Solid Tumor Response, version 1.1 (RECIST v1.1), or death from any cause (whichever comes first).

Inclution Criteria

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.

Exclusion Criteria

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.

The Estimated Number of Participants

  • Taiwan

    90 participants

  • Global

    654 participants

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