問卷
Log In
繁中 EN
TPIDB
TPIDB Outstanding PI
TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol NumberGS-US-592-6173
NCT Number(ClinicalTrials.gov Identfier)NCT05382286
Active

2022-10-01 - 2026-12-31

Phase III

Not yet recruiting3

Recruiting5

ICD-10C79.81

Secondary malignant neoplasm of breast

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9198.81

Secondary malignant neoplasm of breast

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1

  • Trial Applicant

    GILEAD SCIENCES HONG KONG LIMITED

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Chiun-Sheng Huang Division of General Surgery
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSU-YI CHAO Division of Hematology & Oncology
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Wen-Ling Kuo Division of General Surgery
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 陳守棟 Division of General Surgery
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Fang-Ming Chen Division of General Surgery
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

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 Not yet recruiting

Principal Investigator Shang-Wen Chen Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wei-Pang Chung Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Triple Negative Breast Cancer、PD-L1 Positive

Objectives

Main purpose: ‧ Comparison of progression-free survival (PFS) assessed by blinded independent central review (BICR) between sacituzumab govitecan (SG) and pembrolizumab, compared with treatment of physician's choice (TPC) and pembrolizumab Secondary Purpose: ‧ Comparison of overall survival (OS) between the two groups ‧ Comparison of objective response rate (ORR) assessed by BICR between the two groups ‧ Comparison of duration of response (DOR) assessed by BICR between the two groups ‧ Comparison of time to response (TTR) assessed by BICR between the two groups ‧ Compare the safety and tolerability between the two groups ‧ To compare the time to deterioration of overall health status/quality of life (QOL), pain, and fatigue as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30 [version 3.0]) between the 2 groups Exploratory purpose: ‧ To evaluate tumor expression of trophoblast cell surface antigen-2 (Trop-2) as a potential biomarker of response to SG plus pembrolizumab ‧ Explore blood and tumor biomarkers that may be associated with response to SG plus pembrolizumab ‧ To explore the relationship between adverse events (AEs) and urinary glycosylation glucuronidase 1A1 (UGT1A1) status ‧ Characterize the pharmacokinetic (PK) and immunogenicity properties of SG Additional QOL outcomes measured by the 5-level EuroQoL (EQ-5D-5L), European Organisation for Research and Treatment of Cancer Breast Cancer Component (EORTC QLQ-BR23), EORTC QLQ-C30, and FACT-GP5 were compared between the 2 groups.

Test Drug

Sacituzumab Govitecan

Active Ingredient

Sacituzumab Govitecan

Dosage Form

Lyophilizate for Solution for Infusion

Dosage

10 mg/kg

Endpoints

Main evaluation indicators:
PFS was defined as the time from the date of randomization to the date of objective disease progression (PD) as assessed by BICR according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death, whichever occurred first.

Inclution Criteria

Key Inclusion Criteria:

Individuals with locally advanced, inoperable, or metastatic triple-negative breast cancer (TNBC) who have not received previous systemic therapy for advanced disease and whose tumors are programmed cell death ligand 1 (PD-L1) positive at screening.

Individuals must have completed treatment for Stage I to III breast cancer, if indicated, and ≥ 6 months must have elapsed between completion of treatment with curative intent and first documented local or distant disease recurrence.
Individuals presenting with de novo metastatic TNBC are eligible for this study.
TNBC status and tumor PD-L1 combined positive score (CPS) will be confirmed centrally on a recent or archival tumor specimen.
Individuals must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria as evaluated locally.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Demonstrates adequate organ function
Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
Individuals with HIV must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease.

Exclusion Criteria

Key Exclusion Criteria:

Positive serum pregnancy test or women who are lactating.
Received prior therapy with an agent directed to another stimulatory or coinhibitory T-cell receptor.
Individuals may not have received systemic anticancer treatment (with the exception of endocrine therapy) within the previous 6 months or radiation therapy within 2 weeks prior to enrollment.
Individuals may not be participating in a study with an investigational agent or investigational device within 4 weeks prior to randomization. Individuals participating in observational studies are eligible.
Have previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor.
Have an active second malignancy.
Have active serious infection requiring antibiotics.
Individuals positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
Have active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
Has an active autoimmune disease that has required systemic treatment in the past 2 years.

The Estimated Number of Participants

  • Taiwan

    24 participants

  • Global

    440 participants

聯絡我們

台灣臨床試驗主持人資料庫 TPIDB

All Contents Copyright 2020 台灣臨床試驗主持人資料庫TPIDB