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Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer

Status
Active
Cancer Type
Breast Cancer
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT05382286
Protocol IDs
GS-US-592-6173 (primary)
NCI-2022-05480
2021-005742-14
jRCT2041220123
KEYNOTE-D19
Study Sponsor
Gilead

Summary

The primary objective of this study is to compare the progression-free survival (PFS) between
sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice
(TPC) and pembrolizumab in participants with previously untreated, locally advanced
inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell
death ligand 1 (PD-L1).

Eligibility

  1. 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.
  2. 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.
  3. Individuals presenting with de novo metastatic TNBC are eligible for this study.
  4. TNBC status and tumor PD-L1 combined positive score (CPS) will be confirmed centrally on a recent or archival tumor specimen.
  5. 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.
  6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  7. Demonstrates adequate organ function
  8. Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
  9. Individuals with HIV must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.