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Comparing sacituzumab govitecan-hziy to physician's choice treatment for advanced triple-negative breast cancer

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1

Phase 3 Interventional Gilead Sciences · NCT05382299

This study is testing if a new treatment called sacituzumab govitecan-hziy can help people with advanced triple-negative breast cancer live longer without their cancer getting worse compared to standard treatment options chosen by their doctors.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment540 (estimated)
Ages18 Years and up
SexAll
SponsorGilead Sciences Industry-sponsored
Drugs / interventionsradiation, sacituzumab
Locations516 sites (Anchorage, Alaska and 515 other locations)
Trial IDNCT05382299 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of sacituzumab govitecan-hziy (SG) compared to treatment of physician's choice (TPC) in patients with previously untreated, locally advanced, inoperable, or metastatic triple-negative breast cancer (TNBC). The primary focus is on measuring progression-free survival (PFS) in participants whose tumors do not express PD-L1. Eligible patients include those with confirmed TNBC and specific PD-L1 status, ensuring a targeted approach to treatment. The study will involve various treatment options, including SG and standard chemotherapies.

Who should consider this trial

Good fit: Ideal candidates are individuals with previously untreated locally advanced or metastatic triple-negative breast cancer, particularly those with PD-L1 negative tumors.

Not a fit: Patients with early-stage breast cancer or those whose tumors express PD-L1 without prior anti-PD-(L)1 treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with advanced triple-negative breast cancer.

How similar studies have performed: Other studies have shown promising results with similar treatment approaches in triple-negative breast cancer, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* Individuals, regardless of race and ethnic group, with previously untreated locally advanced, inoperable or metastatic triple-negative breast cancer (TNBC)

  * Individuals whose tumors are programmed cell death ligand 1 (PD-L1) negative at screening or individuals whose tumors are PD-L1 positive at screening if they have received an anti-PD-(L)1 inhibitor in the (neo) adjuvant setting or if they cannot be treated with a checkpoint inhibitor due to a comorbidity
  * Centrally confirmed TNBC and PD-L1 status on fresh or archival tissue
  * Individuals must have completed treatment for Stage I-III breast cancer, if indicated, and ≥ 6 months must have elapsed (with the exception of endocrine therapy) between completion of treatment with curative intent and first documented local or distant disease recurrence
  * Individuals presenting with de novo metastatic TNBC are eligible
* Measurable disease based on computed tomography (CT) or magnetic resonance imaging (MRI) in accordance with per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. as evaluated locally
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* 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
* Individuals with human immunodeficiency virus (HIV) must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease

Key Exclusion Criteria:

* Positive serum pregnancy test or women who are lactating
* Received systemic anticancer treatment within the previous 6 months or radiation therapy within 2 weeks prior to enrollment
* Have not recovered from adverse events (AEs) due to a previously administered agent at the time study entry
* 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
* Previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor
* Active second malignancy
* Active serious infection requiring antibiotics
* Positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease
* Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where this trial is running

Anchorage, Alaska and 515 other locations

+466 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Triple Negative Breast CancerPD-L1 Negative
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.