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Sacituzumab Govitecan for Advanced Triple-Negative Breast Cancer

This study is looking at a different way to give sacituzumab govitecan-hziy (SG), a treatment for advanced triple-negative breast cancer (TNBC). Sacituzumab govitecan-hziy is an antibody-drug conjugate (ADC), which means it combines an antibody that targets cancer cells with a chemotherapy drug. The main goals are to see how safe and tolerable this new dose and schedule are, and how well it shrinks tumors (objective response rate) and keeps the cancer from growing (progression-free survival). You may be able to join if you are 18 or older, have TNBC that has come back or not responded to at least one previous chemotherapy, and are able to give informed consent. The study is currently unclear on its recruitment status.

Study design
This is an interventional study with a planned enrollment of 100 participants. It has both a Phase 1 to assess preliminary safety and a Phase 2 to further evaluate safety and effectiveness.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events and laboratory abnormalities for up to 30 days after their last dose, and potentially up to 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06926920

A Study of Sacituzumab Govitecan Given at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
Gilead Sciences
~100 participants
Updated 2026-01-30 on ClinicalTrials.gov
What's tested:Sacituzumab Govitecan-hziy (SG)

At a glance

Recruiting sites
15 of 16 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1: Percentage of Participants Experiencing Dose-Limiting Toxicities (DLTs)
Measured over First dose up to 28 days
+5 more outcomes measured

Conditions

Triple Negative Breast Cancer

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Triple-negative breast cancer

NCT06926920

Where you'd take part

This study runs at 16 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Asan Medical Center

    Seoul, South Koreano site contact published

    Recruiting

  • John Flynn Private Hospital

    Tugun, Queensland, Australiano site contact published

    Recruiting

  • Los Angeles Cancer Network (LACN) - Good Sam

    Los Angeles, Californiano site contact published

    Recruiting

  • Samsung Medical Center

    Seoul, South Koreano site contact published

    Recruiting

  • SCRI Oncology Partners

    Nashville, Tennesseeno site contact published

    Recruiting

  • Seoul National University Hospital

    Seoul, South Koreano site contact published

    Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, South Koreano site contact published

    Not yet recruiting

  • Siteman Cancer Center

    St Louis, Missourino site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Gilead Study Director · STUDY_DIRECTOR · Gilead Sciences

Who to contact

Gilead Clinical Study Information Center
[email protected]
1-833-445-3230 (GILEAD-0)
Email the study team

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Eligibility criteria

Inclusion

Individuals assigned male or female at birth, 18 years of age or older, able to understand and give written informed consent.
Histologically or cytologically locally confirmed TNBC.
Phase 1: Individuals with unresectable, locally advanced or metastatic TNBC who are refractory to or relapsed after at least one prior standard-of-care chemotherapy regimen or systemic therapy given for locally advanced or metastatic disease.
Phase 2: Individuals with unresectable, locally advanced or metastatic TNBC who have not received previous systemic therapy for advanced disease.
Phase 2: Tumors must be PD-L1 negative, defined as tumor PD-L1 combined positive score (CPS) \< 10 using the PD-L1 immunohistochemistry (IHC) 22C3 assay. Alternatively, individuals with tumor CPS ≥ 10 will be eligible if they received an anti-PD-(L)1 agent (ie, checkpoint inhibitor) in the adjuvant or neoadjuvant setting or if they cannot be treated with an anti-PD-(L)1 agent. due to a comorbidity.
Uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) genotype status.
Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) according to RECIST Version 1.1 criteria.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Adequate hematologic counts within 2 weeks prior to enrollment.
Adequate hepatic and renal function.

Exclusion

Prior treatment with a topoisomerase 1 inhibitor or antibody-drug conjugate (ADC) containing a topoisomerase inhibitor.
Prior treatment with a trophoblast cell-surface antigen 2 (Trop-2)-directed ADC.

What this trial measures

  • Phase 1: Percentage of Participants Experiencing Dose-Limiting Toxicities (DLTs)First dose up to 28 days
  • Phase 1 and 2: Percentages of Participants Experiencing Adverse Events (AEs)First dose up to 30 days post last dose (Up to 3 years)
  • Phases 1 and 2: Percentages of Participants Experiencing Laboratory AbnormalitiesFirst dose up to 30 days post last dose (Up to 3 years).
  • Phases 1 and 2: Percentages of Participants Experiencing AEs Leading to Dose Reductions, Dose Interruptions, and Treatment DiscontinuationsFirst dose up to 30 days post last dose (Up to 3 years).
  • Phases 1 and 2: Objective Response Rate (ORR)Up to 9 months

    ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.

  • Phase 2: Progression-Free Survival (PFS)Up to 9 months

    PFS is defined as the time from the date of the first SG dose until the date of progressive disease (PD) as assessed by the investigator according to RECIST Version 1.1, or death from any cause, whichever occurs first.