Sacituzumab Govitecan for Breast Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Gilead Sciences

Must not be taking: Topoisomerase inhibitors, Trop-2 ADCs

Disqualifiers: Prior topoisomerase inhibitors, Trop-2 ADCs

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical study is to learn more about the study drug sacituzumab govitecan-hziy (SG) given at an alternative dose and schedule, in participants with triple-negative breast cancer (TNBC). The primary objectives of this study are to assess the safety and tolerability of SG given at alternate dose and schedule, to assess the effect on objective response rate (ORR) and progression-free survival (PFS).

Research Team

Gilead Study Director

Principal Investigator

Gilead Sciences

Eligibility Criteria

This trial is for adults with advanced triple-negative breast cancer (TNBC) who have tried at least one chemotherapy or systemic therapy. For phase 2, tumors must be PD-L1 negative or ineligible for anti-PD-(L)1 treatment due to other health issues. Participants need measurable disease and a good performance status score.

Inclusion Criteria

I have advanced TNBC and haven't had systemic therapy for it.

My breast cancer is triple-negative, confirmed by lab tests.

My UGT1A1 gene is normal.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Treatment

Participants receive sacituzumab govitecan until progressive disease, death, or unacceptable toxicity

Up to 9 months

Phase 2 Treatment

Further evaluation of safety, efficacy, and pharmacokinetics of sacituzumab govitecan

Up to 9 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years

Treatment Details

Interventions

• Sacituzumab Govitecan-hziy

Trial Overview The study tests an alternative dose and schedule of Sacituzumab Govitecan-hziy (SG), focusing on its safety, tolerability, how it affects the rate of tumor response, and time before the disease worsens in patients with TNBC.

Participant Groups

Group I: Phase 2: Expansion Experimental Treatment 1 Intervention

Participants will receive SG until PD, death, unacceptable toxicity, or another treatment discontinuation criterion is met.

Group II: Phase 1 Experimental Treatment 1 Intervention

Participants will receive SG until progressive disease (PD), death, unacceptable toxicity, or another treatment discontinuation criterion is met.

Who Is Running the Clinical Trial?

Gilead Sciences

Lead Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine