Sacituzumab Govitecan for Breast Cancer

Recruiting at 18 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a treatment called sacituzumab govitecan (an antibody-drug conjugate) to determine if adjusting its dose and schedule can benefit people with advanced or metastatic triple-negative breast cancer (TNBC). The main goals are to assess the safety and tolerability of this treatment and evaluate its effectiveness in halting cancer growth and improving progression-free survival. Suitable participants include those with TNBC who have either not responded to previous treatments or have not yet received treatment for advanced cancer. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to early-stage cancer research.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that sacituzumab govitecan-hziy is likely to be safe for humans?

Research shows that sacituzumab govitecan-hziy is generally well-tolerated by people with breast cancer. Common side effects include hair loss, low levels of red and white blood cells, and diarrhea. Studies have found that these side effects align with expectations from earlier research, with no new safety concerns. This indicates that the treatment's side effects are consistent with those observed in previous studies. Additionally, sacituzumab govitecan is already approved for treating metastatic triple-negative breast cancer, demonstrating that its safety in humans is well-established. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for breast cancer?

Sacituzumab govitecan-hziy is unique because it combines an antibody targeting Trop-2, a protein frequently overexpressed in breast cancer cells, with a powerful chemotherapy agent called SN-38. This targeted approach allows the treatment to deliver chemotherapy directly to the cancer cells, potentially increasing effectiveness while reducing damage to healthy cells. Researchers are excited about sacituzumab govitecan-hziy because it offers a novel mechanism of action compared to standard treatments like hormone therapy or traditional chemotherapy, which can affect both cancerous and healthy cells. This targeted delivery system could lead to fewer side effects and improved outcomes for patients with breast cancer.

What evidence suggests that sacituzumab govitecan-hziy might be an effective treatment for triple-negative breast cancer?

Studies have shown that sacituzumab govitecan-hziy (SG) can effectively treat triple-negative breast cancer (TNBC). In one study, patients using SG lived a median of 12.1 months, nearly double the 6.7 months for those not using it. Another report found that patients experienced a median of 4.8 months before their cancer worsened, indicating they lived longer without disease progression. These results suggest that SG can significantly improve outcomes for patients with TNBC. Participants in this trial will receive SG until they experience progressive disease, death, unacceptable toxicity, or meet another treatment discontinuation criterion. ^{2 3 4 6 7}

Who Is on the Research Team?

Gilead Study Director

Principal Investigator

Gilead Sciences

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/OP.24.00242

Real-World Clinical Outcomes With Sacituzumab ... Results · Survival Outcomes. The median PFS was 4.8 months (95% CI, 3.6 to 5.9; Fig 2). · Effectiveness of T-DXs After SG · AEs.

2. esmoopen.com esmoopen.com/article/S2059-7029(25)01177-9/fulltext

Effectiveness of sacituzumab govitecan and management ... We describe the real-world effectiveness of SG as 2L+ mTNBC treatment and the proportion of patients with neutropenia and its management.

3. gilead.com gilead.com/news/news-details/2025/gilead-provides-update-on-phase-3-ascent-07-study

Gilead Provides Update on Phase 3 ASCENT 07 Study The ASCENT-07 study is a global, open-label, randomized Phase 3 trial evaluating the efficacy and safety of Trodelvy (sacituzumab govitecan-hziy) ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40361516/

The Clinical Outcomes and Safety of Sacituzumab ... Conclusions: SG was associated with similar clinical outcomes and tolerability in both the mTNBC and mHRPBC subtypes. Although the real-world ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2028485

Sacituzumab Govitecan in Metastatic Triple-Negative ... The median overall survival was 12.1 months (95% CI, 10.7 to 14.0) with sacituzumab govitecan and 6.7 months (95% CI, 5.8 to 7.7) with ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S096097762400184X

Safety profile of sacituzumab govitecan in patients with ... The outcomes of interest were absolute risk (AR) of all-grade and grade ≥3 TRAEs: neutropenia; nausea; diarrhea; anemia; febrile neutropenia; alopecia; fatigue; ...

7. onclive.com onclive.com/view/sacituzumab-govitecan-upholds-efficacy-and-safety-in-real-world-mtnbc-population

Sacituzumab Govitecan Upholds Efficacy and Safety in ... Sacituzumab govitecan demonstrated consistent efficacy and safety in real-world mTNBC patients, with median OS of 11.3 months and PFS of 5.0 ...