Sacituzumab Govitecan +/- Pembrolizumab for Breast Cancer

Recruiting in Palo Alto (17 mi)

+8 other locations

Sara M. Tolaney, MD, MPH - Dana-Farber ...

Overseen byAna C. Garrido-Castro

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Ana C Garrido-Castro

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This research study is evaluating the safety and effectiveness of Sacituzumab Govitecan with or without Pembrolizumab in metastatic HR+/HER2- breast cancer. The names of the study interventions involved in this study are: * Sacituzumab govitecan (IMMU-132) * Pembrolizumab (Keytruda®; MK-3475)

Eligibility Criteria

This trial is for adults with advanced or metastatic HR+/HER2- breast cancer who have seen their disease progress after hormone therapy. They should have measurable disease, be able to undergo biopsies, and not exceed one prior chemo treatment for metastasis. Participants need normal organ function and must agree to contraception if applicable.

Inclusion Criteria

My cancer worsened during or after hormone therapy, and I am now considered suitable for chemotherapy.

My breast cancer is advanced and cannot be removed by surgery.

I agree to have two biopsies: one now and another 3-6 weeks after starting treatment.

+7 more

Exclusion Criteria

I am on long-term steroids or other drugs that weaken my immune system.

You had an allergic reaction to the ingredients in pembrolizumab or sacituzumab govitecan therapy before.

Participants who are breast-feeding are not eligible for enrollment

+11 more

Participant Groups

The study tests the effectiveness of Sacituzumab Govitecan alone or combined with Pembrolizumab in treating certain breast cancers. It assesses safety, how well tumors respond, and compares outcomes between the two approaches.

3Treatment groups

Experimental Treatment

Group I: Sacituzumab Govitecan + PembrolizumabExperimental Treatment2 Interventions

The research study procedures include: screening for eligibility, research blood collections, at least two research biopsies, paired research stool collections, and study treatment including evaluations and follow up visits. Each Cycle =21 Days * Sacituzumab Govitecan (iv) fixed dose, administered twice per cycle * Pembrolizumab (iv) fixed dose administered once per cycle

Group II: Sacituzumab GovitecanExperimental Treatment1 Intervention

The research study procedures include: screening for eligibility, research blood collections, at least two research biopsies, paired research stool collections, and study treatment including evaluations and follow up visits. - Sacituzumab Govitecan (iv) fixed dose, administered twice per cycle

Group III: RetreatmentExperimental Treatment2 Interventions

Participants who have attained a confirmed complete response (CR) who have been treated for at least 24 weeks on protocol therapy and had at least three cycles (with pembrolizumab and sacituzumab govitecan (Arm A) or sacituzumab govitecan alone (Arm B)) beyond the date when the initial CR was declared may be eligible for additional sacituzumab govitecan and/or pembrolizumab therapy if they progress after stopping study treatment. This retreatment is termed the Second Course Phase of this study and is only available if the study remains open and the subject meets protocol-specified conditions.

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸 Approved in United States as KEYTRUDA for: