← Back to Search

Monoclonal Antibodies

Sacituzumab Govitecan +/- Pembrolizumab for Breast Cancer

Phase 2

Waitlist Available

Led By Sara C Tolaney, MD, MPH

Research Sponsored by Ana C Garrido-Castro

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have histologically or cytologically confirmed invasive breast cancer with unresectable locally advanced or metastatic disease

The participant must be capable of understanding and complying with the protocol and willing to sign a written informed consent document

Must not have

Participant has a medical condition that requires chronic systemic steroid therapy or any other form of immunosuppressive medication

History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying two different interventions to see how well they work in treating patients with HR+/HER2- breast cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include allergic reactions to medication components, fatigue, nausea, lowered blood cell counts increasing infection risk, potential lung issues like pneumonitis, and other immune-related adverse effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

I understand the study requirements and agree to participate.

Select...

My organs and bone marrow are functioning normally.

Select...

I agree to use birth control during and for 3 months after my treatment.

Select...

My breast cancer is HR-positive and HER2-negative.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I have had lung inflammation that needed steroids or have it now.

Select...

I have brain metastases that are either untreated, causing symptoms, or need treatment for symptom control.

Select...

I have not had major surgery in the last 2 weeks.

Select...

I am currently on steroids or immunosuppressants for an autoimmune disease.

Select...

I have previously been treated with specific immunotherapy drugs.

Select...

I do not have any severe illnesses that are not under control.

Select...

I have a specific genetic condition related to the UGT1A1*28 allele.

Select...

I have a history of HIV, Hepatitis B, or active Hepatitis C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression Free Survival

Secondary study objectives

Clinical Benefit Rate

Duration of Response

Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0"

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3130

Sacituzumab Govitecan

2019

Completed Early Phase 1

~30