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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 may have received 0-1 prior chemotherapeutic regimens for metastatic breast cancer and must have been off treatment with chemotherapy for at least 14 days prior to study treatment initiation
Participants must have either progressed on or within 12 months of adjuvant endocrine therapy or have progressed on at least one line of endocrine therapy for metastatic disease, and be considered appropriate candidates for chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
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I have had at most one chemotherapy for my metastatic breast cancer and have not been on chemotherapy for the last 14 days.
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My cancer worsened during or after hormone therapy, and I am now considered suitable for chemotherapy.
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My breast cancer is advanced and cannot be removed by surgery.
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I agree to have two biopsies: one now and another 3-6 weeks after starting treatment.
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I am a woman who can have children, tested negative for pregnancy, and agree to use birth control.
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I understand the study requirements and agree to participate.
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My organs and bone marrow are functioning normally.
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I agree to use birth control during and for 3 months after my treatment.
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My breast cancer is HR-positive and HER2-negative.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival
Secondary outcome measures
Clinical Benefit Rate
Duration of Response
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0"
+4 more

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 2
~1950

Find a Location

Who is running the clinical trial?

Ana C Garrido-CastroLead Sponsor
Ana C Garrido-Castro, MDLead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor
3,862 Previous Clinical Trials
5,049,590 Total Patients Enrolled
58 Trials studying Breast Cancer
7,456 Patients Enrolled for Breast Cancer

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04448886 — Phase 2
Breast Cancer Research Study Groups: Retreatment, Sacituzumab Govitecan + Pembrolizumab, Sacituzumab Govitecan
Breast Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT04448886 — Phase 2
Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04448886 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What indications has Sacituzumab Govitecan been approved to treat?

"Sacituzumab Govitecan is a common choice of treatment for malignant neoplasms as well as unresectable melanoma, microsatellite instability high and conditions that have progressed after chemotherapy."

Answered by AI

Could you elucidate the previous experiments involving Sacituzumab Govitecan?

"Sacituzumab Govitecan was first investigated at City of Hope a decade ago, and since then it has been subject to 253 clinical trials. This number is expected to rise with 990 active studies currently taking place around South Weymouth, Illinois."

Answered by AI

Are there opportunities for people to enroll in this experiment currently?

"Affirmative, data hosted on clinicaltrials.gov confirm that this medical study is actively seeking participants. The trial was initially posted on September 23rd 2020 and has been recently revised as of November 14th 2022. 110 individuals need to be recruited from 8 distinct clinics."

Answered by AI

How many facilities are currently conducting this trial?

"This clinical trial is being conducted across a network of medical centres including DF/BWCC in affiliation with South Shore Hospital located in South Weymouth, Illinois; Dana Farber Cancer Institute situated in Boston, Pennsylvania; and University of Chicago Medical Center based out of Chicago, Georgia. There are 8 other sites involved as well."

Answered by AI

Is there any potential for harm associated with taking Sacituzumab Govitecan?

"As this is a phase 2 clinical trial, our team assigned Sacituzumab Govitecan with an estimation of safety at a level 2 due to the limited data available on efficacy."

Answered by AI

Approximately how many individuals are engaged in this research?

"Affirmative. The clinical trial, initially posted on September 23rd 2020, is actively recruiting participants according to the information displayed on clinicaltrials.gov. A total of 110 patients are required across 8 different medical sites for this study."

Answered by AI
~24 spots leftby Mar 2025