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Monoclonal Antibodies

Sacituzumab Govitecan + Pembrolizumab for Breast Cancer

Phase 2
Recruiting
Led By Clinton Yam, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically confirmed breast cancer T1c N1-2 or T2-4 N0-2 early-stage disease
ER/PR negative (ER/PR <1%) or ER/PR low positive (1%≤ER/PR≤10%), and HER2 negative as per institutional and ASCO-CAP guidelines
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights

Study Summary

This trial studies if two drugs can help treat early-stage triple negative breast cancer that is not responding to other treatments.

Who is the study for?
This trial is for adults with early-stage triple-negative breast cancer that hasn't improved with initial treatment. Participants must have specific tumor characteristics, agree to biopsies, and use effective birth control if of childbearing potential. Exclusions include prior treatments for the current cancer, certain health conditions, pregnancy, or active infections.Check my eligibility
What is being tested?
The study tests whether sacituzumab govitecan and pembrolizumab given before surgery can manage early-stage triple-negative breast cancer resistant to initial therapy. It's a phase II trial focusing on patients who didn't respond well to first-line immunochemotherapy.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to medication components, immune-related issues affecting organs due to pembrolizumab, gastrointestinal problems from Sacituzumab Govitecan, fatigue, and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer is in the early stages and has been confirmed by a lab test.
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My cancer is either not responsive to hormones or barely responsive, and does not have too much HER2.
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I agree to have a biopsy after my initial cancer treatment.
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My tumor size hasn’t changed or has grown after starting the KN-522 treatment.
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My organ functions are within normal ranges according to recent tests.
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I started treatment with pembrolizumab and chemotherapy (paclitaxel + carboplatin).
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I am 18 years old or older.
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I am not pregnant or incapable of becoming pregnant.
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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Trial Design

1Treatment groups
Experimental Treatment
Group I: Sacituzumab Govitecan and PembrolizumabExperimental Treatment2 Interventions
Participants will receive drug on Days 1 and 8 of Cycles 1-4, Participants will receive sacituzumab govitecan by vein. Participants will receive drug on Days 1, 8, and 15 of each cycle, Participants will receive pembrolizumab by vein.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,339 Total Patients Enrolled
147 Trials studying Breast Cancer
63,261 Patients Enrolled for Breast Cancer
Gilead SciencesIndustry Sponsor
1,078 Previous Clinical Trials
836,488 Total Patients Enrolled
16 Trials studying Breast Cancer
6,429 Patients Enrolled for Breast Cancer
Clinton Yam, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05675579 — Phase 2
Breast Cancer Research Study Groups: Sacituzumab Govitecan and Pembrolizumab
Breast Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT05675579 — Phase 2
Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05675579 — Phase 2

Frequently Asked Questions

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

How hazardous are Sacituzumab Govitecan and Pembrolizumab to patients' health?

"Our assessment of the safety profiles for Sacituzumab Govitecan and Pembrolizumab, based on Phase 2 trial results, is a score of 2 since there are some data supporting its security but none that support its efficacy."

Answered by AI

Are there any vacancies currently available for this medical trial?

"Reports from clinicaltrials.gov state that this particular research is not currently enrolling any participants, despite its initial posting date of June 30th 2023 and last update on December 22nd 2022. Nevertheless, there are plenty of other medical studies actively seeking candidates at the moment; approximately 2564 in total."

Answered by AI
~14 spots leftby Mar 2025