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Monoclonal Antibodies

Pembrolizumab for Breast Cancer

Phase 2
Waitlist Available
Led By Pamela Munster, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Toxicity related to prior therapies that, in the opinion of the investigator, would potentially be worsened with anti-PD1 therapy should be resolved to less than grade 1
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 27 months
Awards & highlights

Study Summary

This trial is studying a combination of immunotherapy and hormone therapy to better control estrogen receptor positive breast cancer.

Eligible Conditions
  • Breast Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Any negative effects from previous treatments that could get worse with this new treatment need to be resolved or improved to a mild level.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 27 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 27 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate (ORR)
Secondary outcome measures
Duration of Response (DOR)
Median Overall Survival (OS)
Median Progression Free Survival (PFS)
+1 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B (pembrolizumab, tamoxifen)Experimental Treatment2 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1 and tamoxifen PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression of unacceptable toxicity.
Group II: Arm A (pembrolizumab, vorinostat, tamoxifen)Experimental Treatment3 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1, vorinostat PO QD for 4 days weekly, and tamoxifen PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression of unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~1950
Vorinostat
2014
Completed Phase 3
~1600
Tamoxifen
2005
Completed Phase 4
~29860

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,493 Previous Clinical Trials
11,931,797 Total Patients Enrolled
46 Trials studying Breast Cancer
3,828,435 Patients Enrolled for Breast Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,862 Previous Clinical Trials
5,049,699 Total Patients Enrolled
58 Trials studying Breast Cancer
7,456 Patients Enrolled for Breast Cancer
Pamela Munster, MDPrincipal InvestigatorUniversity of California, San Francisco
11 Previous Clinical Trials
364 Total Patients Enrolled

Frequently Asked Questions

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

Has the FDA sanctioned Pembrolizumab for medical use?

"Based on the available clinical data, our team at Power has assigned a score of 2 for pembrolizumab's safety rating. This is due to it being classified as a Phase 2 trial; hence there are results validating its safety but none supporting efficacy."

Answered by AI

What medical conditions has Pembrolizumab been demonstrated to aid in healing?

"Pembrolizumab is often prescribed as a cancer therapy, but it also has applications in treating unresectable melanoma, microsatellite instability high, and progressive cutaneous t-cell lymphoma."

Answered by AI

How many participants are being considered for inclusion into this medical trial?

"Affirmative. Clinicaltrials.gov demonstrates that this medical trial is currently recruiting patients as of January 29th 2022, a year after it was initially posted on March 11th 2021. The research requires 65 participants to be recruited from one centre."

Answered by AI

Has Pembrolizumab been tested in previous clinical trials?

"Presently, 1051 studies investigating pembrolizumab are underway. Of these investigations, 146 have reached the third phase of clinical trials. Though this drug is primarily tested in Scottsdale, Arizona, a staggering 43 790 unique locations are hosting Pembroilzumab research initiatives."

Answered by AI

Is the recruitment of participants ongoing for this research effort?

"Affirmative. According to clinicaltrials.gov, this medical investigation is actively seeking participants since its initial post date on March 11th 2021 and last edit on January 29th 2022. 65 patients need to be recruited from one site of the study."

Answered by AI
~0 spots leftby Mar 2025