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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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 27 months

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

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Pneumothorax

Malnutrition, Hypercalcemia and Weakness

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

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

~2010

Vorinostat

2014

Completed Phase 3

~1600

Tamoxifen

2005

Completed Phase 4

~30070

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,514 Previous Clinical Trials

15,244,418 Total Patients Enrolled

46 Trials studying Breast Cancer

3,828,435 Patients Enrolled for Breast Cancer

Merck Sharp & Dohme LLCIndustry Sponsor

3,898 Previous Clinical Trials

5,062,617 Total Patients Enrolled

59 Trials studying Breast Cancer

7,406 Patients Enrolled for Breast Cancer

Pamela Munster, MDPrincipal InvestigatorUniversity of California, San Francisco

12 Previous Clinical Trials

486 Total Patients Enrolled

1 Trials studying Breast Cancer

122 Patients Enrolled for Breast Cancer

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

Recent research and studies

clinicaltrials.govStudy

Pembrolizumab and Tamoxifen With or Without Vorinostat for the Treatment of Estrogen Receptor Positive Breast Cancer

2021. "Pembrolizumab and Tamoxifen With or Without Vorinostat for the Treatment of Estrogen Receptor Positive Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04190056.