Pembrolizumab + Radiation for Breast Cancer

Recruiting in Palo Alto (17 mi)

Stephen L. Shiao, MD, PhD | Cedars-Sinai

Overseen byStephen Shiao, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Stephen Shiao

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This study is being done to assess the feasibility of pembrolizumab (study drug) combined with standard radiation to the tumor (tumor boost) before patients undergo standard treatment that can consist of one or more of the following: breast-conserving surgery, radiation to the entire breast/chest wall after surgery, and chemotherapy. Study participants will receive two doses of the study drug intravenously (through the vein) before their planned breast surgery or chemotherapy. The study drug will be administered three weeks apart. At the time of the second dose, radiation to the tumor in the affected breast will be given. This type of radiation treatment is called a "tumor boost", which is a standard part of radiation therapy for breast cancer that may occur either before or after planned breast-conserving surgery. Patients will receive breast surgery or begin chemotherapy approximately six weeks after your first dose of the study drug.

Eligibility Criteria

This trial is for adults with invasive breast cancer, specifically high-risk ER-positive/HER2-negative or triple-negative types without distant metastases. Participants must have a tumor ≥2 cm, be willing to undergo biopsies and adhere to the study schedule. It excludes those with certain cosmetic breast augmentations, other active cancers within 3 years, inflammatory breast cancer, contraindications to radiation therapy or breast-conserving therapy, known HIV/Hepatitis B/C infections, uncontrolled medical disorders or active autoimmune diseases.

Inclusion Criteria

My cancer has been tested for ER, PR, and HER2.

My cancer may or may not have spread to the lymph nodes.

I am fully active or can carry out light work.

+14 more

Exclusion Criteria

My breast cancer is HER2-positive based on specific test results.

I have an immune system disorder or am on long-term steroids.

I have another cancer that is getting worse or was treated in the last 3 years.

+11 more

Participant Groups

The trial tests pembrolizumab (an immunotherapy drug) combined with a 'tumor boost' of radiation before standard treatments like surgery or chemotherapy. Patients will receive two doses of pembrolizumab three weeks apart; during the second dose they'll also get radiation. Surgery or chemotherapy starts about six weeks after the first dose.

1Treatment groups

Experimental Treatment

Group I: Pembrolizumab with RT BoostExperimental Treatment2 Interventions

Study drug plus "tumor boost" before standard of care treatment