Pre-op Pembro + Radiation Therapy for Breast Cancer

Recruiting in Palo Alto (17 mi)

+10 other locations

Overseen byLaura M Spring, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Laura M. Spring, MD

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This research trial is studying a combination of neoadjuvant radiotherapy (RT), immunotherapy (pembrolizumab) and chemotherapy for lymph node-positive, triple negative (TN) or hormone receptor positive/HER2-negative breast cancer. The names of the study interventions involved in this study are: * Radiation Therapy (RT) * Immunotherapy: Pembrolizumab (MK-3475) * Chemotherapies: * Paclitaxel * Doxorubicin (also called Adriamycin) * Cyclophosphamide * Carboplatin (optional, and in TN only) * Capecitabine (optional, and in TN only)

Research Team

Laura M Spring, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adults with lymph node-positive, non-metastatic breast cancer that's either triple negative or high-risk HR+/HER2-negative. Participants must have a primary tumor ≥1.5 cm, good organ function, and an ECOG score of 0 or 1. They should plan to have surgery after chemotherapy and be willing to use contraception.

Inclusion Criteria

I am planned to receive specific chemotherapy before surgery.

I plan to have breast surgery with or without reconstruction after chemotherapy.

My cancer is present in multiple locations within the same organ.

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Exclusion Criteria

I have had radiation therapy on the same side of my chest before.

I have not received a live vaccine in the last 30 days.

I cannot undergo radiation therapy due to health reasons.

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Treatment Details

Interventions

Capecitabine (Chemotherapy)
Cyclophosphamide (Chemotherapy)
Doxorubicin (Chemotherapy)
Paclitaxel (Chemotherapy)
Pembrolizumab (Immunotherapy)
Radiation Therapy Boost (Radiation)

Trial OverviewThe study tests combining neoadjuvant radiotherapy with immunotherapy (Pembrolizumab) and various chemotherapies (Paclitaxel, Doxorubicin, Cyclophosphamide; Carboplatin and Capecitabine are optional for TN). It aims to evaluate the effectiveness of this treatment regimen before surgery.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Group C (High Dose RT Boost)Experimental Treatment7 Interventions

High-dose RT boost plus pembrolizumab followed by pembrolizumab plus paclitaxel, doxorubicin and cyclophosphamide chemotherapy. There will be up to a total of 8 cycles of pembrolizumab (4 cycle before surgery and 4 cycles after surgery at the discretion of the study doctor).

Group II: Group B (Low Dose RT Boost)Experimental Treatment7 Interventions

Low-dose RT boost plus pembrolizumab, followed by pembrolizumab plus paclitaxel, doxorubicin and cyclophosphamide chemotherapy. There will be up to a total of 8 cycles of pembrolizumab (4 cycle before surgery and 4 cycles after surgery at the discretion of the study doctor).

Group III: Group A (No RT Boost)Experimental Treatment6 Interventions

No RT boost plus pembrolizumab, followed by pembrolizumab plus paclitaxel, doxorubicin and cyclophosphamide chemotherapy.There will be up to a total of 8 cycles of pembrolizumab (4 cycle before surgery and 4 cycles after surgery at the discretion of the study doctor).

Capecitabine is already approved in Canada, Japan for the following indications: