Study on Pre-Surgery Pembrolizumab and Radiation Therapy for Breast Cancer (P-RAD)

Sponsor: Laura M. Spring, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04443348

Provider View

This clinical trial is exploring a new treatment approach for breast cancer that involves using a combination of radiation therapy, immunotherapy (pembrolizumab), and chemotherapy before surgery. The study focuses on patients with specific types of breast cancer that have spread to the lymph nodes.

Patient Parameters

Program Overview

The purpose of this study is to find the best dose of radiation therapy when combined with pembrolizumab and chemotherapy for treating breast cancer that has spread to the lymph nodes. The study will evaluate if this combination can enhance the immune system's ability to fight cancer. Participants will undergo screening, receive study treatments, and have follow-up visits. The study will test the effectiveness of pembrolizumab with or without radiation therapy directed at the breast tumor. After this, participants will receive chemotherapy with pembrolizumab, followed by surgery and possibly additional treatments like radiation or hormone therapy. Participants will be randomly assigned to one of three groups and will be informed of their group before starting treatment. The study will last up to 13 months, with follow-up for two years. A total of 120 people are expected to participate. Pembrolizumab is not yet approved for this specific use but is approved for other conditions. The chemotherapies used are FDA-approved.

Description

The main goal of this study is to determine the best dose of radiation therapy to use with pembrolizumab and chemotherapy before surgery for breast cancer. The study will see if this combination can help the immune system better attack cancer cells. Participants will be screened for eligibility and will receive study treatments, including evaluations and follow-up visits. The study will test the effectiveness of pembrolizumab with or without radiation therapy aimed at the breast tumor. Participants will then receive chemotherapy with pembrolizumab, followed by surgery and possibly additional treatments like radiation or hormone therapy. Participants will be randomly assigned to one of three groups, and neither they nor their doctor will choose the group. However, they will be informed of their group before starting treatment. The study will last up to 13 months, with follow-up for two years. A total of 120 people are expected to participate. Pembrolizumab is not yet approved for this specific use but is approved for other conditions. The chemotherapies used are FDA-approved.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have non-metastatic breast cancer that is either triple-negative or hormone receptor-positive/HER2-negative, with cancer spread to lymph nodes.
  • Primary breast tumor must be at least 1.5 cm in size.
  • Cancer must be confirmed in the lymph nodes by biopsy.
  • Must have clips or markers placed in the tumor and lymph nodes.
  • Can have multiple tumors, but only one will receive pre-surgery radiation.
  • No signs of cancer spread to distant parts of the body.
  • Plan to receive chemotherapy before surgery.
  • Plan to have breast-conserving surgery or mastectomy after chemotherapy.
  • Must have good overall health with a performance status score of 0 or 1.
  • Must have adequate organ function based on specific blood tests.
  • Women must not be pregnant or breastfeeding and must agree to use contraception during the study and for four months after the last dose of pembrolizumab.
  • Men must agree to use contraception and not donate sperm during the study and for four months after the last dose.
  • Must be willing to follow the study schedule and procedures.
  • Must agree to a research biopsy of the breast tumor during the study.
  • Must provide written informed consent to participate.

Exclusion Criteria

  • Have HER2-positive breast cancer.
  • Have inflammatory or metastatic breast cancer.
  • Have conditions that prevent breast-conserving therapy or mastectomy.
  • Have had prior radiation therapy to the breast or chest.
  • Have had another invasive cancer in the last five years, except for certain skin cancers or cervical cancer.
  • Have active tuberculosis or have received certain immune therapies before.
  • Have had recent systemic anti-cancer therapy or major surgery without full recovery.
  • Have a history of lung inflammation requiring steroids.
  • Have severe allergies to pembrolizumab or its ingredients.
  • Have active autoimmune diseases, except for certain stable conditions.
  • Have conditions that could interfere with the study or are not in the best interest of the participant.
  • Have a known history of HIV or active hepatitis B or C.
  • Have received a live vaccine recently.
  • Have had an organ transplant.
  • Women who test positive for pregnancy before starting the study.
  • Use of certain medications that suppress the immune system, except for specific allowed uses.

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