Testing Pembrolizumab as Additional Therapy for Triple-Negative Breast Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT02954874

This study is exploring whether the drug pembrolizumab can help improve outcomes for patients with triple-negative breast cancer when given after initial chemotherapy. The trial aims to see if pembrolizumab can prevent cancer from returning and improve survival rates.

Patient Parameters

Program Overview

This clinical trial is investigating the effectiveness of pembrolizumab, an immunotherapy drug, in treating patients with triple-negative breast cancer. Pembrolizumab may help the immune system attack cancer cells and prevent them from growing and spreading. The study will compare patients who receive pembrolizumab after chemotherapy to those who do not, to see if it improves disease-free survival and overall survival.

Description

The main goal of this study is to see if pembrolizumab can help patients with triple-negative breast cancer live longer without the cancer coming back. Patients who have at least 1 cm of cancer left after chemotherapy or have cancer in their lymph nodes are eligible. The study will also look at how pembrolizumab affects overall survival and the time until cancer spreads to other parts of the body.

Participants will be randomly assigned to one of two groups. One group will receive pembrolizumab through an IV every 42 days for a year, while the other group will be monitored without additional treatment. All participants may receive radiation therapy and will have regular follow-ups for up to 10 years.

The study will also collect blood and tissue samples for future research. Patients will be monitored for side effects and how well they tolerate the treatment. The study will also explore how pembrolizumab affects quality of life and long-term health outcomes.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with triple-negative breast cancer or low estrogen receptor-positive/HER2 borderline breast cancer.
  • Have at least 1 cm of cancer remaining after chemotherapy or cancer in the lymph nodes.
  • No signs of cancer spreading to other parts of the body.
  • Completed chemotherapy and surgery with clear margins.
  • Willing to provide tissue samples for research.
  • Aged 18 or older with a performance status of 2 or less.
  • No history of severe lung inflammation or active autoimmune disease requiring treatment in the past 2 years.
  • Not pregnant or breastfeeding and willing to use contraception during the study.
  • No active infections or recent live vaccinations.
  • Meet specific blood count and organ function criteria.
  • Agree to follow study procedures and attend follow-up visits.

Locations

FACILITYZIPCITYSTATE
University of Alabama at Birmingham Cancer Center35233BirminghamAlabama
Southern Cancer Center PC-Daphne36526DaphneAlabama
Southern Cancer Center PC-Mobile36607MobileAlabama
Southern Cancer Center PC-Providence36608MobileAlabama
Southern Cancer Center PC-Springhill36608MobileAlabama
University of South Alabama Mitchell Cancer Institute36688MobileAlabama
Alaska Oncology and Hematology LLC99508AnchorageAlaska
Anchorage Oncology Centre99508AnchorageAlaska
Katmai Oncology Group99508AnchorageAlaska
Providence Alaska Medical Center99508AnchorageAlaska

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