Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Complete Response After Chemotherapy and Pembrolizumab

Sponsor: Alliance for Clinical Trials in Oncology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05812807

Provider View

This study is comparing the effects of continuing pembrolizumab treatment versus just monitoring patients who have early-stage triple-negative breast cancer and have shown no signs of cancer after initial chemotherapy and pembrolizumab treatment.

Patient Parameters

Program Overview

This phase III clinical trial is investigating whether continuing treatment with pembrolizumab or simply observing patients is more effective in preventing the return of cancer in individuals with early-stage triple-negative breast cancer who have had a complete response to initial chemotherapy combined with pembrolizumab. Pembrolizumab is an immunotherapy drug that may help the immune system attack cancer cells and stop them from growing and spreading. The study aims to find out if just monitoring patients is as effective as continuing pembrolizumab in preventing cancer recurrence after surgery.

Description

The main goal of this study is to see if just observing patients who have had a complete response to chemotherapy and pembrolizumab is as effective as continuing pembrolizumab in keeping cancer from coming back. Researchers will also compare the quality of life between those who continue pembrolizumab and those who are just observed. They will look at the social and financial impacts of reducing additional treatment.

Secondary goals include evaluating how observation versus continued pembrolizumab affects recurrence-free survival, overall survival, and the rate of side effects. The study will also assess the impact on quality of life and financial costs for patients.

Exploratory goals involve tracking changes in quality of life and financial impacts over time, and developing a measure of value from the patient's perspective.

Participants will be randomly assigned to one of two groups after completing initial chemotherapy and pembrolizumab treatment, followed by surgery:

  • Group 1 (Pembrolizumab): Patients will continue to receive pembrolizumab through an IV. They will also have tumor biopsies and blood samples taken during the study and follow-up.
  • Group 2 (Observation): Patients will be monitored without additional pembrolizumab treatment. They will also have tumor biopsies and blood samples taken during the study and follow-up.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
  • Diagnosed with triple-negative breast cancer, with specific staging criteria.
  • No remaining invasive cancer in the breast or lymph nodes after initial treatment.
  • Must have completed at least 6 cycles of chemotherapy with pembrolizumab before surgery.
  • Surgery must have been completed within 12 weeks before joining the study.
  • Must not be pregnant or nursing, and women of childbearing potential must have a negative pregnancy test.
  • Must have adequate blood cell counts and organ function.
  • Must be willing to provide tumor tissue samples.
  • Patients with other cancers that do not interfere with the study are eligible.
  • Patients with controlled HIV on treatment are eligible.

Exclusion Criteria

  • No stage IV breast cancer.
  • No history of invasive breast cancer in either breast, except for ductal carcinoma in situ (DCIS).
  • No active liver disease or intolerance to pembrolizumab.
  • No need for chronic systemic steroids or immunosuppressive medications.
  • Must be willing and able to comply with study requirements.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.