Targeting the Best Treatment for Early Triple-Negative Breast Cancer After Surgery

Recruiting · Phase 3 · Anatomic Stage II Breast Cancer AJCC v8 and related conditions · 49 states

Check if I qualify View on ClinicalTrials.gov

About this trial

This study looks at how well continuing treatment with pembrolizumab works compared to just keeping an eye on things in patients with early-stage triple-negative breast cancer. These patients had a complete response after receiving chemotherapy and pembrolizumab before surgery. The goal is to see if observation alone is as effective as continuing pembrolizumab for 27 weeks after surgery to help prevent the cancer from coming back.

This is a Phase 3 trial, meaning it is looking at how well the treatment works and how safe it is. The trial is not regulated by the FDA as a drug. About 1,295 participants are expected to take part.

Who can join

Adults aged 18 and older can join this trial. It is open to both men and women with early-stage triple-negative breast cancer who had no invasive disease left after treatment. Other specific health criteria must also be met. The trial team will confirm who can join.

Conditions

Anatomic Stage II Breast Cancer AJCC v8, Early Stage Triple-Negative Breast Carcinoma, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8

Age group

Adult, Older adult

Sex

All sexes

The study team makes the final call on eligibility.

What happens in the study

Participants are placed into two groups by chance. One group will receive pembrolizumab through an IV for 27 weeks. The other group will simply be observed for the same time. Both groups will have tumor biopsies and blood samples taken, as well as imaging tests like mammograms or MRIs during follow-up.