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NCT05812807Possibly a fitRecruiting

Pembrolizumab versus monitoring after triple-negative breast cancer response

Anatomic Stage II Breast Cancer AJCC v8Early Stage Triple-Negative Breast CarcinomaAnatomic Stage IIIA Breast Cancer AJCC v8Anatomic Stage IIIB Breast Cancer AJCC v8

Treatments studied

Part of Cancer, Women’s health & pregnancy clinical trials.

This trial checks whether giving pembrolizumab (an immunotherapy) after surgery helps people with triple-negative breast cancer reduce the chance of the cancer coming back, compared with close monitoring only. It’s for patients who had no remaining invasive cancer after neoadjuvant chemotherapy plus pembrolizumab.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 3
Enrollment
1,295 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • You are age 18 or older.
  • Your breast cancer is triple-negative (ER and PR are 10% or less, and HER2 is negative).
  • After neoadjuvant chemotherapy plus pembrolizumab and surgery, there is no remaining invasive cancer in the breast or lymph nodes (DCIS is allowed).
  • You completed at least 6 cycles of chemotherapy with pembrolizumab, and finished all chemotherapy before surgery.
  • You must be within 12 weeks of finishing surgery before enrolling, and you must have acceptable blood counts and organ lab results.
  • You must not be pregnant or nursing (and if you could become pregnant, you need a recent negative pregnancy test).

View the official record on ClinicalTrials.gov

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