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

This phase III trial compares the effect of continuation of treatment with pembrolizumab (usual approach) to observation only at preventing cancer from coming back in patients with early-stage triple-negative breast cancer (TNBC) who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. The usual approach for patients with early-stage TNBC who receive preoperative chemotherapy plus pembrolizumab is to continue to receive pembrolizumab for up to 27 weeks after surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help

Trial Details

NCT ID
NCT05812807
Phase
PHASE3
Sponsor
Alliance for Clinical Trials in Oncology
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • Pembrolizumab
  • Patient Observation
  • Biopsy
  • Biospecimen Collection
  • Questionnaire Administration
  • Quality-of-Life Assessment
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Fairhope, Alabama, United States|30.52297,-87.90333
  • Mobile, Alabama, United States|30.69436,-88.04305
  • Mobile, Alabama, United States|30.69436,-88.04305
  • Anchorage, Alaska, United States|61.21806,-149.90028

Key Eligibility Criteria

  • Age \>= 18 years
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  • Triple Negative Breast Cancer:
  • Patients with a history of clinical stage T1cN1-2 or T2-4N0-2 (clinical stage II or III prior to preoperative therapy) breast cancer at time of dia…

For full eligibility, visit ClinicalTrials.gov.

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