Testing MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer

Conditions

• Breast Carcinoma In Situ
• Invasive Breast Carcinoma
• Stage I Breast Cancer AJCC v7
• Stage II Breast Cancer AJCC v6 and v7
• Stage III Breast Cancer AJCC v7
• Triple-Negative Breast Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo collection of blood samples
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Patient Observation — OTHER
  Undergo standard monitoring
• Pembrolizumab — BIOLOGICAL
  Given IV
• Quality-of-Life Assessment — OTHER
  Ancillary studies
• Questionnaire Administration — OTHER
  Ancillary studies
• Radiation Therapy — RADIATION
  Undergo radiation therapy

Study Details

This randomized phase III trial studies how well pembrolizumab works in treating patients with triple-negative breast cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Key Dates

Start date

Jan 18, 2017

Status verified

Jun 2026

Primary completion

Aug 31, 2026

Completion

Aug 31, 2026

Study Design

Enrollment

1,155 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (observation)
  Patients receive no treatment but are monitored at standard clinical intervals during first year after randomization. Patients are examined every 12 weeks for 1 year, every 6 months for 4 years, and then annually for 5 years. Patients may undergo radiation therapy within 12 weeks of last breast cancer operation or after treatment. Patients may also undergo collection of blood samples throughout the trial.
• Experimental: Arm II (pembrolizumab)
  Patients receive pembrolizumab IV over 30 minutes on days 1 and 22. Cycles repeat every 42 days for 52 weeks in the absence of disease progression or unacceptable toxicity. Patients may undergo radiation therapy within 12 weeks of last breast cancer operation or after treatment. Patients may also undergo collection of blood samples throughout the trial.

Primary Outcome Measure

Invasive disease-free survival (IDFS) [ Time Frame: From date of randomization to date of first invasive recurrence, second invasive primary cancer (breast or not), or death due to any cause, assessed up to 10 years ]

Locations (895)

Related coverage on Hipa.ai

• Pembrolizumab Phase 3 Trial for Triple-Negative Breast Cancer Reaches Primary…
  Pembrolizumab · May 31, 2026 · ClinicalTrials.gov

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