IRB #

STUDY00017461

Title

[NCI CIRB] A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with ≥ 1 CM Residual Invasive Cancer or Positive Lymph Nodes (ypN+) After Neoadjuvant Chemotherapy

Principal Investigator

Zahi Mitri

Study Purpose

This randomized phase III trial studies how well pembrolizumab works in treating triple-negative breast cancer. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.

Medical Condition(s)

Triple Receptor Negative Breast Cancer

Eligibility Criteria

Men or Women 18 years or older
Confirmed ER-, PR- and HER2- (triple-negative, TNBC) invasive breast cancer
Must have had preoperative (neoadjuvant) chemotherapy followed by surgery
Must not have had prior immunotherapy with anti-PD-L1, anti-CTLA4 or similar drugs

Age Range

18 - 120

Healthy Volunteers Needed

No

Duration of Participation

10 years

Minors Included

No

Contact

Knight Cancer Institute Clinical Trials
trials@ohsu.edu
503 494-1080

Sponsor

SWOG

Recruitment End

11/30/2030

Compensation Provided

No


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