Pembrolizumab for Triple-Negative Breast Cancer

Recruiting at 1052 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Lajos Pusztai

Principal Investigator

SWOG Cancer Research Network

Eligibility Criteria

This trial is for adults with triple-negative breast cancer who've completed neoadjuvant chemotherapy and surgery, have no metastatic or recurrent disease, and no active hepatitis or infections. They must not be pregnant/nursing, have had certain prior treatments (like anti-HER2 therapies), live vaccines recently, or autoimmune diseases treated in the last 2 years.

Inclusion Criteria

My cancer has not spread to distant parts of my body.

Your platelet count is at least 100,000 per microliter.

Site must verify that there is no known change in the step 1 eligibility since initial registration

Exclusion Criteria

I am not HER2-positive according to specific cancer guidelines.

My cancer is weakly ER/PR positive and I'm not eligible for hormone therapy.

My cancer has not returned in the same place it was treated.

Treatment Details

Interventions

• Pembrolizumab (Checkpoint Inhibitor)

Trial Overview The study tests Pembrolizumab as an additional treatment after standard therapy for triple-negative breast cancer. It's a phase III trial to see if this immunotherapy can prevent cancer from returning by helping the immune system attack remaining cancer cells.

Participant Groups

Group I: Arm II (pembrolizumab) Experimental Treatment 6 Interventions

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.

Group II: Arm I (observation) Experimental Treatment 6 Interventions

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.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+