Pembrolizumab for Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen byBora Lim, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?This phase II trial studies how well pembrolizumab works in treating patients with hormone receptor positive inflammatory breast cancer that has not spread to other parts of the body, who are receiving hormone therapy and did not achieve a pathological complete response to chemotherapy. 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.

Eligibility Criteria

This trial is for patients with hormone receptor positive inflammatory breast cancer that hasn't spread, who didn't fully respond to chemotherapy and are on hormone therapy. Eligible participants must have a certain level of neutrophils, not be pregnant or become pregnant, have started radiation or endocrine therapy recently if applicable, and meet specific health criteria like normal organ function tests.

Inclusion Criteria

Is willing and able to provide written informed consent for the trial

Participants of reproductive potential must agree to avoid becoming pregnant or impregnating a partner

I am 18 years old or older.

+10 more

Exclusion Criteria

Is currently participating in a study of an investigational anti-cancer agent

I have an immune system disorder or am on drugs that weaken my immune system.

I have an autoimmune disease that needed treatment in the last 3 months.

+13 more

Participant Groups

The trial is testing pembrolizumab's effectiveness in these patients. Pembrolizumab is an immunotherapy drug that may boost the immune system's ability to fight cancer by blocking tumor growth. This phase II study will assess how well it works when other treatments haven't led to complete cancer removal.

1Treatment groups

Experimental Treatment

Group I: Treatment (pembrolizumab)Experimental Treatment1 Intervention

Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸 Approved in United States as KEYTRUDA for: