Pembrolizumab and Carboplatin in Treating Patients With Circulating Tumor Cells Positive Metastatic Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen byMassimo Cristofanilli, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Northwestern University

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of the study is to evaluate the impact on progression-free survival (PFS) with the combination carboplatin - pembrolizumab in patients with CTC (circulating tumor cells) positive, HER2 negative metastatic breast cancer previously treated with anthracyclines and taxanes. Previous studies have indicated that recurrent breast cancers are more resistant to chemotherapy and maybe associated with a weak immune system. This study is investigating the use of an immune therapy drug, pembrolizumab, that has the ability to restore the capacity of controlling and killing cancer cells of an important component of your immune system called T-cells. Pembrolizumab has been found effective in other types of cancer and has already been approved by FDA for those indications, but the efficacy in breast cancer is still unknown. In this study, pembrolizumab will be combined with chemotherapy to increase the cancer cell killing. There is no control or placebo treatment in this study.

Eligibility Criteria

Inclusion Criteria

You have triple negative breast cancer and have not had chemotherapy for advanced cancer.

Your breast cancer does not have high levels of a protein called HER-2, based on specific testing guidelines.

Female subject of childbearing potential (FOCBP) should have a negative urine or serum pregnancy within 7 days prior to registration; and must be repeated within 3 days (72 hours) prior to first dose of study drug; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

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Exclusion Criteria

You have a current case of tuberculosis.

Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device < or equal to 28 days of registration

If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy

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Treatment Details

Interventions

Carboplatin (Alkylating agents)
Pembrolizumab (Monoclonal Antibodies)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (pembrolizumab, carboplatin)Experimental Treatment3 Interventions

Patients receive pembrolizumab IV over 30 minutes on day 1 and carboplatin IV over 30-60 minutes on day 1 beginning with course 3. Courses repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.

Carboplatin is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Paraplatin for: