Capecitabine + Cemiplimab for Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen byAixa E Soyano Muller, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a single-center, open-label, phase I study to assess the safety and efficacy of the oral chemotherapy capecitabine in combination with cemiplimab in patients with hormone-receptor-positive (HR+) metastatic breast cancer.

Research Team

Aixa E Soyano Muller, MD

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

This study is for adults with hormone-receptor-positive, HER2-negative metastatic breast cancer. Participants must have a performance status of 0-2, indicating they are fully active or capable of self-care. They should not have used PD-1/PD-L1 inhibitors like cemiplimab before and must be free from certain other treatments and conditions that could affect the trial's safety or results.

Inclusion Criteria

Participants must be willing and able to comply with the protocol for the duration of the study. This compliance includes undergoing treatment, scheduled visits, and examinations, including follow-up

I can take care of myself and am up and about more than half of my waking hours.

My breast cancer is noninvasive, hormone-receptor positive, and either locally advanced or metastatic.

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Exclusion Criteria

Participation in another clinical study with an investigational product during the last 4 weeks

Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study

Patient is currently pregnant or breast feeding

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Treatment Details

Interventions

Capecitabine (Anti-metabolites)
Cemiplimab (Monoclonal Antibodies)

Trial OverviewThe trial tests how safe and effective the combination of capecitabine (oral chemotherapy) and cemiplimab (an immune therapy drug) is in treating metastatic breast cancer. It's an early-phase study where all participants receive both drugs to see if they work better together.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Dose Level 2Experimental Treatment2 Interventions

Cemiplimab 350mg + Capecitabine 1000 mg/m\^2

Group II: Dose Level 1Experimental Treatment2 Interventions

Cemiplimab 350mg + Capecitabine 800 mg/m\^2

Capecitabine is already approved in Canada, Japan for the following indications: