Capecitabine + Neratinib for Breast Cancer

Recruiting at9 trial locations

Overseen by Chau Dang, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing the safety of combining two drugs, neratinib and capecitabine, in a new dosing schedule for patients with advanced breast cancer. The goal is to find out if this new schedule is safer and more effective. Neratinib blocks proteins that help cancer grow, and capecitabine stops cancer cells from multiplying.

Research Team

Chau Dang, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults with stage IV HER2-positive metastatic breast cancer who've had trastuzumab-based therapy. They can have up to four prior chemo treatments in the metastatic setting but not neratinib with capecitabine. Stable brain lesions are okay, and they must have a good heart function (LVEF ≥50%) and be able to perform daily activities (ECOG 0-1). Women must use effective contraception.

Inclusion Criteria

I have had previous cancer treatments, including neratinib and capecitabine.

My cancer can be measured or not, according to RECIST v1.1 standards.

I've had up to 4 chemotherapy treatments and trastuzumab but not neratinib for my metastatic cancer.

Exclusion Criteria

My heart's electrical cycle is longer than normal or I've had specific heart rhythm issues.

Pregnant patients or currently breast-feeding

I have not had a fever over 101.3°F or any unexplained infection in the last 2 weeks.

Treatment Details

Interventions

• Capecitabine (Anti-metabolites)
• Neratinib (Tyrosine Kinase Inhibitor)

Trial Overview The study tests the safety of neratinib combined with capecitabine at different doses in patients with advanced breast cancer. Capecitabine is FDA-approved; neratinib isn't yet approved for this use. The focus is on whether changing the dosing schedule can improve safety compared to standard schedules.

Participant Groups

Group I: capecitabine 7/7 with neratinib Experimental Treatment 3 Interventions

In the phase I portion of the study, a 3+3 design will be used. Once the MTD is reached, the phase II portion will enroll up to 24 patients. Capecitabine will be taken orally in AM and PM (at the assigned dose per cohort) 7 days on and 7 days off. Neratinib is given as 240 mg daily continuously without stopping. A cycle is 28 days. Patients will be seen on Day 1 of each cycle (+/- 3 days). The MD has been determined as 240mg of neratinib and 1000mg BID of capecitabine.

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

Approved in Canada as Xeloda for:

• Colorectal cancer
• Breast cancer

Approved in Japan as Xeloda for:

• Colorectal cancer
• Breast cancer

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Lisa M. DeAngelis

Memorial Sloan Kettering Cancer Center

Chief Medical Officer since 2021

MD from Columbia University

Selwyn M. Vickers

Memorial Sloan Kettering Cancer Center

Chief Executive Officer since 2022

MD from Johns Hopkins University

Puma Biotechnology, Inc.

Industry Sponsor

Trials

58

Recruited

10,100+