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Clinical trialNCT03377387Active, not recruitingPhase 1/PHASE2Interventional

Capecitabine 7/7 Schedule With Neratinib in Patients With Metastatic HER2-Positive Breast Cancer

SponsorMemorial Sloan Kettering Cancer CenterEnrollment34Breast Cancer
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This is a phase l/II study. The purpose of this study is to test the safety of the study drug neratinib in combination with a standard chemotherapy drug called capecitabine at different doses to find out what effects, if any, it has on people. Capecitabine (Xeloda®) is approved by the Food and Drug Administration (FDA) for advanced breast cancer treatment. Neratinib is an investigational drug, meaning the FDA has not approved the use of this drug for advanced breast cancer. The combination of capecitabine and neratinib has been studied before in another study where capecitabine was administered using the standard dosing schedule. In this study, the investigators want to find out if a different dosing schedule of capecitabine combined with neratinib is safer. This different dosing schedule is experimental, meaning the administration schedule of capecitabine and neratinib is not FDA approved for treatment for HER2 positive advanced breast cancer.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

10 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Hartford Healthcare Cancer Institute @ Hartford Hospital

    Hartford, Connecticut, United States

  • Baptist Alliance - Mci

    Miami, Florida, United States

  • Memorial Sloan Kettering at Basking Ridge

    Basking Ridge, New Jersey, United States

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, United States

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, United States

  • Memorial Sloan Kettering Commack

    Commack, New York, United States

  • Memorial Sloan Kettering Westchester

    Harrison, New York, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, United States

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, United States

  • Lehigh Valley Health Network

    Allentown, Pennsylvania, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
13 Dec 2017
Primary completion
31 Dec 2026
Completion
31 Dec 2026
Last update posted
16 Apr 2026
Registered enrollment
34
Registry id
NCT03377387

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.