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NCT03377387 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center.

Active
Registry status
Phase 1
Development phase
34
Enrollment target
10
Study locations

NCT03377387: Active Phase 1 study of Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center.

NCT03377387 is a Phase 1 study of Breast Cancer that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 34 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 10 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03377387, a Phase 1 study of Breast Cancer, is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
34 participants
Enrollment target
10
Study locations

Study Summary

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.

Conditions Studied

Breast Cancer

Interventions

  • DRUG Capecitabine
  • DRUG Neratinib
  • BEHAVIORAL EORTC QLQ - BR23, EQ-5D-5L, EORTC QLQ-C30

Study Locations (10)

New York

  • Memorial Sloan Kettering Commack - Commack
  • Memorial Sloan Kettering Westchester - Harrison
  • Memorial Sloan Kettering Cancer Center - New York
  • Memorial Sloan Kettering Nassau - Uniondale

New Jersey

  • Memorial Sloan Kettering at Basking Ridge - Basking Ridge
  • Memorial Sloan Kettering Monmouth - Middletown
  • Memorial Sloan Kettering Bergen - Montvale

Connecticut

  • Hartford Healthcare Cancer Institute @ Hartford Hospital - Hartford

Florida

  • Baptist Alliance - McI - Miami

Pennsylvania

  • Lehigh Valley Health Network - Allentown

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2017-12-13
Est. Completion 2026-12
Phase Phase 1

Sponsor

Memorial Sloan Kettering Cancer Center

1,884 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03377387

The ClinicalTrials.gov registry entry for NCT03377387 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 1,884 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Capecitabine is the first listed.

NCT03377387 reports 10 study locations spanning 5 distinct geographic areas - top geographies include New York, New Jersey, Connecticut.

Frequently Asked Questions

What is clinical trial NCT03377387 about?

NCT03377387 is a clinical study titled "Capecitabine 7/7 Schedule With Neratinib in Patients With Metastatic HER2-Positive Breast Cancer". 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 ...

What is the current status of trial NCT03377387?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2017-12-13. Estimated completion is 2026-12.

What conditions does trial NCT03377387 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT03377387?

The interventions under investigation include: Capecitabine (DRUG), Neratinib (DRUG), EORTC QLQ - BR23, EQ-5D-5L, EORTC QLQ-C30 (BEHAVIORAL).

Who is sponsoring clinical trial NCT03377387?

This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03377387 being conducted?

This trial has 10 study locations across Connecticut, Florida, New Jersey, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Read our methodology - how this data is sourced, computed, and verified.
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.