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Tucatinib, Trastuzumab, and Capecitabine for the Treatment of HER2+ LMD

NCT03501979 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-08-29

Study results available
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Summary

A phase 2 non-randomized study to assess the safety and efficacy of the combination of tucatinib and trastuzumab with capecitabine for the treatment of leptomeningeal metastases in HER2-neu positive breast cancer.

Conditions

Interventions

DRUG

Tucatinib

Tucatinib study drug is given in tablet form and taken daily.

DRUG

Trastuzumab

Trastuzumab is approved by the FDA and is available commercially. Trastuzumab must be prepared and is administered intravenously.

DRUG

Capecitabine

Capecitabine is approved by the FDA and is available commercially as an oral drug.

Sponsors & Collaborators

Principal Investigators

  • Erica M Stringer-Reasor, MD · University of Alabama at Birmingham

  • Rashmi K Murthy, MD, MBE · M.D. Anderson Cancer Center

  • Barbara J O'Brien, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-20
Primary Completion
2021-06-22
Completion
2021-06-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03501979 on ClinicalTrials.gov