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Tucatinib, Trastuzumab, and Capecitabine for the Treatment of HER2+ LMD | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

A Phase II Non-randomized Study to Assess the Safety and Efficacy of the Combination of Tucatinib and Trastuzumab and Capecitabine for Treatment of Leptomeningeal Metastases in HER2 Positive Breast Cancer

NCT03501979•University of Alabama at Birmingham

View on ClinicalTrials.gov

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.

Detailed Description

The purpose of this study is to evaluate a new treatment for patients with HER2+ metastatic breast cancer (MBC) with leptomeningeal disease (LMD). This is a rare and fast-growing form of cancer. Leptomeningeal disease refers to the seeding of tumor cells to the leptomeninges and dissemination in the cerebrospinal fluid. Currently, there are is no standard of care treatment for LMD. However, we think the combination therapy will be safe and well-tolerated and may also improve survival. Blood and spinal fluid samples will be collected to evaluate the effects on the body and the cancer, which will help provide greater understanding to therapy response in patients. The study has a two-stage design with the first stage including 15 subjects from up to ten institutions nationwide. If it advances to the second stage based on the number of successes, another 15 subjects will be enrolled.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Men and women, age ≥18 years at time of consent
•Histologically proven metastatic infiltrating carcinoma of the breast that is HER2 positive - Immunohistochemistry (IHC) 3+ and/or Fluorescence in situ hybridization (FISH) ratio \>2.0, or average HER2 copy number \>6.0 signals per cell or per current ASCO-CAP (American Society of Clinical Oncology - College of American Pathologists) or NCCN (National Comprehensive Cancer Network) guidelines. (NOTE: HER2 testing may be performed on primary and/or metastatic site; Any estrogen and progesterone \[ER/PR\] status is allowed.)

Exclusion Criteria

•Karnofsky Performance Status ≥ 50 or Eastern Cooperative Oncology Group (ECOG) ≤ 3
•Patient is able and willing to undergo study-required testing including:
•1. Contrast-enhanced MRI Note: If patient has implants in place that are MRI incompatible, these must be removed prior to enrollment.
•2. Placement of an Ommaya reservoir (ventricular access device). Note: This is mandatory for the first 15 patients enrolled onto the protocol (first stage). In the second stage, this is strongly recommended per protocol. If a patient cannot or chooses not to undergo Ommaya placement in the second stage, the patient will be allowed to enroll.
•3. Evaluation by medical oncologist at baseline and at every cycle (required)
•4. Evaluation by neurologist/neuro-oncologist at baseline and at every cycle (strongly recommended); if this is not possible at a site, a medical oncologist may per perform the protocol specified evaluations at each visit.
•Patients who are on steroids due to CNS disease or LMD diagnosis should be on a stable dose for at least 5 days prior to registration.
•Prior treatment allowances are as follows:
•1. \>14 days since last dose of any previous endocrine therapy, chemotherapy, trastuzumab or other antibody-based therapy. NOTE: If patients have been previously receiving trastuzumab on a weekly basis (at a dose of 2mg/kg), only a 7 day washout will be required.
•2. \>14 days or five half-lives since previous treatment with any experimental agent, whichever is greater
+30 more criteria

Locations (9)

University of Alabama at Birmingham

Birmingham, Alabama, United States

UCSF-Mission Bay

San Francisco, California, United States

MedStar Georgetown University-Lombardi CCC

Washington D.C., District of Columbia, United States

University of Chicago

Chicago, Illinois, United States

Indiana University-Melvin and Bren Simon cancer center

Indianapolis, Indiana, United States

Dana Farber/Harvard Cancer Center-

Boston, Massachusetts, United States

University of Michigan-

Ann Arbor, Michigan, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

University of Washington Medical Center-Montlake

Seattle, Washington, United States

Key Dates

Start Date

February 20, 2019

Primary Completion Date

June 22, 2021

Completion Date

June 22, 2021

Last Updated

August 29, 2025

Enrollment

ACTUAL participants

Conditions

Metastatic Breast CancerLeptomeningeal Disease

Interventions

Tucatinib

DRUG

Trastuzumab

DRUG

Capecitabine

DRUG

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Solid Tumor, AdultMetastatic Breast Cancer+9 more

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RECRUITINGPHASE2

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Advanced Breast CancerMetastatic Breast Cancer+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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