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Tucatinib, Trastuzumab, and Capecitabine With SRS for Brain Metastases From HER-2 Positive Breast Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE1

Tucatinib, Trastuzumab, and Capecitabine With SRS for Brain Metastases From HER-2 Positive Breast Cancer

Phase 1 Trial of Tucatinib, Trastuzumab, and Capecitabine With Stereotactic Radiosurgery (SRS) in Patients With Brain Metastases From HER-2 Positive Breast Cancer

NCT05553522•Baptist Health South Florida

View on ClinicalTrials.gov

Summary

This research study will evaluate how well brain metastases associated with HER-2 positive breast cancer can be controlled using a type of radiation known as stereotactic radiosurgery (SRS) when combined with three therapeutic agents, tucatinib, capecitabine, and trastuzumab. The combined use of SRS with the three drugs is considered investigational.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histologically confirmed HER-2 -positive breast cancer with newly-diagnosed brain metastases.
•2. ECOG Performance Status (PS) of 0, 1, 2
•3. Patients with 1-10 brain metastases will be candidates for tucatinib, capecitabine, and trastuzumab with SRS at the discretion of the treating radiation oncologist. Intra-cranial brain metastasis must measure 3 cm or less in the greatest dimension
•4. Age 18 years or greater and being willing and able to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures
•5. Life expectancy at least 12 weeks
•6. Any number of prior systemic therapies will be allowed, except tucatinib and capecitabine.
•7. Hemoglobin ≥ 9g/dL, White blood count ≥3.0 × 10\^9/ L , Absolute Granulocyte count ≥1.5x 10\^9/ L and platelet count ≥100 × 10\^9/ L.
•8. Serum bilirubin ≤ 1.5 × ULN
•9. AST and / or ALT \<= 2 × ULN (≤ 5 × ULN when clearly attributable to the presence of liver metastases)
•10. Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance \> 60mL/min
+22 more criteria

Exclusion Criteria

•1. Patients with leptomeningeal metastases documented by MRI or CSF evaluation
•2. Evidence of intra-tumoral or peri-tumoral hemorrhage deemed significant by the treating physician
•3. Brain metastases within 5 mm of the optic chiasm or optic nerve
•4. Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom, e.g., Crohn's disease, malabsorption, or CTCAE grade \>2 diarrhea of any etiology at baseline
•5. History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina, myocardial infarction, arrhythmia, New York Heart Association (NYHA) functional classification of 3 or 4
•6. Unable to undergo brain MRI
•7. Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C
•8. All toxicities from prior therapies must have resolved to CTCAE v 5.0 grade 1 or better by the time of study enrollment
•9. Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection, uncontrolled diabetes, second active malignancy) that could cause unacceptable safety risks or compromise compliance with the protocol
•10. Currently receiving other investigational cancer therapy within 4 weeks prior to start of study treatment with the exception of continuing therapy with GnRH analogues
+10 more criteria

Locations (1)

Miami Cancer Institute at Baptist Health, Inc.

Miami, Florida, United States

Key Dates

Start Date

January 29, 2024

Primary Completion Date

December 17, 2025

Completion Date

December 17, 2025

Last Updated

December 31, 2025

Enrollment

ACTUAL participants

Conditions

Brain MetastasesHER2-positive Breast Cancer

Interventions

Combined use of SRS with Tucatinib, Trastuzumab, and Capecitabine

COMBINATION_PRODUCT

Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

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Brain MetastasesNonsmall Cell Lung Cancer Stage III

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RECRUITINGPHASE1/PHASE2

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Advanced Solid TumorAdvanced Malignant Neoplasm+28 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: December 31, 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 With SRS for Brain Metastases From HER-2 Positive Breast Cancer

Inclusion Criteria

Exclusion Criteria

Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers

A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer

Comparison of Molecular-Genetic Concordance of the Primary Tumor and Brain Metastases of Gastroesophageal Cancers

Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements