RecruitingPhase 1NCT06162559

Neoadjuvant Trastuzumab, Pertuzumab and Tucatinib Without Chemotherapy in HER2-positive Breast Cancer: the TRAIN-4 Study


Sponsor

The Netherlands Cancer Institute

Enrollment

30 participants

Start Date

Dec 18, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single-center, phase 1b study evaluating the safety and feasibility of a neoadjuvant treatment with tucatinib, trastuzumab and pertuzumab in stage II-IIIA HER2-positive breast cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether HER2-positive breast cancer patients can be effectively treated before surgery with targeted therapy (trastuzumab, pertuzumab, and tucatinib) alone — without any chemotherapy. It aims to determine if some patients can avoid the side effects of chemotherapy while still achieving complete tumor elimination. **You may be eligible if...** - You are 18 or older with newly diagnosed HER2-positive breast cancer (confirmed by biopsy) - Your tumor is large enough to require pre-surgery (neoadjuvant) treatment - Your general health is adequate and heart function is normal - You have not started any treatment for this cancer yet **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic) - You have had prior treatment for breast cancer - You have significant heart disease or reduced heart function - You are pregnant or breastfeeding - You have conditions that interfere with absorbing oral medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTucatinib

Tucatinib 300mg is taken orally twice daily

DRUGTrastuzumab

Trastuzumab 6mg/kg is administered intravenously on day 1 (loading dose 8mg/kg) or subcutaneously 600mg on day 1 of each cycle

DRUGPertuzumab

Pertuzumab 420mg is administered intravenously on day 1 (loading dose 840mg) or subcutaneously 600mg/kg (loading dose 1200mg) on day 1 of each cycle


Locations(1)

Netherlands Cancer Institute

Amsterdam, Netherlands

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NCT06162559


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