RecruitingPhase 2NCT06450314

Decreasing Treatment for Metastatic HER2-Positive Breast Cancer With Undectable Cancer Levels in Blood Tests.

De-escalation of Medical Therapies in HER2-positive Metastatic Breast Cancer in Long-term Persistent Response and Minimal Residual Disease Undetectable in Circulating Tumor DNA

Sponsor

UNICANCER

Enrollment

170 participants

Start Date

Jan 25, 2025

Study Type

INTERVENTIONAL

Conditions

Metastatic Breast Cancer HER2-positive Breast Cancer

Summary

Heroes is a multicentre, national, non-randomized, open-label, phase 2 study. The goal of this clinical trial is to evaluate the feasibility of therapeutic de-escalation in HER2-positive metastatic breast cancer with disease controlled after 2 years of maintenance treatment with anti-HER2 targeted therapy AND ctDNA negative testing. The main question it aims to answer is : • Is it possible to identify patients for whom temporary or permanent discontinuation of treatment is possible without impacting prognosis?

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether patients with HER2-positive metastatic breast cancer who have undetectable cancer in their blood (circulating tumor DNA negative) can safely reduce their treatment intensity. The study explores de-escalation of therapy — giving less treatment when cancer signals disappear from blood tests. **You may be eligible if...** - You are 18 or older - You have locally advanced or metastatic HER2-positive breast cancer confirmed by biopsy - You have had a blood test (liquid biopsy) showing undetectable circulating tumor DNA - You have tumor tissue available for molecular testing **You may NOT be eligible if...** - Your blood test still shows detectable circulating tumor DNA - You have not previously received HER2-targeted therapy 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

DRUGDiscontinuation of the anti-HER2 maintenance therapy

Heroes is a de-escalation study. Patient must have received continuous anti-HER2 targeted therapy (including Trastuzumab, Trastuzumab/Pertuzumab, Trastuzumab-Deruxtecan, T-DM1) for at least 2 years in any line setting for their HER2-positive metastatic breast cancer with complete response or partial response at last radiological assessment. Patients with ctDNA negative test at baseline will stop their anti-HER2 targeted therapy during the study

DEVICEMonitoring with signatera test

ctDNA test will be performed at 1.5 month after inclusion and every 3 months during 2 years. Note: For the ctDNA negative patients who become ctDNA positive: ctDNA test will be performed once, 3 months after restarting treatment (+/-1 week).