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

NCT06450314 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2025-02-20

No results posted yet for this study

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?

Conditions

Interventions

DRUG

Discontinuation 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

DEVICE

Monitoring 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).

Sponsors & Collaborators

  • Natera, Inc.

    collaborator INDUSTRY

  • UNICANCER

    lead OTHER

Principal Investigators

  • Thibault De la Motte Rouge, MD · Centre Eugene Marquis

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-25
Primary Completion
2027-12-15
Completion
2029-12-15

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

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 NCT06450314 on ClinicalTrials.gov