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

Sponsor
UNICANCER
Study ID
NCT06450314
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Discontinuation of the anti-HER2 maintenance therapy — DRUG
    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
  • Monitoring with signatera test — DEVICE
    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).

Study Details

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?

Key Dates

First listed
Jun 10, 2024
Start date
Jan 25, 2025
Status verified
Jul 2026
Primary completion
Dec 15, 2027
Completion
Dec 15, 2029

Study Design

Enrollment
170 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ctDNA negative cohort at baseline
    Patients with ctDNA negative test at baseline will stop their anti-HER2 targeted therapy during the study * In case of radiological progression with or without ctDNA positive test, prior treatment will be restarted or new anti-HER2 treatment will be initiated according investigator choice * In case of ctDNA positive test without radiological progression, prior treatment will be restarted.

Primary Outcome Measure

Progression-free rate [ Time Frame: 1 year ]

Central Contacts

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