OncoMatch/Clinical Trials/NCT06450314
Decreasing Treatment for Metastatic HER2-Positive Breast Cancer With Undectable Cancer Levels in Blood Tests.
Is NCT06450314 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Discontinuation of the anti-HER2 maintenance therapy and Monitoring with signatera test for metastatic breast cancer.
Treatment: Discontinuation of the anti-HER2 maintenance therapy · Monitoring with signatera test — 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?
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) 3+ immunohistochemical overexpression (3+)
HER2-positive is defined as HER2 3+ immunohistochemical overexpression
Required: HER2 (ERBB2) amplification
HER2-positive is defined as...the presence of HER2 amplification, according to ASCO-CAP guidelines
Disease stage
Required: Stage LOCALLY ADVANCED INOPERABLE, IV
Metastatic disease required
locally advanced inoperable or metastatic histologically-proven HER2-positive breast cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: HER2-targeted therapy (trastuzumab, pertuzumab, trastuzumab deruxtecan, T-DM1) — any line, locally advanced inoperable or metastatic
Patient must have received continuous anti-HER2 targeted therapy (including Trastuzumab, Trastuzumab/Pertuzumab, Trastuzumab-Deruxtecan or T-DM1) treatment for at least 2 years in any line setting, for their locally advanced inoperable or metastatic HER2 + breast cancer (prior treatment interruption of 3 months maximum is allowed), with complete response or partial response at last radiological assessment
Lab requirements
Blood counts
adequate haematological function according to guidelines hospital
Kidney function
adequate renal function according to guidelines hospital
Liver function
adequate hepatic function according to guidelines hospital
Cardiac function
adequate cardiac function according to guidelines hospital
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06450314 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received HER2-targeted therapy.
Does this trial require ERBB2?
Yes, ERBB2 3+ immunohistochemical overexpression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 amplification is a required biomarker for enrollment.
What disease stage is eligible?
Stage LOCALLY ADVANCED INOPERABLE or IV is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages