Decreasing Treatment for Metastatic HER2-Positive Breast Cancer With Undectable Cancer Lev
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 neg
| Condition(s) | Metastatic Breast Cancer, HER2-positive Breast Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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? |
| Who can participate | Inclusion Criteria: 1. Patient must have signed a written informed consent prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in signing the patient's consent; 2. Men or women ≥18 years of age; 3. Documented diagnosis of locally advanced inoperable or metastatic histologically-proven HER2-positive breast cancer (HER2-positive is defined as HER2 3+ immunohistochemical overexpression, or the presence of HER2 amplification, according to ASCO-CAP guidelines); 4. Must have an adequate archival tumor tissue sample available for next-generation sequencing (NGS) analysis by central laboratory, in order to design the ctDNA test (based on most rece |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | UNICANCER |
| Locations | Rennes, France |
| Start date | 2025-01-25 |
| NCT ID | NCT06450314 |
| Official listing | https://clinicaltrials.gov/study/NCT06450314 |