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

Metastatic Breast Cancer Clinical Trial

Official title: 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

Status Not yet recruiting

Clinical Trial 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?

Clinical Trial Description

Metastatic breast cancer remains a difficult disease to cure in the majority of cases. Improved biological knowledge has made it possible to separate these heterogeneous pathologies into several subtypes. For the HER2 subtype, which accounts for around 15% of breast cancers, very significant progress has been made in recent years with innovative treatments known as anti-HER2 therapies (trastuzumab, pertuzumab, T-DM1, T-DXd). Long-term disease control has been achieved in at least 20% of these patients with these new treatments.

However, the treatments are continued indefinitely, impacting patients' quality of life through toxicity and chronic administration. It is possible that, for some patients, these treatments can be discontinued while maintaining surveillance. To assess this possibility, new biological tools, notably the search for circulating tumor DNA (ctDNA), look very promising for detecting any tumor cells in the body, even to very small traces (minimal residual disease).

The primary objective of this trial is to evaluate the feasibility of therapeutic de-escalation (temporary or complete discontinuation) in patients with HER2-positive metastatic breast cancer whose disease is controlled after 2 years of maintenance treatment with anti-HER2 targeted therapy AND a negative ctDNA test. ;

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2-positive Breast Cancer
• Metastatic Breast Cancer

• NCT number: NCT06450314
• Study type: Interventional
• Source: UNICANCER
• Contact: Clara Guyonneau, PharmD
• Phone: +33 (0) 1 44.23.04.65
• Email: c-guyonneau@unicancer.fr
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: November 15, 2024
• Completion date: November 15, 2029