Actively Recruiting
Decreasing Treatment for Metastatic HER2-Positive Breast Cancer With Undectable Cancer Levels in Blood Tests.
Led by UNICANCER · Updated on 2025-02-20
170
Participants Needed
1
Research Sites
255 weeks
Total Duration
On this page
Sponsors
U
UNICANCER
Lead Sponsor
N
Natera, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Decreasing Treatment for Metastatic HER2-Positive Breast Cancer With Undectable Cancer Levels in Blood Tests.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient must have signed a written informed consent or have a trusted person sign if unable
- Men or women aged 18 years or older
- Confirmed diagnosis of locally advanced inoperable or metastatic HER2-positive breast cancer
- Adequate archival tumor tissue sample available for ctDNA test design
- Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of 1 or less
- Received continuous anti-HER2 targeted therapy for at least 2 years with complete or partial response
- If bone disease only, must have complete metabolic response in 18-FDG PET scan
- Treated and controlled primary tumor
- Patients with ER-positive disease may have received endocrine therapy which must continue if present
- Adequate cardiac, renal, hematological, and hepatic functions
- Negative pregnancy test within 28 days before inclusion for women of childbearing potential
- Women and fertile men agree to use adequate contraception; hormonal contraceptives not allowed if hormone receptor positive
- Willing and able to comply with study procedures and follow-up
- Affiliated with a Social Security System or equivalent
You will not qualify if you...
- Any breast cancer progression over the past 2 years or at study entry
- Using other antineoplastic agents besides trastuzumab, pertuzumab, Trastuzumab-Deruxtecan, T-DM1, or endocrine therapy
- History of tumoral meningitis or active central nervous system metastases requiring corticosteroids or anticonvulsants
- Untreated or symptomatic brain metastases, or those treated with whole brain radiotherapy
- Major concurrent diseases affecting heart, liver, kidneys, blood system, or other clinically important conditions
- History of other breast cancers unless both tumors confirmed HER2-positive
- Prior other malignancies unless disease-free and treatment completed for at least 3 years
- Major surgery within 2 weeks before study entry
- Pregnant or breastfeeding women
- Unwilling or unable to comply with medical follow-up due to social or psychological reasons
- Participation in another clinical study with conflicting procedures within 28 days
- Persons deprived of liberty or under guardianship
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Centre Eugène marquis
Rennes, France, 44229
Actively Recruiting
Research Team
C
Clara Guyonneau, PharmD
CONTACT
T
Thibault De la Motte Rouge, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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