Status:
TERMINATED
Chemotherapy Monitoring by ctDNA in HER2- Metastatic Breast Cancer
Lead Sponsor:
Institut Curie
Conditions:
HER2-negative Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This is a one-arm, single site, open-label phase II study. Patients will be enrolled in the screening step at the start of the second line of chemotherapy, and will undergo blood draws for ctDNA detec...
Detailed Description
Patients will be enrolled in the screening step at the start of the second line of chemotherapy, and will undergo blood draws for ctDNA detection: That second line of treatment will be managed by cli...
Eligibility Criteria
Inclusion
- Inclusion criteria :
- Written informed consent
- Woman ≥ 18 years old
- Performance status 0-2
- Advanced HER2-negative metastatic breast cancer on the last tumor tissue assessed (ASCO-CAP (College of American Pathologists) guidelines)
- Eligible to a second line of chemotherapy for MBC (Metastatic Breast Cancer)
- Evaluable disease (per RECIST v1.1)
- Organ functions compatible with the use of chemotherapies (as decided by the investigator)
- No isolated CNS progression or leptomeningeal carcinomatosis
- No concurrent stage IV malignancy
- No concurrent severe and/or uncontrolled medical or psychological condition that would contraindicate participation in this study
- Additional criteria for the screening step :
- Presence of a known somatic mutation deemed trackable in circulating cell-free DNA. If the tumoral genetic landscape is unknown at inclusion, its characterization should be requested (or ongoing) at inclusion
- Additional criteria for the interventional step :
- Satisfactory ctDNA detection and changes during the 2nd line, as determined by the Study Executive Board (SEB)
- Patient eligible to a third line of chemotherapy
- Exclusion criteria :
- none
Exclusion
Key Trial Info
Start Date :
April 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2025
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04720729
Start Date
April 21 2021
End Date
April 21 2025
Last Update
June 22 2025
Active Locations (1)
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1
Institut Curie
Paris, France, 75005