Monitoring chemotherapy effectiveness using ctDNA in HER2-negative metastatic breast cancer
Chemotherapy Monitoring by Circulating Tumor DNA (ctDNA) in HER2 (Human Epidermal Growth Factor Receptor-2)- Metastatic Breast Cancer (MONDRIAN): a Phase 2 Study
This study tests if measuring tumor DNA in the blood can help doctors make better treatment decisions for patients with HER2-negative metastatic breast cancer starting a second round of chemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 214 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Institut Curie Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Paris) |
| Trial ID | NCT04720729 on ClinicalTrials.gov |
What this trial studies
This phase II interventional study focuses on patients with HER2-negative metastatic breast cancer who are starting a second line of chemotherapy. Participants will undergo blood draws to detect circulating tumor DNA (ctDNA) at baseline and day 15 of the treatment cycle. The study aims to assess ctDNA levels to inform treatment decisions, with recommendations made by a Steering Executive Board based on ctDNA changes. If ctDNA is successfully detected and deemed informative, patients may receive tailored treatment recommendations for subsequent therapy cycles.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with advanced HER2-negative metastatic breast cancer who are eligible for a second line of chemotherapy.
Not a fit: Patients with isolated CNS progression, concurrent severe medical conditions, or those not eligible for second line chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective chemotherapy regimens for patients with metastatic breast cancer.
How similar studies have performed: While the use of ctDNA for monitoring treatment response is gaining traction, this specific approach in HER2-negative metastatic breast cancer is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Paris
- Institut Curie — Paris, France (Recruiting)
Study contacts
- Study coordinator: Cécile Simondi
- Email: drci.promotion@curie.fr
- Phone: +33 1 56 24 56 36
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.