Clinical trial · Interventional
Chemotherapy Monitoring by ctDNA in HER2- 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): insufficient recruitment
Summary
Brief summary (as posted)
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 detection. Patients for whom ctDNA was successfully detected and found informative by the study executive board could then be included in the interventional step when starting a new line of therapy. ctDNA will be quantified using the customized test, at baseline and day 15 (+/- 3 working day) of cycle #1, and results will be made available before the cycle 2 Day 1, together with a treatment management recommendation by the Study Executive Board (continuation or discontinuation of the corresponding chemotherapy)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2-negative Metastatic Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy monitoring by circulating tumor DNA analysis | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm
- description
- Patients with HER2-negative metastatic breast cancer, starting a second line of chemotherapy
- interventionNames
- Biological: Chemotherapy monitoring by circulating tumor DNA analysis
Primary outcomes (7)
- measure
- L3C1 : ctDNA quantification
- timeFrame
- At the Day 1 of Cycle 1 (each cycle is 21 days)
- description
- ctDNA quantification (Mutant Allelic Frequency (MAF) %) during 3rd chemotherapy Line, 1st cycle (L3C1)
- measure
- L3C1 : ctDNA quantification
- timeFrame
- At the Day 15 of Cycle 1 (each cycle is 21 days)
- description
- ctDNA quantification (Mutant Allelic Frequency (MAF) %) during 3rd chemotherapy Line, 1st cycle (L3C1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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