NCT04720729: MONDRIAN

Chemotherapy Monitoring by ctDNA in HER2- Metastatic Breast Cancer

Terminated Phase 2 Last updated 22 June 2025

What this trial tests

Phase 2 trial testing Chemotherapy monitoring by circulating tumor DNA analysis in HER2-negative Metastatic Breast Cancer in 160 participants. Terminated before completion.

Timeline

21 April 2021

Primary endpoint
21 April 2025

21 April 2025

Quick facts

Lead sponsor	Institut Curie
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	160
Start date	21 April 2021
Primary completion	21 April 2025
Estimated completion	21 April 2025
Sites	1 location across France

Drugs / interventions tested

• Chemotherapy monitoring by circulating tumor DNA analysis — full drug profile →

Conditions studied

• HER2-negative Metastatic Breast Cancer — all drugs for HER2-negative Metastatic Breast Cancer →

Sponsor

Institut Curie — full company profile →

Who can join

18 and older, female only, with HER2-negative Metastatic Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Neutrophil extracellular traps formed during chemotherapy confer treatment resistance via TGF-β activation.
   Mousset A, Lecorgne E, Bourget I, Lopez P, et al · · 2023 · cited 210× · PMID 37037615 · DOI 10.1016/j.ccell.2023.03.008
2. Clinical Utility of Liquid Biopsy-Based Actionable Mutations Detected via ddPCR.
   Palacín-Aliana I, García-Romero N, Asensi-Puig A, Carrión-Navarro J, et al · · 2021 · cited 38× · PMID 34440110 · DOI 10.3390/biomedicines9080906
3. Liquid biopsy into the clinics: Current evidence and future perspectives.
   Boukovala M, Westphalen CB, Probst V. · · 2024 · cited 29× · PMID 40027149 · DOI 10.1016/j.jlb.2024.100146
4. Fulvestrant and everolimus efficacy after CDK4/6 inhibitor: a prospective study with circulating tumor DNA analysis.
   Vasseur A, Cabel L, Hego C, Takka W, et al · · 2024 · cited 18× · PMID 38413796 · DOI 10.1038/s41388-024-02986-6
5. Liquid biopsy in breast cancer: Redefining precision medicine.
   Schiavone ML, Scarpitta R, Ravera F, Bleve S, et al · · 2025 · cited 3× · PMID 40740670 · DOI 10.1016/j.jlb.2025.100312
6. Circulating Tumor DNA in Early and Metastatic Breast Cance-Current Role and What Is Coming Next.
   Tegeler CM, Hartkopf AD, Banys-Paluchowski M, Krawczyk N, et al · · 2024 · cited 2× · PMID 39682108 · DOI 10.3390/cancers16233919
7. Evaluating the clinical utility of ctDNA testing to identify molecular cancer progression - lessons from SERENA-6.
   Taranto E, DeMichele A. · · 2026 · PMID 41611725 · DOI 10.1038/s41523-026-00894-4