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Chemotherapy Monitoring by ctDNA in HER2- Metastatic Breast Cancer

NCT04720729 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-06-22

No results posted yet for this study

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 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

  • HER2-negative Metastatic Breast Cancer

Interventions

BIOLOGICAL

Chemotherapy monitoring by circulating tumor DNA analysis

During the screening step (2nd chemotherapy line, cycle 1) : at each time point (L2C1D1 \& L2C1D15), 30 ml of blood will be drawn on special tubes with conservative suited for ctDNA analyses (e.g. STRECK® tubes).Then cell-free circulating DNA (cfcDNA) will be extracted from plasma following the manufacturer recommendations. cfcDNA will be quantified, and minimum 500-1000 copies will be analyzed by droplet digital PCR (ddPCR). Analyses will define if ctDNA could be detected during L2. For the interventional step, from L3 (3rd chemotherapy line) : 20 ml of blood will be drawn at L3C1D1 and L3C1D15. If ctDNA at D15 shows a major drop (\> 40%) from D1, treatment will be continued. If ctDNA at D15 shows no major drop from D1, chemotherapy will be changed.

Sponsors & Collaborators

  • Institut Curie

    lead OTHER

Principal Investigators

  • François-Clément BIDARD, PR · INSTITUT CURIE - Medical Oncology

  • Steven LE GOUILL, PR, MD · INSTITUT CURIE - Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-21
Primary Completion
2025-04-21
Completion
2025-04-21

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04720729 on ClinicalTrials.gov