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Circulating Tumor DNA After Neoadjuvant Chemotherapy

NCT03357120 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-10-02

No results posted yet for this study

Summary

Trial assessing the prognostic value of ctDNA mutations from samples taken sequentially in patients with invasive breast cancer initially treated with neoadjuvant chemotherapy and whose tumor is not in complete histological response.

Conditions

Interventions

OTHER

Follow-up after neoadjuvant chemotherapy

Sequential plasma samples for ctDNA mutations analysis will be taken during the post-surgery visit (within 2-5 weeks after surgery) and every 6 months (+/- 1 month) thereafter for 5 years. In case of relapse patients will be proposed to participate to an optional research program with a blood test for ctDNA assessment and biopsies from a metastasis (when these biopsies are clinically indicated). Next Generation Sequencing (NGS) analysis will be performed on post-neoadjuvant chemotherapy residual tumor tissue samples. The mutations identified by NGS in residual tumor will be tracked in ctDNA using personalized digital PCR (dPCR) or by an NGS technique whose bioinformatics pipeline is adapted to the analysis of ctDNA. In case of relapse patients will be proposed to participate to an optional research program with a blood test for ctDNA assessment and biopsies from a metastasis (when these biopsies are clinically indicated).

Sponsors & Collaborators

  • Fondation Bergonié

    collaborator UNKNOWN

  • Institut Bergonié

    lead OTHER

Principal Investigators

  • Hervé BONNEFOI, MD, PhD · Institut Bergonié

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-06
Primary Completion
2026-10-31
Completion
2028-10-31

Countries

  • France

Study Locations

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Entities

Diseases

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 NCT03357120 on ClinicalTrials.gov