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Circulating Tumor DNA After Neoadjuvant Chemotherapy
Sponsor: Institut Bergonié
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.
Official title: Detection of Circulating Tumoral DNA Mutations (Sequential Assessment) Following Neoadjuvant Chemotherapy for Breast Cancer: Clinical Validity (ALIENOR Study)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2017-10-06
Completion Date
2028-10
Last Updated
2025-10-02
Healthy Volunteers
No
Conditions
Interventions
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).
Locations (1)
Institut Bergonie
Bordeaux, France