Circulating Tumor DNA After Neoadjuvant Chemotherapy — ALIENOR  

Breast Cancer Clinical Trial

Official title: Detection of Circulating Tumoral DNA Mutations (Sequential Assessment) Following Neoadjuvant Chemotherapy for Breast Cancer: Clinical Validity (ALIENOR Study)

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Patients with an invasive breast cancer on neoadjuvant chemotherapy (with the exception of cT2cN0 tumors) are preselected before the surgical procedure. They are definitely included during the post-surgery visit following the analysis of the surgical specimen (only patients whose tumor did not achieve a complete pathological response are included).

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). ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT03357120
• Study type: Interventional
• Source: Institut Bergonié
• Contact: Hervé BONNEFOI, MD, PhD
• Phone: +33 5 56 33 32 69
• Email: h.bonnefoi@bordeaux.unicancer.fr
• Status: Recruiting
• Phase: N/A
• Start date: October 6, 2017
• Completion date: October 2024