Circulating Tumor DNA After Neoadjuvant Chemotherapy

Not Applicable

Recruiting

• Conditions: Breast Cancer
• Interventions: Other: Follow-up after neoadjuvant chemotherapy

• Registration Number: NCT03357120
• Lead Sponsor: Institut Bergonié

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 2017-10-06
• Status Verified: 2017-11
• Study First Submitted: 2017-11-09
• Study First Submitted QC: 2017-11-28
• Last Update Submitted: 2017-11-28
• Study First Posted: 2017-11-29
• Last Update Posted: 2017-11-29
• Primary Completion: 2022-10
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Follow-up after neoadjuvant chemotherapy	Follow-up after neoadjuvant chemotherapy	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).

Primary Outcome Measures

Name	Time	Method
Prognostic value of the presence of ctDNA mutation(s) measured by dPCR on recurrence-free interval (RFI) at 3 years.	3 years

Secondary Outcome Measures

Name	Time	Method
Prognostic value of the presence of ctDNA mutation(s) on a single sample assessment after surgery (measured by dPCR) on RFI at 3 years.	3 years
Prognostic value of the presence of ctDNA mutation(s) on a single sample assessment after surgery (measured by dPCR) on RFI at 5 years.	5 years
Prognostic value of the presence of ctDNA mutation(s) on overall survival (OS) at 3 years.	3 years
Prognostic value of the presence of ctDNA mutation(s) on OS at 5 years.	5 years
Prognostic value of the presence of ctDNA mutation(s) on distant-metastasis-free interval (DRFI) at 3 years.	3 years
Prognostic value of the presence of ctDNA mutation(s) on a single sample assessment after surgery (measured by dPCR) on DRFI at 3 years.	3 years
Prognostic value of the presence of ctDNA mutation(s) on a single sample assessment after surgery (measured by dPCR) on DRFIat 5 years.	5 years
Prognostic value of the presence of ctDNA mutation(s) on DRFI at 5 years.	5 years

Trial Locations

Locations (1)

Institut Bergonie; 🇫🇷 Bordeaux, France