Identification and Evaluation of Biomarkers of Resistance to Neoadjuvant Chemotherapy (IDEA SEIN)

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Biological: Blood sample

• Registration Number: NCT03255486
• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

Brief Summary

Biomarkers of resistance to neoadjuvant chemotherapy in locally advanced breast cancer

Detailed Description

Identification and evaluation of biomarkers of resistance to neoadjuvant chemotherapy and establishment of preclinical models of resistance in locally advanced breast cancer

Study Timeline

• Study Start: 2013-07
• Status Verified: 2016-09
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Study First Submitted: 2017-08-10
• Study First Submitted QC: 2017-08-16
• Last Update Submitted: 2017-08-16
• Study First Posted: 2017-08-21
• Last Update Posted: 2017-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 164

Inclusion Criteria

• proven invasive breast adenocarcinoma (cytology and / or biopsy).

  • locally advanced stage (tumor size greater than 2 cm).
  • neoadjuvant chemotherapy indication validated RCP
  • Patient eligible for neoadjuvant chemotherapy.
  • Performance Index according to WHO or less 1.
  • Patient aged 18 years and older.
  • Being affiliated to a social security scheme or an equivalent scheme of social protection
  • Obtaining signed informed consent, and that before any specific prequalification testing.

Exclusion Criteria

• presence of metastatic disease at diagnosis.

  • Breast Cancer inflammatory.
  • rare histologic subtypes (non ductal lobular and not).
  • Other cancer (except basal cell skin carcinoma and cancer of the cervix in situ adequately treated and curative) treated in the previous 5 years.
  • Patient pregnant or nursing or of childbearing age without effective contraception.
  • Breast cancer in men.
  • legal incapacity or limited legal capacity. medical or psychological conditions allowing the subject to complete the study or to sign the consent (art. L.1121-6, L.1121-7, L.1211-8, L1211-9).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blood sample	Blood sample	Blood samples will be taken by venipuncture during the initial assessment (4 tubes of 5 ml at diagnosis and 3 tubes of 5 ml to the following) These blood tests will be repeated after the first course, at the end of neoadjuvant chemotherapy and after surgery and will be carried out jointly to levies motivated by the balance sheet or the treatment of CS to avoid additional puncture. These samples will allow us to study the profiles of circulating tumor DNA, and miRNA tumor proteins (proteomics study).

Primary Outcome Measures

Name	Time	Method
predictive molecular abnormalities assessment	up to 5 years	Highlighting and study of predictive molecular abnormalities of resistance to neoadjuvant chemotherapy in locally advanced breast cancer

Trial Locations

Locations (1)

Institut régional du Cancer de Montpellier; 🇫🇷 Montpellier, France