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

Institut du Cancer de Montpellier - Val d'Aurelle

Status: Completed

Conditions: Breast Cancer

Treatments: Biological: Blood sample

Study type: Interventional

Funder types: Other

Identifiers

NCT03255486

ICM2013/12

Details and patient eligibility

About

Biomarkers of resistance to neoadjuvant chemotherapy in locally advanced breast cancer

Full description

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

Enrollment: 164 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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164 participants in 1 patient group

Blood sample

Experimental group

Description:

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).

Treatment:

Biological: Blood sample