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Completed

NCT Number: NCT03255486

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

Biomarkers of resistance to neoadjuvant chemotherapy in locally advanced breast cancer

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut régional du Cancer de Montpellier

Montpellier, 34298, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Blood sample

Biological

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 outcomes

  1. predictive molecular abnormalities assessment

    Time frame: up to 5 years

    Highlighting and study of predictive molecular abnormalities of resistance to neoadjuvant chemotherapy in locally advanced breast cancer

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Sponsors and collaborators

Lead sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Other

Registry information

Official study title

Identification and Evaluation of Biomarkers of Resistance to Neoadjuvant Chemotherapy and Establishment of Preclinical Models of Resistance in Locally Advanced Breast Cancer

Acronym: IDEASEIN

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Aug 21, 2017
Registry last updated
Aug 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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