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

Breast Cancer Clinical Trial

— IDEASEIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03255486
• Other study ID #: ICM2013/12
• Status: Completed
• Phase: N/A
• First received: August 10, 2017
• Last updated: August 16, 2017
• Start date: July 2013
• Est. completion date: December 2016

Study information

• Verified date: September 2016
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Biomarkers of resistance to neoadjuvant chemotherapy in locally advanced breast cancer

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Biological:
• 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).

Locations

Country	Name	City	State
France	Institut régional du Cancer de Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	predictive molecular abnormalities assessment	Highlighting and study of predictive molecular abnormalities of resistance to neoadjuvant chemotherapy in locally advanced breast cancer	up to 5 years