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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03255486
Acronym
IDEASEIN
Enrollment
164
Registered
2017-08-21
Start date
2013-07-31
Completion date
2016-12-31
Last updated
2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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

Interventions

BIOLOGICALBlood 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).

Sponsors

Institut du Cancer de Montpellier - Val d'Aurelle
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
predictive molecular abnormalities assessmentup to 5 yearsHighlighting and study of predictive molecular abnormalities of resistance to neoadjuvant chemotherapy in locally advanced breast cancer

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026