Status:

UNKNOWN

Relevance of T Lymphocytes Tumor Infiltrates CD8 and Foxp3 as Immune Prognostic Biomarker in Breast Cancer Treated by Neo Adjuvant Chemotherapy

Lead Sponsor:

Centre Georges Francois Leclerc

Conditions:

Breast Cancer

Eligibility:

FEMALE

18-80 years

Phase:

NA

Brief Summary

Neoadjuvant chemotherapy is standard therapy for the management of localised breast cancer, and makes it possible to evaluate tumour response. Achieving pathological complete response (pCR) after chem...

Eligibility Criteria

Inclusion

  • inclusion criteria
  • Signed informed consent
  • Social security coverage
  • Age between 18 and 80 years
  • Histologically proven breast cancer, regardless of histological type or molecular subtype (triple negative, hormone-receptor positive, HER2+++), including inflammatory forms
  • Localised breast cancer with or without axillary or subclavicular lymph node involvement
  • Absence of bone or visceral metastasis on further evaluation (bone scintigraphy, chest X-ray, abdominal echocardiography or CT scan of the thorax, abdomen and pelvic area)
  • Treatment by neoadjuvant chemotherapy (treatment protocol at physician's discretion)
  • Patient amenable to receiving adjuvant therapy (chemotherapy, radiotherapy, hormone therapy, targeted therapy)
  • Breast surgery (breast-sparing or not) planned after neoadjuvant chemotherapy
  • exclusion criteria
  • Metastatic breast cancer
  • Neoadjuvant radiotherapy
  • Patient not amenable to surgery
  • Ongoing therapy for any other type of cancer
  • Legal incapacity (incarceration or persons under legal guardianship)
  • Patient unable to sign the informed consent or unable to attend medical follow-up for geographical, social or mental reasons.

Exclusion

    Key Trial Info

    Start Date :

    May 1 2012

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 1 2025

    Estimated Enrollment :

    500 Patients enrolled

    Trial Details

    Trial ID

    NCT01513408

    Start Date

    May 1 2012

    End Date

    October 1 2025

    Last Update

    October 17 2023

    Active Locations (1)

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    CGFL

    Dijon, France, 21079