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Prospective Study of the Relevance of T Lymphocytes Tumor Infiltrates CD8 and Foxp3 as a New imMUne Prognostic Biomarker in Breast Cancer Treated by NEOadjuvant Chemotherapy


N/A
18 Years
80 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Prospective Study of the Relevance of T Lymphocytes Tumor Infiltrates CD8 and Foxp3 as a New imMUne Prognostic Biomarker in Breast Cancer Treated by NEOadjuvant Chemotherapy

Inclusion Criteria


inclusion criteria

1. Signed informed consent

2. Social security coverage

3. Age between 18 and 80 years

4. Histologically proven breast cancer, regardless of histological type or molecular
subtype (triple negative, hormone-receptor positive, HER2+++), including inflammatory
forms

5. Localised breast cancer with or without axillary or subclavicular lymph node
involvement

6. 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)

7. Treatment by neoadjuvant chemotherapy (treatment protocol at physician's discretion)

8. Patient amenable to receiving adjuvant therapy (chemotherapy, radiotherapy, hormone
therapy, targeted therapy)

9. Breast surgery (breast-sparing or not) planned after neoadjuvant chemotherapy

exclusion criteria

1. Metastatic breast cancer

2. Neoadjuvant radiotherapy

3. Patient not amenable to surgery

4. Ongoing therapy for any other type of cancer

5. Legal incapacity (incarceration or persons under legal guardianship)

6. Patient unable to sign the informed consent or unable to attend medical follow-up for
geographical, social or mental reasons.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Overall survival

Outcome Description:

Overall survival is defined as the time from inclusion date to death from any cause, or to date of last follow-up, if death does not occur.

Outcome Time Frame:

From date of inclusion up to the end of follow-up period : december 2014 (anticipated)

Safety Issue:

No

Principal Investigator

Sylvain LADOIRE, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Georges Francois Leclerc

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

2011-1SLa-01

NCT ID:

NCT01513408

Start Date:

May 2012

Completion Date:

December 2014

Related Keywords:

  • Breast Cancer
  • breast cancer
  • CD8+
  • Foxp3
  • neoadjuvant chemotherapy
  • Breast Neoplasms

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