Relevance of T Lymphocytes Tumor Infiltrates CD8 and Foxp3 as Immune Prognostic Biomarker in Breast Cancer Treated by Neo Adjuvant Chemotherapy (PRIMUNEO)
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|ClinicalTrials.gov Identifier: NCT01513408|
Recruitment Status : Completed
First Posted : January 20, 2012
Last Update Posted : October 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Other: immunohistochemical detection of lymphocytes T CD8+/Foxp3 ratio||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||May 2012|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
patient suffering from non-metastatic breast cancer
Other: immunohistochemical detection of lymphocytes T CD8+/Foxp3 ratio
For each patients included the study, a tumour block from the initial biopsy, as well as a representative block of residual tumour (area of complete tumoral regression, area of partial tumoral regression or area of unmodified residual tumour) will be chosen by the initial pathologist in each investigating centre. Once the pathologist has verified the concordance between the images observed on the blocks sent from the investigating centres, and the associated pathology reports, immunohistochemical analysis will be performed on the slides prepared from each block.
- Overall survival [ Time Frame: From date of inclusion up to the end of follow-up period : december 2014 (anticipated) ]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.
- Recurrence-free survival [ Time Frame: From inclusion up to the end of follow up period: december 2014 ]Recurrence-free survival is defined as the time interval from the date of surgery to the date of first recurrence (loco-regional or metastatic) or to death (all causes). Patients alive without recurrence will be censored on the date of last follow-up.
- Pathological complete response [ Time Frame: After surgery ]Pathological complete response on the surgically resected specimen is defined as the absence of any evidence of invasive carcinoma in the breast or dissected axillary lymph nodes.
- PathIm score (pathological-immunological) [ Time Frame: From inclusion up to the end of surgery for all patients: december 2014 (anticipated) ]PathIm score (pathological-immunological)from 0 to 2, defining three patient groups with different prognoses (0 = good prognosis; 1 = intermediate prognosis; 2 = unfavourable prognosis), and defined as the sum of the pathology information regarding the extent of residual tumour according to the pAJCC score(pAJCC stage≤IIA = 0; pAJCC stage>IIA = 1), and the immunological information from the CD8/Foxp3 ratio (high CD8 AND low Foxp3 infiltration = 0, all other situations = 1)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01513408
|Dijon, France, 21079|
|Principal Investigator:||Sylvain LADOIRE, MD||Centre Georges Francois Leclerc|