This is a prospective, non-randomized and multicenter study designed to compare biological features between pN0 triple negative breast cancer (TNBC) with size ≤ 10 mm (pT1a/b) versus pT1c T2 ≤ 30 mm. All consecutive patients will be recruited by each investigator after completion of surgery. No modification of standard management according to each investigator center will be done. All patients will then be followed each year during 5 years in order to collect the following events: local and loco regional recurrence, metastatasis, second cancer, death or not and the cause. At initial visit, a 10 mL blood sample will be collected (= study intervention) and immediately processed for serum storage; all serum samples will be stored at -80°C and may be used for the purpose of further scientific research. A representative formalin-fixed paraffin-embedded tumor block of all 200 samples will be addressed at the Institut Claudius Regaud for central collection which will consist of one haematoxylin-eosin stained slide for central histological review, up to 15 unstained slides for DNA extraction (after microdissection), and construction of a tissue micro-array (TMA). Extracted DNA from 100 samples (50 in each group) will then be transferred to Institut Paoli Calmettes, Marseille; extracted DNA will be subjected to array-CGH analysis in order to detect gene copy number alterations such as gains/amplifications/deletions, and to next generation sequencing (NGS; MiSeq, Illumina) using a panel of \~400 genes for mutation detection.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
151
Blood samples of 10 mL will be collected at initial visit; serum samples will then be stored at the end of the study (-80°C) and may be used for the purpose of further scientific research.
Institut de Cancerologie de L'Ouest - Site Paul Papin
Angers, France
Centre Francois Baclesse
Caen, France
Centre Jean Perrin
Clermont-Ferrand, France
CH Emile ROUX
Le Puy-en-Velay, France
CHU de LIMOGES - HOPITAL DUPUYTREN
Limoges, France
Institut Paoli Calmettes
Marseille, France
Institut Regional Du Cancer Montpellier
Montpellier, France
Clinique La Croix Du Sud
Quint-Fonsegrives, France
Institut de Cancerologie de L'Ouest - Site Rene Gauducheau
Saint-Herblain, France
Institut Claudius Regaud
Toulouse, France
...and 1 more locations
Biomarker signature for pT1a/b pN0 triple-negative breast cancers versus pN0 triple-negative breast cancers with size > or = 11 mm and < or = 30 mm.
biomarker signature will be defined from the protein expression of one or several biomarker(s).
Time frame: 3 years.
Disease free survival.
Disease Free Survival is defined as the time from inclusion until any recurrence (local or regional), contro-lateral breast cancer, second primary breast cancer, distant metastasis, or death from any cause.
Time frame: 7 years.
Metastasis Free Survival.
Metastasis Free Survival is defined as the time from inclusion until distant metastasis or last follow-up news (censored data). All other events are ignored for this endpoint.
Time frame: 7 years.
Overall survival.
Overall survival is defined as the time from inclusion until death from any cause or last follow-up news (censured data).
Time frame: 7 years.
Description and comparison of gene copy number (array-CGH) and gene mutation (targeted NGS) between pT1a/b pN0 triple-negative breast cancer versus pN0 triple-negative breast cancer with size ≥ 11 mm and ≤ 30 mm.
Time frame: 7 years.
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