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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TNBC pT1a/b with size < or = 10 mm | Other | Patients with pN0 triple negative breast tumor with size < or = 10 mm (pT1a/b) Study intervention = blood samples collected at initial visit |
|
| TNBC pT1c T2 with size <or = 30 mm | Other | Patients with pN0 triple negative breast tumor with size < or = 30 mm (pT1c T2) Study intervention = blood samples collected at initial visit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood samples of 10 mL | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3 years. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 years. |
| Metastasis Free Survival. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Florence DALENC, Md. | Institut Claudius Regaud | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cancerologie de L'Ouest - Site Paul Papin | Angers | 49933 | France | |||
| Centre Francois Baclesse |
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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. |
| 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). | 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. | 7 years. |
| Caen |
| 14076 |
| France |
| Centre Jean Perrin | Clermont-Ferrand | 63011 | France |
| CH Emile ROUX | Le Puy-en-Velay | 43000 | France |
| CHU de LIMOGES - HOPITAL DUPUYTREN | Limoges | 87042 | France |
| Institut Paoli Calmettes | Marseille | 13273 | France |
| Institut Regional Du Cancer Montpellier | Montpellier | 34298 | France |
| Clinique La Croix Du Sud | Quint-Fonsegrives | 31130 | France |
| Institut de Cancerologie de L'Ouest - Site Rene Gauducheau | Saint-Herblain | 44805 | France |
| Institut Claudius Regaud | Toulouse | 31059 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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