Clinical trial NCT02266420: Comparison of Biological Features Between pN0 Triple Negative Breast Tumours With Size < or = 10 mm (pT1a/b) Versus pT1c T2 < or = 30 mm
Official title: Comparison of Biological Features Between pN0 Triple Negative Breast Tumours With Size < or = 10 mm (pT1a/b) Versus pT1c T2 < or = 30 mm.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Triple Negative Breast Cancers Without Lymph-node Involvement and < or = 30 mm
Keywords: Triple negative breast cancer
immuno-histochemistery
genomic profiles
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2014-10-17
Enrollment: 151
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Woman with age ≥ 18 years.
2. Patient who completed surgery for his breast cancer and for which definitive histo-pathological analysis of surgical specimen is available.
3. Invasive breast carcinoma pN0 or pN(i+) with histological tumor size ≤ 10 mm (pT1a/b subgroup) or invasive breast carcinoma with histological tumor size \> 10 mm and ≤ 30 mm (pT1c T2 ≤ 30 mm control group).
4. Patient with HER2-negative breast carcinoma: immuno-histochemistry (IHC) score = 0, 1+ or 2+ and in situ hybridization (FISH, CISH, or SISH) negative (local laboratory testing).
5. Patient with ER and PR negative invasive carcinoma (\< 1% stained cells by immuno-histochemistry assay) (local laboratory testing).
6. In case of multifocality, the histological size of the largest tumor must be ≤ 10 mm or ≤ 30 mm according to the inclusion subgroup. All lesions must be ER, PR and HER2-negative.
7. In case of breast conserving surgery, clear margins are required.
8. Patient affiliated to a Social Health Insurance in France.
9. Patient information and written informed consent form signed prior to any study specific procedures.

Exclusion Criteria:

1. Patients with any previous malignancy of the breast or other site, with the exception of adequately treated basal or squamous cell carcinoma, non-melanomatous skin cancer totally resected.
2. Non-invasive breast carcinoma (i.e. ductal carcinoma in situ exclusively).
3. Inoperable breast invasive carcinoma.
4. Synchronous bilateral breast cancer.
5. Patients who received neo-adjuvant treatment (radiotherapy or chemotherapy or other before surgery).
6. Pregnant or breast-feeding women.
7. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.
8. Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.

Primary outcomes:
measure: 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.
timeFrame: 3 years.
Secondary outcomes:
measure: Disease free survival.
timeFrame: 7 years.
measure: Metastasis Free Survival.
timeFrame: 7 years.
measure: Overall survival.
timeFrame: 7 years.
measure: 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.
timeFrame: 7 years.
Other outcomes:
Locations:
city: Angers
country: France
facility: Institut de Cancerologie de L'Ouest - Site Paul Papin
city: Caen
country: France
facility: Centre Francois Baclesse
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Le Puy-en-Velay
country: France
facility: CH Emile ROUX
city: Limoges
country: France
facility: CHU de LIMOGES - HOPITAL DUPUYTREN
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Montpellier
country: France
facility: Institut Regional Du Cancer Montpellier
city: Quint-Fonsegrives
country: France
facility: Clinique La Croix Du Sud
city: Saint-Herblain
country: France
facility: Institut de Cancerologie de L'Ouest - Site Rene Gauducheau
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Institut Claudius Regaud
name: Florence DALENC, Md.
role: STUDY_CHAIR
References: