NCT02266420Completed
Comparison of Biological Features Between pN0 Triple Negative Breast Tumours With Size < or = 10 mm (pT1a/b) Versus pT1c T2 < or = 30 mm
Comparison of Biological Features Between pN0 Triple Negative Breast Tumours With Size < or = 10 mm (pT1a/b) Versus pT1c T2 < or = 30 mm.
Source: ClinicalTrials.gov · Last updated 3 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 151 (actual)
- First submitted
- 13 Oct 2014
- Start date
- 23 Oct 2014
- Primary completion date
- 26 Jul 2021
- Lead sponsor
- Institut Claudius Regaud
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT02266420
What you commit to
- Study type: Interventional
- Participants enrolled: 151
- From 23 Oct 2014 to the primary completion date, 26 Jul 2021
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who received neo-adjuvant treatment (radiotherapy or chemotherapy or other before surgery).
Other illness
- 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.
- Synchronous bilateral breast cancer.
Other
- Non-invasive breast carcinoma (i.e. ductal carcinoma in situ exclusively).
- Inoperable breast invasive carcinoma.
- Pregnant or breast-feeding women.
- 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.
- Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.
Who the study is looking for
- Woman with age ≥ 18 years.
- Patient who completed surgery for his breast cancer and for which definitive histo-pathological analysis of surgical specimen is available.
- 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).
- 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).
- Patient with ER and PR negative invasive carcinoma (\< 1% stained cells by immuno-histochemistry assay) (local laboratory testing).
- 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.
- In case of breast conserving surgery, clear margins are required.
- Patient affiliated to a Social Health Insurance in France.
- Patient information and written informed consent form signed prior to any study specific procedures.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut de Cancérologie de l'Ouest - Site Paul Papin Coordinator of this site? Confirm its status | Angers | France | Unknown status |
| Centre François Baclesse Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| Centre Jean Perrin Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| CH Emile Roux Coordinator of this site? Confirm its status | Le Puy-en-Velay | France | Unknown status |
| CHU de Limoges-Hopital Dupuytren Coordinator of this site? Confirm its status | Limoges | France | Unknown status |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Institut Régional du Cancer Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| Clinique La Croix Du Sud Coordinator of this site? Confirm its status | Quint-Fonsegrives | France | Unknown status |
| Institut de Cancérologie de l'Ouest site René Gauducheau Coordinator of this site? Confirm its status | Saint-Herblain | France | Unknown status |
| Institut Claudius Regaud Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.