Status:
COMPLETED
Comparison of Biological Features Between pN0 Triple Negative Breast Tumours With Size < or = 10 mm (pT1a/b) Versus pT1c T2 < or = 30 mm
Lead Sponsor:
Institut Claudius Regaud
Conditions:
Triple Negative Breast Cancers Without Lymph-node Involvement and < or = 30 mm
Eligibility:
FEMALE
18+ years
Phase:
NA
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. ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Non-invasive breast carcinoma (i.e. ductal carcinoma in situ exclusively).
- Inoperable breast invasive carcinoma.
- Synchronous bilateral breast cancer.
- Patients who received neo-adjuvant treatment (radiotherapy or chemotherapy or other before surgery).
- 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.
Key Trial Info
Start Date :
October 23 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 29 2024
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT02266420
Start Date
October 23 2014
End Date
October 29 2024
Last Update
December 3 2024
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Institut de Cancerologie de L'Ouest - Site Paul Papin
Angers, France, 49933
2
Centre Francois Baclesse
Caen, France, 14076
3
Centre Jean Perrin
Clermont-Ferrand, France, 63011
4
CH Emile ROUX
Le Puy-en-Velay, France, 43000