NCT02266420

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: Institut Claudius Regaud · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Triple Negative Breast Cancers Without Lymph-node Involvement and < or = 30 mm

Interventions

Type	Name	Description
PROCEDURE	Blood samples of 10 mL	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.

Timeline

• Start date: 2014-10-23
• Primary completion: 2021-07-26
• Completion: 2024-10-29
• First posted: 2014-10-17
• Last updated: 2024-12-03

Locations

11 sites across 1 country: France