NCT02311959

Therapeutic Nipple Sparing Mastectomy.

Therapeutic Nipple Areola Skin-sparing Mastectomy.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (actual)
• Sponsor: Institut Claudius Regaud · Academic / Other
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This is a phase III, multicentric, single arm study with a sequential design using the exact conditional Poisson test. The primary objective of this prospective study is to evaluate whether selected breast carcinoma patients could be treated with nipple sparing mastectomy (NSM) with an acceptable low local recurrence rates. 450 patients will be included over a period of 4 years and will be followed for a 5 years period (twice a year). All patients must have a complete preoperative evaluation (bilateral mammography, bilateral breast ultrasonography +/- MRI), and a histopathological diagnostic proof of carcinoma (invasive or in situ, all histopathological types, first treatment or relapse). The study procedure is represented by nipple areola skin-sparing mastectomy followed by immediate breast reconstruction. After surgery, early and late complications, including specific complications (suffering of the nipple-areolar complexe and suffering of the skin flaps), will be evaluate. An esthetic evaluation (by patient and clinician) and a quality of life evaluation will be realized throughout the study. A complementary study, prospective, non-interventional, will be proposed to patients who will benefit from the same surgical technique (NSM) followed by immediate reconstruction, but in the context of preventive surgery (prophylactic surgery for patients mutated or high genetic risk). The aim of this complementary study, which will include a maximum of 60 patients, is to evaluate associated morbidity in prophylactic NSM. Data will be collected over a 3 months period after surgery.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Nipple sparing mastectomy	Standardized surgical procedure by : * Nipple sparing mastectomy with nipple core histopathology. * Immediate breast reconstruction (flap and/or implant). * +/- lymph node evaluation (sentinel node procedure or axillary dissection).

Timeline

• Start date: 2015-02-09
• Primary completion: 2024-12-04
• Completion: 2024-12-04
• First posted: 2014-12-09
• Last updated: 2026-04-14

Locations

33 sites across 1 country: France