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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
450
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).
Centre Hospitalier de Blois
Blois, France
Institut Bergonie
Bordeaux, France
Pôle santé Léonard de Vinci
Chambray-lès-Tours, France
Centre Georges Francois Leclerc
Dijon, France
Hôpital privé Drôme Ardèche
Guilherand-Granges, France
Clinique du Mail
Local recurrence rate.
Annual incidence of local recurrence defined by the number of local recurrences (skin, thoracic wall and nipple) among the patient years of follow-up..
Time frame: 9 years.
Early and late complications
Early and late complications will be evaluated using NCI toxicity scale version 4.0.
Time frame: 9 years.
Disease free Survival.
Disease-free survival is the period between the date of origin and date of the first event as defined below, or date of latest news (Censored Data). The events included in the definition of disease-free survival are local recurrence, lymph node metastases, contralateral locations, distant metastases, second breast cancer and death from any causes.
Time frame: 9 years.
Metastasis Free Survival.
Metastasis free survival is defined as the time from inclusion until the date of metastasis recurrence or the date of the latest news (Censored data).
Time frame: 9 years.
Overall Survival.
Overall survival is defined as the time from inclusion until the date of death or the date of the latest news (Censored data).
Time frame: 9 years
Aesthetic evaluation.
The aesthetic evaluation will be realized by both the surgeon and the patient using to the Licket scale.
Time frame: 9 years.
Quality of life.
The quality of life will be evaluated according to the Breast-Q questionnaire.
Time frame: 9 years.
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La Rochelle, France
Centre Hospitalier Universitaire Grenoble Alpes
La Tronche, France
Clinique Saint Amé
Lambres-lez-Douai, France
Hopital de Levallois-Perret
Levallois-Perret, France
Centre Oscar Lambret
Lille, France
...and 23 more locations