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COMPLETED
NCT02311959
PHASE3

Therapeutic Nipple Sparing Mastectomy.

Sponsor: Institut Claudius Regaud

View on ClinicalTrials.gov

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.

Official title: Therapeutic Nipple Areola Skin-sparing Mastectomy.

Key Details

Gender

FEMALE

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

450

Start Date

2015-02-09

Completion Date

2024-12-04

Last Updated

2026-04-14

Healthy Volunteers

No

Conditions

Interventions

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).

Locations (33)

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

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

Centre Leon Berard

Lyon, France

Hôpital de la Croix Rousse

Lyon, France

Institut Paoli Calmettes

Marseille, France

Clinique Clementville

Montpellier, France

Centre Hospitalier Universitaire de Montpellier

Montpellier, France

Institut Du Cancer de Montpellier

Montpellier, France

Centre Antoine LACASSAGNE

Nice, France

Hôpital Européen Georges Pompidou, Assistance Publique - Hôpitaux de Paris

Paris, France

Ap-Hp - Hopital Tenon

Paris, France

CHRU Lyon Sud

Pierre-Bénite, France

Centre Hospitalier de Poitiers

Poitiers, France

Centre Eugène Marquis

Rennes, France

Centre Henri Becquerel

Rouen, France

Clinique Mathilde

Rouen, France

Hôpital René Huguenin

Saint-Cloud, France

Clinique Mutualiste Chirurgicale

Saint-Etienne, France

Hôpital Privé de la Loire

Saint-Etienne, France

Etablissement Rennais du Sein - CHP St Grégoire

Saint-Grégoire, France

INSTITUT DE CANCEROLOGIE DE L'OUEST - Site René Gauducheau

Saint-Herblain, France

Institut Claudius Regaud

Toulouse, France

Clinique Saint Jean

Toulouse, France

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, France

Institut Gustave Roussy

Villejuif, France