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Therapeutic Nipple Sparing Mastectomy.
Sponsor: Institut Claudius Regaud
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
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