Clinical trial NCT02311959: Therapeutic Nipple Sparing Mastectomy.
Official title: Therapeutic Nipple Areola Skin-sparing Mastectomy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Breast
Invasive carcinoma
In situ carcinoma
Mastectomy
Nipple areola
Reconstruction
Local recurrence
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
Collaborators: name: Institut Paoli-Calmettes
First posted: 2014-12-09
Enrollment: 450
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Patient with invasive breast carcinoma stage T1 or T2 and / or in situ (any histological type) proved on histopathological diagnosis.
* Patient with an indication of total mastectomy.
* Patient without preoperative indication of adjuvant radiotherapy according to regional and / or national guidelines.
* Disease located more than 2 cm from the nipple after complete clinical and radiologic breast evaluation (mammography, ultrasound +/- MRI).
* Initial breast cancer or recurrence.
* Patient wishing to receive immediate breast reconstruction.
* WHO performance \< or = 2.
* Patient older than 40 years.
* For patients of childbearing age, use an effective contraceptive methods for the duration of the study.
* For patients of childbearing potential, negative pregnancy test available before inclusion.
* Patient affiliated to a social health insurance in France.
* Patient who signed informed consent before enrollment in the study and before any specific procedure for the study.

Exclusion Criteria :

* Positive node on physical examination or proved by cytology.
* Combination of 2 predictive factors of postoperative radiotherapy : macroscopic multifocal, grade 2 or 3, vascular emboli, overexpressed HER2 (human epidermal growth factor receptor-2), triple negative (Estrogen Receptor, Progesterone Receptor and HER2 negative).
* Neoadjuvant treatment for the current disease.
* Patient with bilateral breast cancer.
* Paget disease.
* T3 or T4 carcinoma.
* Metastatic breast cancer (disease staging realized according to national or regional guidelines).
* Breast hypertrophy requiring a nipple support flap.
* Nursing or pregnant woman.
* Patient participating in any other interventional clinical study.
* Any psychological, familial, geographic or social situation not to comply with medical monitoring and/or procedures in the study protocol.
* Patient protected by law.

Primary outcomes:
measure: Local recurrence rate.
timeFrame: 9 years.
Secondary outcomes:
measure: Early and late complications
timeFrame: 9 years.
measure: Disease free Survival.
timeFrame: 9 years.
measure: Metastasis Free Survival.
timeFrame: 9 years.
measure: Overall Survival.
timeFrame: 9 years
measure: Aesthetic evaluation.
timeFrame: 9 years.
measure: Quality of life.
timeFrame: 9 years.
Other outcomes:
Locations:
city: Blois
country: France
facility: Centre Hospitalier de Blois
city: Bordeaux
country: France
facility: Institut Bergonie
city: Chambray-lès-Tours
country: France
facility: Pôle santé Léonard de Vinci
city: Dijon
country: France
facility: Centre Georges Francois Leclerc
city: Guilherand-Granges
country: France
facility: Hôpital privé Drôme Ardèche
city: La Rochelle
country: France
facility: Clinique du Mail
city: La Tronche
country: France
facility: Centre Hospitalier Universitaire Grenoble Alpes
city: Lambres-lez-Douai
country: France
facility: Clinique Saint Amé
city: Levallois-perret
country: France
facility: Hopital de Levallois-Perret
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Leon Berard
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Montpellier
country: France
facility: Clinique Clementville
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire de Montpellier
city: Montpellier
country: France
facility: Institut Du Cancer de Montpellier
city: Nice
country: France
facility: Centre Antoine LACASSAGNE
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou, Assistance Publique - Hôpitaux de Paris
city: Paris
country: France
facility: Ap-Hp - Hopital Tenon
city: Pierre Benite
country: France
facility: CHRU Lyon Sud
city: Poitiers
country: France
facility: Centre Hospitalier de Poitiers
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Rouen
country: France
facility: Clinique Mathilde
city: Saint-cloud
country: France
facility: Hôpital René Huguenin
city: Saint-Etienne
country: France
facility: Clinique Mutualiste Chirurgicale
city: Saint-Grégoire
country: France
facility: Etablissement Rennais du Sein - CHP St Grégoire
city: Saint-Herblain
country: France
facility: INSTITUT DE CANCEROLOGIE DE L'OUEST - Site René Gauducheau
city: Saint-Étienne
country: France
facility: Hôpital Privé de la Loire
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Toulouse
country: France
facility: Clinique Saint Jean
city: Vandoeuvre-Les-Nancy
country: France
facility: Institut de Cancerologie de Lorraine
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: IUCT-O
name: Eva JOUVE, Md.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Filleron T, Lusque A, Dalenc F, Ferron G, Roche H, Martinez A, Jouve E. Alternative methodological approach to randomized trial for surgical procedures routinely used. Contemp Clin Trials. 2018 May;68:109-115. doi: 10.1016/j.cct.2018.03.016. Epub 2018 Mar 30.