Therapeutic Nipple Sparing Mastectomy.

Breast Cancer Clinical Trial

— MAPAM-01  

Official title:

Therapeutic Nipple Areola Skin-sparing Mastectomy.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02311959
• Other study ID #: 14 SEIN 10
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: February 9, 2015
• Est. completion date: February 2025

Study information

• Verified date: August 2023
• Source: Institut Claudius Regaud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 450
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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

Country	Name	City	State
France	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	Centre Hospitalier Universitaire de Montpellier	Montpellier
France	Clinique Clementville	Montpellier
France	Institut Du Cancer de Montpellier	Montpellier
France	Centre Antoine LACASSAGNE	Nice
France	Ap-Hp - Hopital Tenon	Paris
France	Hôpital Européen Georges Pompidou, Assistance Publique - Hôpitaux de Paris	Paris
France	CHRU Lyon Sud	Pierre Benite
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-Étienne
France	Etablissement Rennais du Sein - CHP St Grégoire	Saint-Grégoire
France	INSTITUT DE CANCEROLOGIE DE L'OUEST - Site René Gauducheau	Saint-Herblain
France	Clinique Saint Jean	Toulouse
France	Institut Claudius Regaud	Toulouse
France	Institut de Cancerologie de Lorraine	Vandoeuvre-Les-Nancy
France	Institut Gustave Roussy	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
Institut Claudius Regaud	Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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..	9 years.
Secondary	Early and late complications	Early and late complications will be evaluated using NCI toxicity scale version 4.0.	9 years.
Secondary	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.	9 years.
Secondary	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).	9 years.
Secondary	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).	9 years
Secondary	Aesthetic evaluation.	The aesthetic evaluation will be realized by both the surgeon and the patient using to the Licket scale.	9 years.
Secondary	Quality of life.	The quality of life will be evaluated according to the Breast-Q questionnaire.	9 years.