Therapeutic Nipple Sparing Mastectomy. (MAPAM-01)

August 2, 2023 updated by: Institut Claudius Regaud

Therapeutic Nipple Areola Skin-sparing Mastectomy.

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

450

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Blois, France, 41000
        • Centre Hospitalier de Blois
      • Bordeaux, France, 33076
        • Institut Bergonie
      • Chambray-lès-Tours, France, 37170
        • Pole Sante Leonard de Vinci
      • Dijon, France, 21079
        • Centre Georges François Leclerc
      • Guilherand-Granges, France, 07500
        • Hôpital privé Drôme Ardèche
      • La Rochelle, France, 17000
        • Clinique du Mail
      • La Tronche, France, 38700
        • Centre Hospitalier Universitaire Grenoble Alpes
      • Lambres-lez-Douai, France, 59552
        • Clinique Saint Ame
      • Levallois-perret, France, 92300
        • Hopital de Levallois-Perret
      • Lille, France, 59000
        • Centre Oscar Lambret
      • Lyon, France, 69008
        • Centre Leon Berard
      • Lyon, France, 69317
        • Hôpital de La Croix Rousse
      • Marseille, France, 13273
        • Institut Paoli Calmettes
      • Montpellier, France, 34295
        • Centre Hospitalier Universitaire de Montpellier
      • Montpellier, France, 34298
        • Institut Du Cancer de Montpellier
      • Montpellier, France, 34070
        • Clinique Clementville
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Paris, France, 75015
        • Hôpital Européen Georges Pompidou, Assistance Publique - Hôpitaux de Paris
      • Paris, France, 75020
        • AP-HP - Hopital Tenon
      • Pierre Benite, France, 69495
        • CHRU Lyon Sud
      • Poitiers, France, 86 000
        • Centre Hospitalier de Poitiers
      • Rennes, France, 35042
        • Centre Eugène Marquis
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Rouen, France, 76175
        • Clinique Mathilde
      • Saint-Etienne, France, 42013
        • Clinique Mutualiste Chirurgicale
      • Saint-Grégoire, France, 35760
        • Etablissement Rennais du Sein - CHP St Grégoire
      • Saint-Herblain, France, 44805
        • Institut de Cancérologie de l'Ouest - Site René Gauducheau
      • Saint-cloud, France, 92210
        • Hôpital René Huguenin
      • Saint-Étienne, France, 42100
        • Hôpital privé de la Loire
      • Toulouse, France, 31059
        • Institut Claudius Regaud
      • Toulouse, France, 31077
        • Clinique Saint Jean
      • Vandoeuvre-Les-Nancy, France, 54519
        • Institut de Cancerologie de Lorraine
      • Villejuif, France, 94805
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Invasive or in situ breast carcinoma.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local recurrence rate.
Time Frame: 9 years.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early and late complications
Time Frame: 9 years.
Early and late complications will be evaluated using NCI toxicity scale version 4.0.
9 years.
Disease free Survival.
Time Frame: 9 years.

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.
Metastasis Free Survival.
Time Frame: 9 years.
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.
Overall Survival.
Time Frame: 9 years
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
Aesthetic evaluation.
Time Frame: 9 years.
The aesthetic evaluation will be realized by both the surgeon and the patient using to the Licket scale.
9 years.
Quality of life.
Time Frame: 9 years.
The quality of life will be evaluated according to the Breast-Q questionnaire.
9 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Claudius Regaud

Collaborators

Institut Paoli-Calmettes

Investigators

  • Principal Investigator: Eva JOUVE, Md., IUCT-O

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2015

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

December 5, 2014

First Submitted That Met QC Criteria

December 5, 2014

First Posted (Estimated)

December 9, 2014

Study Record Updates

Last Update Posted (Actual)

August 3, 2023

Last Update Submitted That Met QC Criteria

August 2, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 14 SEIN 10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Nipple sparing mastectomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe