Skip to main content
OpenTrials
Completed

NCT Number: NCT02311959

Therapeutic Nipple 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Carcinoma Carcinoma in Situ Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Centre Hospitalier de Blois, Blois, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nipple sparing mastectomy

Procedure

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).

Primary outcomes

  1. 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..

Secondary outcomes

  1. Early and late complications

    Time frame: 9 years.

    Early and late complications will be evaluated using NCI toxicity scale version 4.0.

  2. 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.

  3. 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).

  4. 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).

  5. Aesthetic evaluation.

    Time frame: 9 years.

    The aesthetic evaluation will be realized by both the surgeon and the patient using to the Licket scale.

  6. Quality of life.

    Time frame: 9 years.

    The quality of life will be evaluated according to the Breast-Q questionnaire.

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Collaborators

  • Institut Paoli-Calmettes

Registry information

Official study title

Therapeutic Nipple Areola Skin-sparing Mastectomy.

Acronym: MAPAM-01

Important dates

Study start
2015
Primary completion
2024
Study completion
2024
First posted
Dec 9, 2014
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.