Therapeutic Nipple Sparing Mastectomy.
MAPAM-01
Therapeutic Nipple Areola Skin-sparing Mastectomy.
1 other identifier
interventional
450
1 country
33
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 breast-cancer
Started Feb 2015
Longer than P75 for phase_3 breast-cancer
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2014
CompletedFirst Posted
Study publicly available on registry
December 9, 2014
CompletedStudy Start
First participant enrolled
February 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 4, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 4, 2024
CompletedApril 14, 2026
April 1, 2026
9.8 years
December 5, 2014
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Early and late complications
9 years.
Disease free Survival.
9 years.
Metastasis Free Survival.
9 years.
Overall Survival.
9 years
Aesthetic evaluation.
9 years.
- +1 more secondary outcomes
Study Arms (1)
Invasive or in situ breast carcinoma.
EXPERIMENTALInterventions
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).
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut Claudius Regaudlead
- Institut Paoli-Calmettescollaborator
Study Sites (33)
Centre Hospitalier de Blois
Blois, 41000, France
Institut Bergonie
Bordeaux, 33076, France
Pôle santé Léonard de Vinci
Chambray-lès-Tours, 37170, France
Centre Georges Francois Leclerc
Dijon, 21079, France
Hôpital privé Drôme Ardèche
Guilherand-Granges, 07500, France
Clinique du Mail
La Rochelle, 17000, France
Centre Hospitalier Universitaire Grenoble Alpes
La Tronche, 38700, France
Clinique Saint Amé
Lambres-lez-Douai, 59552, France
Hopital de Levallois-Perret
Levallois-Perret, 92300, France
Centre Oscar Lambret
Lille, 59000, France
Centre Leon Berard
Lyon, 69008, France
Hôpital de la Croix Rousse
Lyon, 69317, France
Institut Paoli Calmettes
Marseille, 13273, France
Clinique Clementville
Montpellier, 34070, France
Centre Hospitalier Universitaire de Montpellier
Montpellier, 34295, France
Institut Du Cancer de Montpellier
Montpellier, 34298, France
Centre Antoine LACASSAGNE
Nice, 06189, France
Hôpital Européen Georges Pompidou, Assistance Publique - Hôpitaux de Paris
Paris, 75015, France
Ap-Hp - Hopital Tenon
Paris, 75020, France
CHRU Lyon Sud
Pierre-Bénite, 69495, France
Centre Hospitalier de Poitiers
Poitiers, 86 000, France
Centre Eugène Marquis
Rennes, 35042, France
Centre Henri Becquerel
Rouen, 76038, France
Clinique Mathilde
Rouen, 76175, France
Hôpital René Huguenin
Saint-Cloud, 92210, France
Clinique Mutualiste Chirurgicale
Saint-Etienne, 42013, France
Hôpital Privé de la Loire
Saint-Etienne, 42100, France
Etablissement Rennais du Sein - CHP St Grégoire
Saint-Grégoire, 35760, France
INSTITUT DE CANCEROLOGIE DE L'OUEST - Site René Gauducheau
Saint-Herblain, 44805, France
Institut Claudius Regaud
Toulouse, 31059, France
Clinique Saint Jean
Toulouse, 31077, France
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, 54519, France
Institut Gustave Roussy
Villejuif, 94805, France
Related Publications (1)
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.
PMID: 29608972BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eva JOUVE, Md.
IUCT-O
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2014
First Posted
December 9, 2014
Study Start
February 9, 2015
Primary Completion
December 4, 2024
Study Completion
December 4, 2024
Last Updated
April 14, 2026
Record last verified: 2026-04