Breast CancerPhase 3MAPAM-01NCT02311959
Therapeutic Nipple Sparing Mastectomy.
A Phase 3 study testing Nipple sparing mastectomy in people with Breast Cancer, run by Institut Claudius Regaud at 33 sites in France.
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… Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Nipple sparing mastectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 33 sitesFrance
- Study dates
- 9 Feb 2015to 4 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
France33 sites
Centre Hospitalier de Blois
Blois, 41000
Institut Bergonie
Bordeaux, 33076
Pôle santé Léonard de Vinci
Chambray-lès-Tours, 37170
Centre Georges Francois Leclerc
Dijon, 21079
Hôpital privé Drôme Ardèche
Guilherand-Granges, 07500
Clinique du Mail
La Rochelle, 17000
Centre Hospitalier Universitaire Grenoble Alpes
La Tronche, 38700
Clinique Saint Amé
Lambres-lez-Douai, 59552
Hopital de Levallois-Perret
Levallois-Perret, 92300
Centre Oscar Lambret
Lille, 59000
Centre Leon Berard
Lyon, 69008
Hôpital de la Croix Rousse
Lyon, 69317
Institut Paoli Calmettes
Marseille, 13273
Clinique Clementville
Montpellier, 34070
Centre Hospitalier Universitaire de Montpellier
Montpellier, 34295
Institut Du Cancer de Montpellier
Montpellier, 34298
Centre Antoine LACASSAGNE
Nice, 06189
Hôpital Européen Georges Pompidou, Assistance Publique - Hôpitaux de Paris
Paris, 75015
Ap-Hp - Hopital Tenon
Paris, 75020
CHRU Lyon Sud
Pierre-Bénite, 69495
Centre Hospitalier de Poitiers
Poitiers, 86 000
Centre Eugène Marquis
Rennes, 35042
Centre Henri Becquerel
Rouen, 76038
Clinique Mathilde
Rouen, 76175
Hôpital René Huguenin
Saint-Cloud, 92210
Clinique Mutualiste Chirurgicale
Saint-Etienne, 42013
Hôpital Privé de la Loire
Saint-Etienne, 42100
Etablissement Rennais du Sein - CHP St Grégoire
Saint-Grégoire, 35760
INSTITUT DE CANCEROLOGIE DE L'OUEST - Site René Gauducheau
Saint-Herblain, 44805
Institut Claudius Regaud
Toulouse, 31059
Clinique Saint Jean
Toulouse, 31077
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, 54519
Institut Gustave Roussy
Villejuif, 94805
About this study
Official title: 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.
Read more
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.
- Conditions
- Breast Cancer
- Being tested
- Nipple sparing mastectomy
- Keywords
- Breast, Invasive carcinoma, In situ carcinoma, Mastectomy, Nipple areola, Reconstruction, Local recurrence
- Medical subject headings
- Breast Neoplasms, Carcinoma in Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nipple sparing mastectomyProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Invasive or in situ breast carcinoma. | Experimental | Not described Receives: Procedure: Nipple sparing mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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..
Measured: 9 years.
Secondary outcomes (6)
Early and late complications
Early and late complications will be evaluated using NCI toxicity scale version 4.0.
Measured: 9 years.
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.
Measured: 9 years.
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).
Measured: 9 years.
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).
Measured: 9 years
Aesthetic evaluation.
The aesthetic evaluation will be realized by both the surgeon and the patient using to the Licket scale.
Measured: 9 years.
Quality of life.
The quality of life will be evaluated according to the Breast-Q questionnaire.
Measured: 9 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study start9 Feb 2015
- Primary completion4 Dec 2024
- Study completion4 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Paoli-Calmettes
- Responsible party
- Sponsor
- Investigators
- Eva JOUVE, Md., Principal investigator, IUCT-O
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02311959
- Sponsor's protocol ID
- 14 SEIN 10
- Acronym
- MAPAM-01
- Status last verified
- Apr 2026
- First submitted
- 5 Dec 2014
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29608972
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Nipple Areola Skin-sparing Mastectomy.
- ClinicalTrials.gov ID
- NCT02311959
- Acronym / sponsor ID
- MAPAM-01 / 14 SEIN 10
- Conditions
- Breast Cancer
- Keywords
- Breast, Invasive carcinoma, In situ carcinoma, Mastectomy, Nipple areola, Reconstruction, Local recurrence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Collaborators
- Institut Paoli-Calmettes
- Study start
- 9 Feb 2015 (actual)
- Primary completion
- 4 Dec 2024 (actual)
- Study completion
- 4 Dec 2024 (actual)
- First posted
- 9 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Invasive or in situ breast carcinoma. | Experimental | Procedure: Nipple sparing mastectomy |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nipple sparing mastectomyStandardized 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). | Procedure or surgery | Invasive or in situ breast carcinoma. |
Primary outcome
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..
6 secondary outcomes
Early and late complications
Time frame: 9 years.
Disease free Survival.
Time frame: 9 years.
Metastasis Free Survival.
Time frame: 9 years.
Overall Survival.
Time frame: 9 years
Aesthetic evaluation.
Time frame: 9 years.
Quality of life.
Time frame: 9 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Background: PubMed 29608972Filleron 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.
Related trials for Breast Cancer
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
Low-Dose Apatinib Plus Chemotherapy in ADC-Pretreated HER2-Positive and HER2-Low Advanced Breast Cancer
Breast Neoplasms, Advanced Breast Cancer
RecruitingPhase 3
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
Breast Neoplasms
Active, not recruitingPhase 2
Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases
Breast Cancer Stage IV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva JOUVE, Md. principal investigator
IUCT-O
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nipple sparing mastectomy in people with Breast Cancer, run by Institut Claudius Regaud at 33 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local recurrence rate. (time frame: 9 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02311959, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.