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Nipple-Sparing mastectomy shows promise in breast cancer trial

NCT ID NCT02311959

Disease control Sponsor: Institut Claudius Regaud Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a type of breast cancer surgery called nipple-sparing mastectomy, where the breast tissue is removed but the nipple and skin are kept. It involved 450 women with early-stage breast cancer who needed a full mastectomy. The goal was to see if this surgery keeps the cancer from coming back in the same area while improving appearance and quality of life.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

450 people

The number who actually took part.

Started

Feb 2015

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast carcinoma in situ breast neoplasm in situ carcinoma invasive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • Ap-Hp - Hopital Tenon

    Paris, 75020, France

  • CHRU Lyon Sud

    Pierre-Bénite, 69495, France

  • Centre Antoine LACASSAGNE

    Nice, 06189, France

  • Centre Eugène Marquis

    Rennes, 35042, France

  • Centre Georges Francois Leclerc

    Dijon, 21079, France

  • Centre Henri Becquerel

    Rouen, 76038, France

  • Centre Hospitalier Universitaire Grenoble Alpes

    La Tronche, 38700, France

  • Centre Hospitalier Universitaire de Montpellier

    Montpellier, 34295, France

  • Centre Hospitalier de Blois

    Blois, 41000, France

  • Centre Hospitalier de Poitiers

    Poitiers, 86 000, France

  • Centre Leon Berard

    Lyon, 69008, France

  • Centre Oscar Lambret

    Lille, 59000, France

  • Clinique Clementville

    Montpellier, 34070, France

  • Clinique Mathilde

    Rouen, 76175, France

  • Clinique Mutualiste Chirurgicale

    Saint-Etienne, 42013, France

  • Clinique Saint Amé

    Lambres-lez-Douai, 59552, France

  • Clinique Saint Jean

    Toulouse, 31077, France

  • Clinique du Mail

    La Rochelle, 17000, France

  • Etablissement Rennais du Sein - CHP St Grégoire

    Saint-Grégoire, 35760, France

  • Hopital de Levallois-Perret

    Levallois-Perret, 92300, France

  • Hôpital Européen Georges Pompidou, Assistance Publique - Hôpitaux de Paris

    Paris, 75015, France

  • Hôpital Privé de la Loire

    Saint-Etienne, 42100, France

  • Hôpital René Huguenin

    Saint-Cloud, 92210, France

  • Hôpital de la Croix Rousse

    Lyon, 69317, France

  • Hôpital privé Drôme Ardèche

    Guilherand-Granges, 07500, France

  • INSTITUT DE CANCEROLOGIE DE L'OUEST - Site René Gauducheau

    Saint-Herblain, 44805, France

  • Institut Bergonie

    Bordeaux, 33076, France

  • Institut Claudius Regaud

    Toulouse, 31059, France

  • Institut Du Cancer de Montpellier

    Montpellier, 34298, France

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Institut Paoli Calmettes

    Marseille, 13273, France

  • Institut de Cancerologie de Lorraine

    Vandœuvre-lès-Nancy, 54519, France

  • Pôle santé Léonard de Vinci

    Chambray-lès-Tours, 37170, France

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