Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
450 participants
INTERVENTIONAL
2015-02-09
2024-12-04
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Invasive or in situ breast carcinoma.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
FEMALE
No
Sponsors
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Institut Paoli-Calmettes
OTHER
Institut Claudius Regaud
OTHER
Responsible Party
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Principal Investigators
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Eva JOUVE, Md.
Role: PRINCIPAL_INVESTIGATOR
IUCT-O
Locations
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Centre Hospitalier de Blois
Blois, , France
Institut Bergonie
Bordeaux, , France
Pôle santé Léonard de Vinci
Chambray-lès-Tours, , France
Centre Georges Francois Leclerc
Dijon, , France
Hôpital privé Drôme Ardèche
Guilherand-Granges, , France
Clinique du Mail
La Rochelle, , France
Centre Hospitalier Universitaire Grenoble Alpes
La Tronche, , France
Clinique Saint Amé
Lambres-lez-Douai, , France
Hopital de Levallois-Perret
Levallois-Perret, , France
Centre Oscar Lambret
Lille, , France
Centre Leon Berard
Lyon, , France
Hôpital de la Croix Rousse
Lyon, , France
Institut Paoli Calmettes
Marseille, , France
Clinique Clementville
Montpellier, , France
Centre Hospitalier Universitaire de Montpellier
Montpellier, , France
Institut Du Cancer de Montpellier
Montpellier, , France
Centre Antoine LACASSAGNE
Nice, , France
Hôpital Européen Georges Pompidou, Assistance Publique - Hôpitaux de Paris
Paris, , France
Ap-Hp - Hopital Tenon
Paris, , France
CHRU Lyon Sud
Pierre-Bénite, , France
Centre Hospitalier de Poitiers
Poitiers, , France
Centre Eugène Marquis
Rennes, , France
Centre Henri Becquerel
Rouen, , France
Clinique Mathilde
Rouen, , France
Hôpital René Huguenin
Saint-Cloud, , France
Clinique Mutualiste Chirurgicale
Saint-Etienne, , France
Hôpital Privé de la Loire
Saint-Etienne, , France
Etablissement Rennais du Sein - CHP St Grégoire
Saint-Grégoire, , France
INSTITUT DE CANCEROLOGIE DE L'OUEST - Site René Gauducheau
Saint-Herblain, , France
Institut Claudius Regaud
Toulouse, , France
Clinique Saint Jean
Toulouse, , France
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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References
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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.
Other Identifiers
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14 SEIN 10
Identifier Type: -
Identifier Source: org_study_id