Status:
COMPLETED
Therapeutic Nipple Sparing Mastectomy.
Lead Sponsor:
Institut Claudius Regaud
Collaborating Sponsors:
Institut Paoli-Calmettes
Conditions:
Breast Cancer
Eligibility:
FEMALE
40+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 9 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 4 2024
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT02311959
Start Date
February 9 2015
End Date
December 4 2024
Last Update
December 24 2024
Active Locations (33)
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1
Centre Hospitalier de Blois
Blois, France, 41000
2
Institut Bergonie
Bordeaux, France, 33076
3
Pôle santé Léonard de Vinci
Chambray-lès-Tours, France, 37170
4
Centre Georges Francois Leclerc
Dijon, France, 21079