Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
NCT ID:
NCT02311959
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Study:
NCT02311959
Study Brief:
Protocol Section:
NCT02311959