Therapeutic Nipple Areola Skin-sparing Mastectomy.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 54
- 主要终点
- Local recurrence rate.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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 =
- •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.
排除标准
- •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.
研究组 & 干预措施
Invasive or in situ breast carcinoma.
干预措施: Nipple sparing mastectomy (Procedure)
结局指标
主要结局
Local recurrence rate.
时间窗: 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..
次要结局
- Overall Survival.(9 years)
- Early and late complications(9 years.)
- Quality of life.(9 years.)
- Aesthetic evaluation.(9 years.)
- Disease free Survival.(9 years.)
- Metastasis Free Survival.(9 years.)