Prospective, Multicentric Study Evaluating the Surgical Treatment by Mastectomy With Immediate Prosthetic Breast Reconstruction in Patients With Breast Cancer and Receiving Adjuvant Therapy by TomoTherapy +/-Chemotherapy.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 3
- 主要终点
- Rate of patients with successful mastectomy strategy by immediate reconstruction.
研究概览
简要总结
Prospective, multicentric, non-randomized phase II study evaluating the surgical treatment by mastectomy with immediate prosthetic breast reconstruction in patients with breast cancer and receiving adjuvant therapy by TomoTherapy +/-Chemotherapy.
Patients with non-inflammatory and non-metastatic invasive mammary carcinoma will be included in this study.
The study procedure will be a surgical treatment by mastectomy with immediate prosthetic breast reconstruction followed by an adjuvant therapy: TomoTherapy +/-Chemotherapy (radiation therapy alone or preceded by chemotherapy).
The nature of the chemotherapy treatment will be decided according to the standards of each center.
The patients will be followed for the study up to 36 months after the surgical procedure.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Patient with a non-inflammatory and non-metastatic invasive mammary carcinoma.
- •Indication of mastectomy and immediate prosthetic breast reconstruction.
- •Patient wishing to have an immediate mammary reconstruction with prosthesis.
- •Formal or presumptive pre-operative indication for adjuvant radiotherapy (+/- chemotherapy).
- •Patient affiliated to a Social Health Insurance in France.
- •Patient must provide written informed consent prior to any study specific procedures.
排除标准
- •Metastatic breast cancer.
- •Bilateral breast cancer.
- •Inflammatory breast cancer (T4d).
- •History of breast cancer within 5 years.
- •Not applicable according to the protocol version N°6 : Previous neoadjuvant treatment for the ongoing disease.
- •Pregnant or breastfeeding women.
- •Any psychological, familial, geographical or sociological condition which does not allow to respect the medical follow-up and/or compliance to study procedure.
- •Patient protected by law.
结局指标
主要结局
Rate of patients with successful mastectomy strategy by immediate reconstruction.
时间窗: 12 months for each patient
次要结局
- Quality of the radiotherapy treatment plan (dosimetry).(78 months for all patients)
- Progression-free survival.(36 months for each patient)
- Early complications assessed using the National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) version 4.03.(36 months for each patient)
- Quality of Life assessed using the questionnaire called "Breast-Q".(36 months for each patient)
- Late complications assessed using the National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) version 4.03.(36 months for each patient)
- Cosmetic outcome of treated breast assessed using a questionnaire with a Likert scale.(36 months for each patient)