Prospective Non-randomized Evaluation of Oncoplastic Breast-conserving Surgery in Non-metastatic Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Harvard/NSABP/RTOG breast cosmesis grading scale
研究概览
简要总结
Breast-conserving surgery (BCS) is the traditional surgical treatment for early-stage breast cancer patients. There are evidences indicating that oncoplastic-BCS (displacement technique) could improve cosmetic outcomes and/or quality of life, and has similar oncological safety as traditional BCS does. However, there are no prospective trial comparing oncoplastic-BCS vs. traditional BCS in terms of cosmetic outcomes and oncological safety. In this study, the investigators are going to address this issue by assigning patients into traditional and oncoplastic-BCS group, based on their preference.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Informed consent signed
- •Non-metastatic breast cancer patients with unilateral breast cancer confirmed by pathology.
- •Operable or operable after neoadjuvant chemotherapy.
- •Extensive, diffuse micro-calcifications on mammography before surgery
- •No history of breast surgery or breast radiation therapy before.
- •Able to follow the standard of care in adjuvant chemotherapy, radiation therapy, endocrine therapy and targeted therapy after surgery.
排除标准
- •Multifocal/multicentric diseases noticed before surgery.
- •Inflammatory breast cancer or invasive micro-papillary carcinoma of the breast confirmed by pathology before surgery.
- •Tumor size > 5 cm revealed by physical examination, Ultrasound or mammography before surgery.
- •Tumor size/breast size ratio >0.5 revealed by by physical examination, Ultrasound or mammography before surgery.
- •Have other malignant tumors.
- •Have severe co-morbidities that compromise the patients' compliance to our protocol, or endanger the patients.
- •Participated in other clinical trials.
- •Pathologically confirmed metastatic breast cancer, bilateral breast cancer or DCIS patients.
- •Patients with any organ failure.
- •Pregnancy women
- •Patients who desire to have mastectomy before surgery.
研究组 & 干预措施
Traditional BCS
Breast-conserving surgery. Modified radical mastectomy.
干预措施: Breast surgery (Procedure)
Traditional BCS
Breast-conserving surgery. Modified radical mastectomy.
干预措施: Chemotherapy or endocrine therapy or Trastuzumab therapy (Drug)
Traditional BCS
Breast-conserving surgery. Modified radical mastectomy.
干预措施: Radiation therapy (Radiation)
Oncoplastic-BCS
Breast-conserving surgery. Modified radical mastectomy. Oncoplastic-BCS based on surgeon preference and/or tumor location.
- Superior pedicle mammoplasty / inverted T
- Superior pedicle mammoplasty / V scar
- Batwing
- Inferior pedicle mammoplasty
- Racquet mammoplasty/radial scar
- vertical-scar mammoplasty
干预措施: Breast surgery (Procedure)
Oncoplastic-BCS
Breast-conserving surgery. Modified radical mastectomy. Oncoplastic-BCS based on surgeon preference and/or tumor location.
- Superior pedicle mammoplasty / inverted T
- Superior pedicle mammoplasty / V scar
- Batwing
- Inferior pedicle mammoplasty
- Racquet mammoplasty/radial scar
- vertical-scar mammoplasty
干预措施: Chemotherapy or endocrine therapy or Trastuzumab therapy (Drug)
Oncoplastic-BCS
Breast-conserving surgery. Modified radical mastectomy. Oncoplastic-BCS based on surgeon preference and/or tumor location.
- Superior pedicle mammoplasty / inverted T
- Superior pedicle mammoplasty / V scar
- Batwing
- Inferior pedicle mammoplasty
- Racquet mammoplasty/radial scar
- vertical-scar mammoplasty
干预措施: Radiation therapy (Radiation)
结局指标
主要结局
Harvard/NSABP/RTOG breast cosmesis grading scale
时间窗: 5 years
次要结局
- Local-recurrence free survival(5 years)
- Disease free survival(5 years)
- Breast Cancer Treatment Outcome Scale (BCTOS)(5 years)
- Positivity rate of cavity margin(Intraoperatively.)
- Morbidity(1 year)
研究者
Erwei Song, M.D., Ph.D.
Professor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University