Prospective Non-randomized Evaluation of Oncoplastic Breast-conserving Surgery in Non-metastatic Breast Cancer Patients
Overview
- Phase
- Not Applicable
- Intervention
- Breast surgery
- Conditions
- Local Recurrence of Malignant Tumor of Breast
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Primary Endpoint
- Harvard/NSABP/RTOG breast cosmesis grading scale
- Status
- Withdrawn
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Investigators
Erwei Song, M.D., Ph.D.
Professor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
Traditional BCS
Breast-conserving surgery. Modified radical mastectomy.
Intervention: Breast surgery
Traditional BCS
Breast-conserving surgery. Modified radical mastectomy.
Intervention: Chemotherapy or endocrine therapy or Trastuzumab therapy
Traditional BCS
Breast-conserving surgery. Modified radical mastectomy.
Intervention: Radiation therapy
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
Intervention: Breast surgery
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
Intervention: Chemotherapy or endocrine therapy or Trastuzumab therapy
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
Intervention: Radiation therapy
Outcomes
Primary Outcomes
Harvard/NSABP/RTOG breast cosmesis grading scale
Time Frame: 5 years
Secondary Outcomes
- 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)