Oncoplastic Breast-conserving Surgery in Non-metastatic Breast Cancer Patients

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Overview

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.

Study Type

OBSERVATIONAL

Conditions

Local Recurrence of Malignant Tumor of Breast

Interventions

Breast surgeryPROCEDURE

Traditional breast-conserving surgery, oncoplastic breast-conserving surgery or modified radical mastectomy

Chemotherapy or endocrine therapy or Trastuzumab therapyDRUG

Radiation therapyRADIATION

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Informed consent signed * ECOG\<=2 * 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 * Patients who desire to have mastectomy before surgery.

Outcomes

Primary Outcomes

Harvard/NSABP/RTOG breast cosmesis grading scale

Time frame: 5 years

Secondary Outcomes

Positivity rate of cavity margin

Time frame: Intraoperatively.

Local-recurrence free survival

Time frame: 5 years

Disease free survival

Time frame: 5 years

Breast Cancer Treatment Outcome Scale (BCTOS)

Time frame: 5 years

Morbidity

Time frame: 1 year

Data from ClinicalTrials.gov

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