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

Withdrawn

• Conditions: Local Recurrence of Malignant Tumor of Breast
• Interventions: Procedure: Breast surgery; Drug: Chemotherapy or endocrine therapy or Trastuzumab therapy; Radiation: Radiation therapy

• Registration Number: NCT02376413
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-17
• Study First Submitted QC: 2015-02-24
• Study Start: 2015-03
• Study First Posted: 2015-03-03
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-02
• Last Update Posted: 2015-12-03
• Primary Completion: 2022-03
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Traditional BCS	Chemotherapy or endocrine therapy or Trastuzumab therapy	Breast-conserving surgery. Modified radical mastectomy.
Oncoplastic-BCS	Breast surgery	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
Traditional BCS	Radiation therapy	Breast-conserving surgery. Modified radical mastectomy.
Traditional BCS	Breast surgery	Breast-conserving surgery. Modified radical mastectomy.
Oncoplastic-BCS	Radiation therapy	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
Oncoplastic-BCS	Chemotherapy or endocrine therapy or Trastuzumab therapy	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

Primary Outcome Measures

Name	Time	Method
Harvard/NSABP/RTOG breast cosmesis grading scale	5 years

Secondary Outcome Measures

Name	Time	Method
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