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

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Non-randomized Evaluation of Oncoplastic Breast-conserving Surgery in Non-metastatic Breast Cancer Patients

Conditions
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Local Recurrence of Malignant Tumor of Breast

Intervention / Treatment
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* Procedure: Breast surgery
* Drug: Chemotherapy or endocrine therapy or Trastuzumab therapy
* Radiation: Radiation therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Traditional BCS<br>Breast-conserving surgery. Modified radical mastectomy. | Procedure: Breast surgery<br>* Traditional breast-conserving surgery, oncoplastic breast-conserving surgery or modified radical mastectomy<br>Drug: Chemotherapy or endocrine therapy or Trastuzumab therapy<br> <br> Radiation: Radiation therapy<br> <br> |
| Oncoplastic-BCS<br>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 | Procedure: Breast surgery<br>* Traditional breast-conserving surgery, oncoplastic breast-conserving surgery or modified radical mastectomy<br>Drug: Chemotherapy or endocrine therapy or Trastuzumab therapy<br> <br> Radiation: Radiation therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harvard/NSABP/RTOG breast cosmesis grading scale |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positivity rate of cavity margin |  | Intraoperatively. | 
| Local-recurrence free survival |  | 5 years | 
| Disease free survival |  | 5 years | 
| Breast Cancer Treatment Outcome Scale (BCTOS) |  | 5 years | 
| Morbidity |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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The Breast Cancer Treatment Outcome Scale, Disease free survival, Positivity cavity margin rate, Harvard/NSABP/RTOG breast cosmesis grading scale, Morbidity