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

Sun Yat-sen University

Status: Withdrawn

Conditions: Local Recurrence of Malignant Tumor of Breast

Treatments: Drug: Chemotherapy or endocrine therapy or Trastuzumab therapy; Radiation: Radiation therapy; Procedure: Breast surgery

Study type: Observational

Funder types: Other

Identifiers

NCT02376413

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Details and patient eligibility

About

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.

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

0 participants in 2 patient groups

Traditional BCS

Description:

Breast-conserving surgery. Modified radical mastectomy.

Treatment:

Drug: Chemotherapy or endocrine therapy or Trastuzumab therapy

Procedure: Breast surgery

Radiation: Radiation therapy

Oncoplastic-BCS

Description:

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

Treatment:

Drug: Chemotherapy or endocrine therapy or Trastuzumab therapy

Procedure: Breast surgery

Radiation: Radiation therapy