Prospective Non-randomized Evaluation of Oncoplastic Breast-conserving Surgery in Non-metastatic Breast Cancer Patients
| Registry | NCT02376413 |
|---|---|
| Status | Withdrawn - Unavailable to recruit patients. |
| Study type | Observational |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other) |
| Conditions | Local Recurrence of Malignant Tumor of Breast |
| Interventions | Breast surgery, Chemotherapy or endocrine therapy or Trastuzumab therapy, Radiation therapy (Procedure, drug, radiation) |
| Dates | start 2015-03-01, primary completion 2022-03-01 (estimated), completion 2022-12-01 (estimated), first posted 2015-03-03, last updated 2015-12-03 |
Related Papers Related Patents Related Grants Related Experts
All trials for Local Recurrence of Malignant Tumor of Breast All trials of Breast surgery All trials of Chemotherapy or endocrine therapy or Trastuzumab therapy
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Traditional BCS | Procedure: Breast surgery; Drug: Chemotherapy or endocrine therapy or Trastuzumab therapy; Radiation: Radiation therapy | Breast-conserving surgery. Modified radical mastectomy. | |
| Oncoplastic-BCS | Procedure: Breast surgery; Drug: Chemotherapy or endocrine therapy or Trastuzumab therapy; Radiation: 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 |
Sex: Female, ages: 18 Years to 65 Years
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.