Local Recurrence of Malignant Tumor of Breast
Conditions
Keywords
Morbidity, The Breast Cancer Treatment Outcome Scale, Disease free survival, Positivity cavity margin rate, Harvard/NSABP/RTOG breast cosmesis grading scale
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.
Interventions
PROCEDUREBreast surgery
Traditional breast-conserving surgery, oncoplastic breast-conserving surgery or modified radical mastectomy
DRUGChemotherapy or endocrine therapy or Trastuzumab therapy
RADIATIONRadiation therapy
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Harvard/NSABP/RTOG breast cosmesis grading scale | 5 years |
Secondary
| Measure | 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 |
Outcome results
None listed