Clinical trial NCT02376413: Oncoplastic Breast-conserving Surgery in Non-metastatic Breast Cancer Patients
Official title: Prospective Non-randomized Evaluation of Oncoplastic Breast-conserving Surgery in Non-metastatic Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Local Recurrence of Malignant Tumor of Breast
Keywords: Morbidity
The Breast Cancer Treatment Outcome Scale
Disease free survival
Positivity cavity margin rate
Harvard/NSABP/RTOG breast cosmesis grading scale
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2015-03-03
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-metastatic breast cancer patients received surgical treatment in Sun Yat-sen Memorial Hospital, Sun Yat-sen University. Informed consent must be obtained for all of the included patients.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Harvard/NSABP/RTOG breast cosmesis grading scale
timeFrame: 5 years
Secondary outcomes:
measure: Positivity rate of cavity margin
timeFrame: Intraoperatively.
measure: Local-recurrence free survival
timeFrame: 5 years
measure: Disease free survival
timeFrame: 5 years
measure: Breast Cancer Treatment Outcome Scale (BCTOS)
timeFrame: 5 years
measure: Morbidity
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Erwei Song, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Yat-sen Memorial Hospital, Sun Yat-sen University.
name: Fengxi Su, M.D.
role: STUDY_DIRECTOR
References: