Clinical trial NCT05054777: Patient Report Outcome and Oncological Safety -Oncoplastic and Conventional BCS Cohort
Official title: Chinese Multicenter Prospective Registry of Breast Cancer Patient Reported Outcome and Oncological Safety -Oncoplastic and Conventional BCS Cohort
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patient Reported Outcome
Oncological Safety
Breast-conserving Surgery
Breast Cancer Female
Lead sponsor: Shandong Cancer Hospital and Institute
Sponsor class: OTHER
First posted: 2021-09-23
Enrollment: 5000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
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 the hospital. The patients must fulfill indications of breast cancer surgery according to NCCN clinical guidelines, and do not have any absolute contraindications.

Brief summary: Breast-conserving surgery (BCS) is the traditional surgical treatment for early-stage breast cancer patients. There are evidences indicating that oncoplastic BCS could improve cosmetic outcomes and/or quality of life, and has similar oncological safety as conventional BCS does. However, these studies that focused on patient-reported outcomes and oncological safety were mainly from one institution or of small sample size. The variations across hospitals and regions were not fully analyzed. A multicenter prospective patient report outcome (PROs) and oncological safety will be planned to assess the PROs and safety for Chinese breast cancer patients who will undergo oncoplastic and conventional breast-conserving surgery (OBCS). This study follows the Helsinki Declaration and Chinese rules. All patients will be asked to sign the informed consent and will be followed up 24 months after operations. All data will be collected.


Eligibility criteria: Inclusion Criteria:

1. Informed consent signed;
2. Non-metastatic Breast cancer patients confirmed by pathology;
3. Adult (\>18 years old, \<80 years old);
4. Female;
5. Must undergo oncoplastic or conventional breast-conserving surgery;

Exclusion Criteria:

1. Inflammatory breast cancer, Stage IV breast cancer patients;
2. Have other malignant tumors;
3. Pregnancy women;
4. Have severe co-morbidities that compromise the patients' compliance to our protocol, or endanger the patients;
5. Refuse breast-conserving surgery.

Primary outcomes:
measure: Patients' satisfaction：BREAST-Q score
timeFrame: Change from baseline at 6 months, 1 year and 2 years post-operatively
measure: EORTC QLQ-C30
timeFrame: Change from baseline at 1 year and 2 years post-operatively
measure: Health-related quality of life：EORTC QLQ-BR23
timeFrame: Change from baseline at 1 year and 2 years post-operatively
measure: Recurrence-free survival
timeFrame: up to 24 months
Secondary outcomes:
measure: Complication's ratio
timeFrame: up to 24 months
measure: Cosmetic results
timeFrame: Change from baseline at 1 year and 2 years post-operatively
measure: Overall survival
timeFrame: up to 24 months
Other outcomes:
Locations:
Study officials:
References:
citation: Weber WP, Soysal SD, Fulco I, Barandun M, Babst D, Kalbermatten D, Schaefer DJ, Oertli D, Kappos EA, Haug M. Standardization of oncoplastic breast conserving surgery. Eur J Surg Oncol. 2017 Jul;43(7):1236-1243. doi: 10.1016/j.ejso.2017.01.006. Epub 2017 Jan 31.