Safety of Breast-Conserving Surgery for Multifocal or Multicentric Breast Cancer
Starting soon
Conditions studied: Breast Cancer
In brief
The objective of this observational study is to evaluate the oncological safety of breast-conserving surgery combined with standard postoperative radiotherapy in adult female patients diagnosed with multifocal or multicentric breast cancer. The main questions it aims to answer are: What is the local recurrence rate and the time distribution of local recurrence after breast-conserving therapy in patients with multifocal or multicentric breast cancer? What independent risk factors are associated with postoperative local recurrence among these patients? There is no separate comparison group in this single-arm prospective cohort study. Participants will: Receive standardized breast-conserving surgery plus routine postoperative radiotherapy and individualized adjuvant therapy in accordance with clinical guidelines; Complete regular clinical follow-up visits, telephone and WeChat follow-ups for at least 3 years after surgery to collect data on surgical complications, tumor recurrence, metastasis and survival status; Fill out standardized questionnaires including Breast-Q, SDS, SAS and EORTC QLQ-C30 to assess postoperative breast satisfaction, psychological status and quality of life.
Key facts
- Study ID
- NCT07677956
- Run by
- The First Affiliated Hospital with Nanjing Medical University
- People needed
- 100
- Starts
- 2026-07-15
- Expected to finish
- 2036-12-30
- Last updated by the study team
- 2026-07-01
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Female patients aged ≥18 years with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Pathologically confirmed invasive breast carcinoma or ductal carcinoma in situ (DCIS);
- Radiologically confirmed unilateral multifocal or multicentric breast cancer;
- No systemic distant metastasis detected on preoperative imaging;
- Comprehensive clinical evaluation predicts all tumor lesions can be completely resected by breast-conserving surgery (BCS) to obtain negative surgical margins, and patients are suitable for standardized adjuvant whole-breast radiotherapy postoperatively;
- Adequate function of vital organs (cardiac, hepatic, renal and hematopoietic systems) to tolerate surgery, subsequent adjuvant radiotherapy and chemotherapy;
- Voluntarily agree to participate in the study after fully understanding the study purpose, procedures, potential risks and benefits, and provide written informed consent.
You may not qualify if…
- Inflammatory breast cancer;
- Extensive tumor burden that prevents complete resection via breast-conserving surgery or attainment of negative surgical margins;
- Severe dysfunction or failure of vital organs (heart, liver, kidney, lung) making patients unable to tolerate surgery, radiotherapy or chemotherapy;
- Pregnant or lactating women who are ineligible for postoperative radiotherapy;
- Patients who are unwilling or unable to complete long-term postoperative follow-up and data collection.
Full record on ClinicalTrials.gov
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