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.
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;
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;
This single-center prospective cohort enrolls women aged ≥18 years with an ECOG performance status of 0-1 and pathologically confirmed unilateral multifocal/multicentric breast cancer without distant metastasis. Eligible candidates are suitable for breast-conserving surgery with negative margins and postoperative adjuvant radiotherapy. Patients with inflammatory breast cancer, extensive unresectable lesions, severe vital organ dysfunction, pregnancy or lactation, or poor follow-up compliance will be excluded. All participants provide written informed consent and receive standard routine treatment, with long-term follow-up conducted to observe oncological outcomes, surgical complications and patient-reported quality of life.
Cohort
Prospective
Breast-conserving surgery, postoperative radiotherapy and individualized adjuvant systemic therapy
Other interventionAll patients receive routine standard clinical treatment rather than investigational interventions, including breast-conserving surgery, axillary staging surgery, postoperative adjuvant radiotherapy, and guideline-concordant chemotherapy, endocrine therapy or anti-HER2 targeted therapy according to pathological and molecular characteristics.
Local recurrence rate of ipsilateral breast
Ipsilateral breast local recurrence rate within 3 years after breast-conserving surgery
Incidence of postoperative surgical complications
Incidence of short-term complications after surgery, short-term complications (hemorrhage, wound infection, skin flap necrosis) occurring within 30 days after surgery. Long-term upper extremity lymphedema will be monitored for up to 3 years.
Disease-free survival (DFS)
DFS is defined as the time interval from surgery to the first event of tumor recurrence, distant metastasis, or breast cancer-related death.
Overall survival (OS)
OS is defined as the time from surgery to all-cause death
Regional lymph node recurrence rate
Incidence of ipsilateral axillary regional lymph node recurrence during follow-up
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