Safety of Breast-Conserving Surgery for Multifocal or Multicentric Breast Cancer

ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Breast-conserving surgery, postoperative radiotherapy and individualized adjuvant systemic therapy

Treatment groups

100 Participants
are divided into 1 treatment group

Locations

This trial has no locations