Clinical trial · Observational
Safety of Breast-Conserving Surgery for Multifocal or Multicentric Breast Cancer
Safety Evaluation of Breast-Conserving Surgery for Multifocal or Multicentric Breast Cancer: A Prospective Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast-conserving surgery, postoperative radiotherapy and individualized adjuvant systemic therapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Multifocal or Multicentric Breast Cancer Patients Undergoing Breast-Conserving Surgery
- description
- This cohort consists of female patients aged ≥18 years with pathologically confirmed unilateral multifocal or multicentric breast cancer who meet all inclusion and exclusion criteria. All participants receive standardized breast-conserving surgery combined with sentinel lymph node biopsy or axillary lymph node dissection as clinically indicated. Postoperatively, all subjects undergo standard adjuvant radiotherapy followed by individualized systemic adjuvant therapy (chemotherapy, endocrine therapy, anti-HER2 targeted therapy) formulated in accordance with national breast cancer clinical guidelines. No investigational interventions are administered, all treatments are routine standard clinical care. Participants will complete long-term follow-up for at least 3 years and finish validated patient-reported outcome (PRO) questionnaires at scheduled visits.
- interventionNames
- Other: Breast-conserving surgery, postoperative radiotherapy and individualized adjuvant systemic therapy
Primary outcomes (1)
- measure
- Local recurrence rate of ipsilateral breast
- timeFrame
- 3 years after surgery
- description
- Ipsilateral breast local recurrence rate within 3 years after breast-conserving surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female patients aged ≥18 years with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 2. Pathologically confirmed invasive breast carcinoma or ductal carcinoma in situ (DCIS); 3. Radiologically confirmed unilateral multifocal or multicentric breast cancer; 4. No systemic distant metastasis detected on preoperative imaging; 5. 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; 6. Adequate function of vital organs (cardiac, hepatic, renal and hematopoietic systems) to tolerate surgery, subsequent adjuvant radiotherapy and chemotherapy; 7. Voluntarily agree to participate in the study after fully understanding the study purpose, procedures, potential risks and benefits, and provide written informed consent. Exclusion Criteria: 1. Inflammatory breast cancer; 2. Extensive tumor burden that prevents complete resection via breast-conserving surgery or attainment of negative surgical margins; 3. Severe dysfunction or failure of vital organs (heart, liver, kidney, lung) making patients unable to tolerate surgery, radiotherapy or chemotherapy; 4. Pregnant or lactating women who are ineligible for postoperative radiotherapy; 5. Patients who are unwilling or unable to complete long-term postoperative follow-up and data collection.
References
Publications (8)
- BACKGROUNDPoenaru MO, Amza M, Toma CV, Augustin FE, Pacu I, Zampieri G, Ples L, Sima RM, Diaconescu AS. Multicentric and Multifocal Breast Tumors-Narrative Literature Review. Cancers (Basel). 2025 Oct 20;17(20):3380. doi: 10.3390/cancers17203380. PMID 41154435
- BACKGROUNDSun Y, Gao L, Zhou X, Wang Z, Li Y, Sun Q. Local Recurrence and Survival Outcomes of Multifocal/Multicentric Breast Cancer After Breast Conserving Therapy: A systematic Review and Meta-Analysis. Clin Breast Cancer. 2025 Apr;25(3):e229-e239.e9. doi: 10.1016/j.clbc.2024.10.009. Epub 2024 Oct 18. PMID 39542811
- BACKGROUNDMasannat YA, Rocco N, Garreffa E, Gulluoglu BM, Kothari A, Maglia A, Nava MB, Omar OS, Potter S, Catanuto G. Global variations in the definition and management of multifocal and multicentric breast cancer: the MINIM international survey. Br J Surg. 2022 Jul 15;109(8):656-659. doi: 10.1093/bjs/znac080. No abstract available. PMID 35352093
- BACKGROUNDDe Lorenzi F, Borelli F, Pagan E, Bagnardi V, Peradze N, Jereczek-Fossa BA, Leonardi C, Mazzarol G, Favia G, Corso G, Montagna E, Rietjens M, Veronesi P. Oncoplastic Breast-Conserving Surgery for Synchronous Multicentric and Multifocal Tumors: Is It Oncologically Safe? A Retrospective Matched-Cohort Analysis. Ann Surg Oncol. 2022 Jan;29(1):427-436. doi: 10.1245/s10434-021-10800-w. Epub 2021 Oct 6. PMID 34613536
- BACKGROUNDKoppiker C, Joshi S, Mishra R, Kelkar DA, Chigurupati P, Joshi A, John J, Kadu S, Bagdia A, Thakkar D, Deshmukh C, Allampati H, Sharan G, Dhar U, Nare S, Nagarkar S, Busheri L, Varghese B, Pai M. Therapeutic mammoplasty: a "wise" oncoplastic choice-lessons from the largest single-center cohort from Asia. Front Oncol. 2023 Apr 14;13:1131951. doi: 10.3389/fonc.2023.1131951. eCollection 2023. PMID 37124516
- BACKGROUNDZhang J, Fang H, Zhao Z, Guo Y, Li Y, Wang Y, Guo X, Ning Z, Wang H. Clinicopathological characteristics and prognostic analysis of multifocal/multicentric breast cancer. Sci Rep. 2025 Dec 29;15(1):44869. doi: 10.1038/s41598-025-28687-y.