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

NCT07677956 | Not Yet Recruiting

• 1 other identifier: NJMU-BC14
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Breast Cancer

Keywords

Multifocal or multicentric breast cancer; Breast-conserving surgery; Local recurrence

Outcome Measures

Primary Outcomes (1)

• Local recurrence rate of ipsilateral breast

  Ipsilateral breast local recurrence rate within 3 years after breast-conserving surgery

  3 years after surgery

Secondary Outcomes (10)

• Incidence of postoperative surgical complications

  Within 3 years after surgery

• Disease-free survival (DFS)

  3 years after surgery

• Overall survival (OS)

  At least 3 years after surgery

• Regional lymph node recurrence rate

  3 years after surgery

• Contralateral breast malignancy rate

  3 years after surgery

Study Arms (1)

Multifocal or Multicentric Breast Cancer Patients Undergoing Breast-Conserving Surgery

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.

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

Interventions

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

All 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.

Multifocal or Multicentric Breast Cancer Patients Undergoing Breast-Conserving Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Related Publications (8)

• Poenaru 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 BACKGROUND

• Sun 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 BACKGROUND

• Masannat 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 BACKGROUND

• De 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 BACKGROUND

• Koppiker 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 BACKGROUND

• Zhang 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.

  PMID: 41462542 BACKGROUND

• Tong Y, Sun F, Zhang C, Yang S, Yu Z, Zhao Y. Multifocal/multicentric breast cancer: Does each focus matter? Cancer Med. 2023 Apr;12(7):8815-8824. doi: 10.1002/cam4.5626. Epub 2023 Feb 3.

  PMID: 36734288 BACKGROUND

• Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17-48. doi: 10.3322/caac.21763.

  PMID: 36633525 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mastectomy, Segmental

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative

Central Study Contacts

WenBin Zhou, Ph.D

CONTACT

025-68308161; Zhouwenbin@njmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: July 1, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): December 30, 2031
• Study Completion (Estimated): December 30, 2036
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share