Oncological Safety of Oncoplastic Breast Surgery in Multicentric Breast Cancer

Active, not recruiting

• Conditions: Safety of Breast Coservative Multicenteric Breast Cancer; Breast Neoplasms; Breast Cancer; Multicentric

• Registration Number: NCT06926335
• Lead Sponsor: Assiut University

Brief Summary

The purpose of the study is to evaluate Oncological safety of oncoplastic breast surgery in multicentric breast cancer

Detailed Description

Breast cancer is the most prevalent cancer in women worldwide, accounting for about 23.8%. Multifocal and multicentric breast tumors are defined as two or more neoplasms separated in one breast. In multifocal tumors, a quarter of the breast is involved while in multicentric tumors, two quarters or more are involved. There is no exact radiological definition, but the distance between the multifocal tumors is less than or equal to 5 cm, whereas the distance between multicentric tumors is 5 cm, or more.

Due to increasingly use of more developed imaging methods such as tomosynthesis, magnetic resonance imaging (MRI) in these patients, we face more MF/MC breast cancer cases. It is seen that MF/MC breast cancer incidence ranges from 6% to 75% in different series.

Breast-conserving surgery (BCS) and radiotherapy have been adopted as the main treatment methods for early breast cancer. However, there are some studies stating that BCS carries risks for local recurrence in patients with MF/MC breast cancer.

Oncoplastic breast conservation (OBC) relies on applying plastic surgery principles within the context of sound oncological resection. Volume-reducing or volume- replacing methods are utilised to optimise postoperative appearances whilst prioritizing negative margin resection, supported by prompt adjuvant therapy. In fact, it is agreed that in cases where more than 20% of the breast tissue must be excised for oncological margin clearance, oncoplastic surgery is likely to require more complex techniques.This may allow larger specimens to be resected than in traditional breast conservation surgery, but with comparable histopathological properties to those who would be offered mastectomy.

Previous work has suggested that as such, OBC should be regarded as a separate entity from breast conservation therapy, and that direct comparison with mastectomy outcomes should be performed to inform decision-making amongst clinicians and with patients when planning for surgery.

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03-19
• Study First Submitted: 2025-04-01
• Study First Submitted QC: 2025-04-11
• Study First Posted: 2025-04-13
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-17
• Primary Completion: 2025-05-01
• Study Completion: 2026-04-19

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Female patients with multicentric breast cancer
• Female Patient aged from 18 to 65 years old
• Patients who are fit for general anesthesia.
• Patients who provide a written informed consent.
• Patient who agree to provide short term outcome data and agree to provide contact information to provide contact information

Exclusion Criteria

• Female patients less than 20 years old
• Stage 4 breast cancer
• Patients who are contraindicated for radiotherapy
• Pregnant patients in first trimester
• Patient with inflammatory carcinoma

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate Oncological safety of oncoplastic breast surgery in multicentric breast cancer	5 years	Number of multicentric breast cancer who underwent breast conservative surgery with no recurrance

Trial Locations

Locations (1)

Assuit University; 🇪🇬 Assuit, Egypt