Evaluating New Surgical Technique in Management of Female Patients With Operable Multifocal Breast Cancer

NCT ID: NCT03900299

Last Updated: 2020-07-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2020-12-31

Brief Summary

Multi-focal Breast Cancers(MFBC) still have undiscoverable Clinical Significance reflecting on a debatable surgical decision for this Category of breast cancer. A prospective study was conducted using certain surgical technique as a surgical treatment for female patients with operable breast cancer managed at the Surgical Oncology Unit, Alexandria University from May. 2017 to May2018 and will be followed for 3 Years.Analysis will be done to settle a paradigm for surgical management of Multi-focal Breast Cancer

Detailed Description

• Age at diagnosis: young patients are defined as younger than 35 years.
• Surgical techniques: Preoperatively all patients will undergo physical examination of both breasts and axillae as well as bilateral mammograms and ultrasonography of both breasts. Histopathological diagnosis of cancer will be made prior to surgery. The planned procedure will be discussed. Different oncoplastic techniques will be utilized to achieve oncologically appropriate margins with either sentinel lymph node detection or axillary lymph node dissection according to the triple assessment of the patients . Surgical margins were determined by macroscopic and histologic examination of frozen sections of the breast specimens in the operating room. An adequate safety margin of 1cm was always insured. Breast remodeling will be done according to breast size, degree of ptosis and size of defect.
• Tumor characteristics: size, nodal status, presence of lympho-vascular invasion, amount of intraductal component, tumor grade, margin status, hormone receptor, and Her2 neu status.
• Margins will be regarded as negative when permanent histological examination found no ink on the tumor.
• Postoperative surgical complications will be documented if happened; seroma formation, hematoma and or wound dehiscence.
• Cosmetic outcome: The postoperative esthetic result will be evaluated asking the patients to rate the postoperative cosmetic result and their degree of satisfaction compared to the preoperative breast using a five-point scale (excellent, 5; good, 4; fair, 3; poor, 2;bad, 1). Objective assessment of the cosmetic result was done by two surgeons, rated on a visual analog scale from 1 (unacceptable result) to 10 (excellent result). Evaluation is based on 5 criteria, namely: breast symmetry, glandular tissue defects, nipple and areola reconstruction, scar quality and/or retraction, and the resultant breast shape. (14)
• The occurrence of loco-regional recurrence or distant metastases during the follow-up period was recorded and considered as an end point for follow-up.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

oncoplastic breast surgery

Group Type: OTHER

oncoplastic breast surgery

Intervention Type: PROCEDURE

oncoplastic breast surgery with level 1 or 2 according to the case using intra operative frozen section to assess the margin

Interventions

oncoplastic breast surgery

oncoplastic breast surgery with level 1 or 2 according to the case using intra operative frozen section to assess the margin

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• all operable female patients affected with multifocal breast cancer

Exclusion Criteria

• inflammatory breast cancer
• patients need receiving neoadjuvant therapy

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

mostafa mohamed elsayed

registrar of surgical oncology and general surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed T. Awad, MD

Role: STUDY_DIRECTOR

professor of surgical oncology,Alexandria university

Mostafa M. Elsayed, Msc

Role: PRINCIPAL_INVESTIGATOR

Surgical oncology registrar,Alexandria university

Locations

Faculty of medicine ,Alexandria university

Alexandria, , Egypt

Countries

Egypt

References

Yerushalmi R, Kennecke H, Woods R, Olivotto IA, Speers C, Gelmon KA. Does multicentric/multifocal breast cancer differ from unifocal breast cancer? An analysis of survival and contralateral breast cancer incidence. Breast Cancer Res Treat. 2009 Sep;117(2):365-70. doi: 10.1007/s10549-008-0265-1. Epub 2008 Dec 11.

Reference Type: RESULT

PMID: 19082705 (View on PubMed)

Gentilini O, Botteri E, Rotmensz N, Da Lima L, Caliskan M, Garcia-Etienne CA, Sosnovskikh I, Intra M, Mazzarol G, Musmeci S, Veronesi P, Galimberti V, Luini A, Viale G, Goldhirsch A, Veronesi U. Conservative surgery in patients with multifocal/multicentric breast cancer. Breast Cancer Res Treat. 2009 Feb;113(3):577-83. doi: 10.1007/s10549-008-9959-7. Epub 2008 Mar 11.

Reference Type: RESULT

PMID: 18330695 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Study Documents

Document Type: Study Protocol

View Document

Other Identifiers

multifocal breast cancer2018

Identifier Type: -

Identifier Source: org_study_id