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

Breast Cancer Clinical Trial

Official title:

Tailoring Surgical Management of Multifocal Breast Cancer:is There a Possibility

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03900299
• Other study ID #: multifocal breast cancer2018
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: December 2020

Study information

• Verified date: July 2020
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 114
• Est. completion date: December 2020
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• all operable female patients affected with multifocal breast cancer

Exclusion Criteria:

• inflammatory breast cancer

• patients need receiving neoadjuvant therapy

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of medicine ,Alexandria university	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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/multicentri — View Citation

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) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of the Tumor	assessment of the occurrence of local or distant recurrence through: monthly clinical examination of both breast and axillae; monthly liver functions tests and complete blood count; radiological assessment if clinically indicated	a median of 30 months post operative
Secondary	Cosmetic Result	assessment of breast cosmesis after oncoplastic surgical intervention.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.; each criteria will be evaluated either satisfactory or not,satisfactory evaluation will represent 1 point.; unsatisfactory will represent 0 point excellent result is equal or more than 4 points good result is equal to 3 points fair result is equal to 2 points bad result is equal to 1 point or less	a median of 30 months post operative