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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
oncoplastic breast surgery
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast conservative surgery, oncoplastic breast surgery

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • all operable female patients affected with multifocal breast cancer

Exclusion Criteria:

  • inflammatory breast cancer
  • patients need receiving neoadjuvant therapy

Sites / Locations

  • Faculty of medicine ,Alexandria university

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

oncoplastic breast surgery

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 20, 2019
Last Updated
July 15, 2020
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT03900299
Brief Title
Evaluating New Surgical Technique in Management of Female Patients With Operable Multifocal Breast Cancer
Official Title
Tailoring Surgical Management of Multifocal Breast Cancer:is There a Possibility
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast conservative surgery, oncoplastic breast surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All operable(don't require neoadjuvant therapy or inflammatory carcinoma) female patients diagnosed as multifocal breast cancer will receive oncoplastic breast surgery as a surgical treatment.
Masking
None (Open Label)
Allocation
N/A
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
oncoplastic breast surgery
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
oncoplastic breast surgery
Intervention Description
oncoplastic breast surgery with level 1 or 2 according to the case using intra operative frozen section to assess the margin
Primary Outcome Measure Information:
Title
Recurrence of the Tumor
Description
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
Time Frame
a median of 30 months post operative
Secondary Outcome Measure Information:
Title
Cosmetic Result
Description
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
Time Frame
a median of 30 months post operative

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
all operable female patients affected with multifocal breast cancer
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: all operable female patients affected with multifocal breast cancer Exclusion Criteria: inflammatory breast cancer patients need receiving neoadjuvant therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed T. Awad, MD
Organizational Affiliation
professor of surgical oncology,Alexandria university
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mostafa M. Elsayed, Msc
Organizational Affiliation
Surgical oncology registrar,Alexandria university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of medicine ,Alexandria university
City
Alexandria
ZIP/Postal Code
21500
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD will be available that underlie results in a publication
IPD Sharing Time Frame
will be available for 1 year after publication
IPD Sharing Access Criteria
individual participant data will be available to every researcher in field of multi -focal breast cancer, the candidate should have an accepted protocol from the ethical committee of the organization. contacting the main investigator will be method to review the request
IPD Sharing URL
http://www.med.alexu.edu.eg/ethics-committee/
Citations:
PubMed Identifier
19082705
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):365-70. doi: 10.1007/s10549-008-0265-1. Epub 2008 Dec 11.
Results Reference
result
PubMed Identifier
18330695
Citation
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.
Results Reference
result

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

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