NCT03900299

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
114

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started May 2017

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 3, 2019

Completed
10 months until next milestone

Results Posted

Study results publicly available

January 21, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

1 year

First QC Date

March 20, 2019

Results QC Date

September 20, 2019

Last Update Submit

July 15, 2020

Conditions

Breast Cancer

Keywords

breast conservative surgeryoncoplastic breast surgery

Outcome Measures

Primary Outcomes (1)

  • Recurrence of the Tumor

    assessment of the occurrence of local or distant recurrence through: 1. monthly clinical examination of both breast and axillae 2. monthly liver functions tests and complete blood count 3. radiological assessment if clinically indicated

    a median of 30 months post operative

Secondary Outcomes (1)

  • Cosmetic Result

    a median of 30 months post operative

Study Arms (1)

oncoplastic breast surgery

OTHER
Procedure: oncoplastic breast surgery

Interventions

oncoplastic breast surgeryPROCEDURE

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

oncoplastic breast surgery

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsall operable female patients affected with multifocal breast cancer
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • all operable female patients affected with multifocal breast cancer

You may not qualify if:

  • inflammatory breast cancer
  • patients need receiving neoadjuvant therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine ,Alexandria university

Alexandria, 21500, Egypt

Location

Related Publications (2)

  • 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.

    PMID: 19082705RESULT

  • 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.

    PMID: 18330695RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
DR. mostafa elsayed
Organization
Alexandria university
m_elsayed2009@yahoo.com
560566541

Study Officials

  • Ahmed T. Awad, MD

    professor of surgical oncology,Alexandria university

    STUDY DIRECTOR

  • Mostafa M. Elsayed, Msc

    Surgical oncology registrar,Alexandria university

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
registrar of surgical oncology and general surgery

Study Record Dates

First Submitted

March 20, 2019

First Posted

April 3, 2019

Study Start

May 1, 2017

Primary Completion

May 1, 2018

Study Completion

December 1, 2020

Last Updated

July 29, 2020

Results First Posted

January 21, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

IPD will be available that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
will be available for 1 year after publication
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
More information

Available IPD Datasets

Study Protocol Access

Locations

EG(1)