Clinical trial NCT03900299: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: breast conservative surgery
oncoplastic breast surgery
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2019-04-03
Enrollment: 114
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* all operable female patients affected with multifocal breast cancer

Exclusion Criteria:

* inflammatory breast cancer
* patients need receiving neoadjuvant therapy

Primary outcomes:
measure: Recurrence of the Tumor
timeFrame: a median of 30 months post operative
Secondary outcomes:
measure: Cosmetic Result
timeFrame: a median of 30 months post operative
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of medicine ,Alexandria university
Study officials:
affiliation: professor of surgical oncology,Alexandria university
name: Ahmed T. Awad, MD
role: STUDY_DIRECTOR
affiliation: Surgical oncology registrar,Alexandria university
name: Mostafa M. Elsayed, Msc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.