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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03900299
Enrollment
114
Registered
2019-04-03
Start date
2017-05-01
Completion date
2020-12-31
Last updated
2020-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast conservative surgery, oncoplastic breast surgery

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.

Interventions

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

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

* all operable female patients affected with multifocal breast cancer

Exclusion criteria

* inflammatory breast cancer * patients need receiving neoadjuvant therapy

Design outcomes

Primary

MeasureTime frameDescription
Recurrence of the Tumora median of 30 months post operativeassessment 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

Secondary

MeasureTime frameDescription
Cosmetic Resulta median of 30 months post operativeassessment 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

Countries

Egypt

Participant flow

Participants by arm

ArmCount
Multifocal Breast Cancer Patients Treated Surgically by MRM
multifocal breast cancer patients involved in the study will be randomized to be treated either by oncoplastic breast conserving surgery or modified radical mastectomy(MRM)
56
Multifocal Breast Cancer Patients Treated Surgically by OPS
multifocal breast cancer patients involved in the study randomized in the setting of receiving surgical treatment either modified radical mastectomy (MRM) or oncoplastic breast surgery(OPS)
58
Total114

Baseline characteristics

CharacteristicMultifocal Breast Cancer Patients Treated Surgically by MRMTotalMultifocal Breast Cancer Patients Treated Surgically by OPS
Age, Customized
<40
3 Participants8 Participants5 Participants
Age, Customized
40-49
10 Participants28 Participants18 Participants
Age, Customized
50-59
14 Participants28 Participants14 Participants
Age, Customized
60+
29 Participants50 Participants21 Participants
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
Egypt
56 participants114 participants58 participants
Sex: Female, Male
Female
56 Participants114 Participants58 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants
tumor size
T1
23 Participants57 Participants34 Participants
tumor size
T2
32 Participants56 Participants24 Participants
tumor size
T3
1 Participants1 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 560 / 58
other
Total, other adverse events
0 / 560 / 58
serious
Total, serious adverse events
29 / 5628 / 58

Outcome results

Primary

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

Time frame: a median of 30 months post operative

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Multifocal Breast Cancer Patients Treated Surgically by MRMRecurrence of the TumorTumor recurrence2 Participants
Multifocal Breast Cancer Patients Treated Surgically by MRMRecurrence of the Tumorno tumor recurrence54 Participants
Multifocal Breast Cancer Patients Treated Surgically by OPSRecurrence of the TumorTumor recurrence3 Participants
Multifocal Breast Cancer Patients Treated Surgically by OPSRecurrence of the Tumorno tumor recurrence55 Participants
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

Time frame: a median of 30 months post operative

Population: overall number of participants subjected to oncoplastic breast surgery is 58 subdivided to categories according to the oncoplastic technique used, totally 58 patients

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Multifocal Breast Cancer Patients Treated Surgically by MRMCosmetic Resulttheraputic lateral mammoplastyexcellent cosmetic result13 Participants
Multifocal Breast Cancer Patients Treated Surgically by MRMCosmetic Resulttheraputic lateral mammoplastyvery good cosmetic result7 Participants
Multifocal Breast Cancer Patients Treated Surgically by MRMCosmetic Resultround blockexcellent cosmetic result13 Participants
Multifocal Breast Cancer Patients Treated Surgically by MRMCosmetic Resultround blockvery good cosmetic result1 Participants
Multifocal Breast Cancer Patients Treated Surgically by MRMCosmetic Resultparallelogram mastopxyexcellent cosmetic result7 Participants
Multifocal Breast Cancer Patients Treated Surgically by MRMCosmetic Resultparallelogram mastopxyvery good cosmetic result2 Participants
Multifocal Breast Cancer Patients Treated Surgically by MRMCosmetic ResultV theraputic mammoplastyexcellent cosmetic result3 Participants
Multifocal Breast Cancer Patients Treated Surgically by MRMCosmetic ResultV theraputic mammoplastyvery good cosmetic result1 Participants
Multifocal Breast Cancer Patients Treated Surgically by MRMCosmetic ResultLatissimus Dorsi flapexcellent cosmetic result1 Participants
Multifocal Breast Cancer Patients Treated Surgically by MRMCosmetic ResultLatissimus Dorsi flapvery good cosmetic result2 Participants
Multifocal Breast Cancer Patients Treated Surgically by MRMCosmetic ResultJ theraputic mammoplastyexcellent cosmetic result3 Participants
Multifocal Breast Cancer Patients Treated Surgically by MRMCosmetic ResultJ theraputic mammoplastyvery good cosmetic result1 Participants
Multifocal Breast Cancer Patients Treated Surgically by MRMCosmetic Resultgrisotti flapexcellent cosmetic result1 Participants
Multifocal Breast Cancer Patients Treated Surgically by MRMCosmetic Resultgrisotti flapvery good cosmetic result1 Participants
Multifocal Breast Cancer Patients Treated Surgically by MRMCosmetic Resultreduction therapeutic mammoplastyexcellent cosmetic result1 Participants
Multifocal Breast Cancer Patients Treated Surgically by MRMCosmetic Resultreduction therapeutic mammoplastyvery good cosmetic result1 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026