Breast Cancer
Conditions
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
Study design
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
Inclusion criteria
* all operable female patients affected with multifocal breast cancer
Exclusion criteria
* inflammatory breast cancer * patients need receiving neoadjuvant therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of the Tumor | a median of 30 months post operative | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cosmetic Result | a median of 30 months post operative | 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 |
Countries
Egypt
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 114 |
Baseline characteristics
| Characteristic | Multifocal Breast Cancer Patients Treated Surgically by MRM | Total | Multifocal Breast Cancer Patients Treated Surgically by OPS |
|---|---|---|---|
| Age, Customized <40 | 3 Participants | 8 Participants | 5 Participants |
| Age, Customized 40-49 | 10 Participants | 28 Participants | 18 Participants |
| Age, Customized 50-59 | 14 Participants | 28 Participants | 14 Participants |
| Age, Customized 60+ | 29 Participants | 50 Participants | 21 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Egypt | 56 participants | 114 participants | 58 participants |
| Sex: Female, Male Female | 56 Participants | 114 Participants | 58 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| tumor size T1 | 23 Participants | 57 Participants | 34 Participants |
| tumor size T2 | 32 Participants | 56 Participants | 24 Participants |
| tumor size T3 | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 0 / 58 |
| other Total, other adverse events | 0 / 56 | 0 / 58 |
| serious Total, serious adverse events | 29 / 56 | 28 / 58 |
Outcome results
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Multifocal Breast Cancer Patients Treated Surgically by MRM | Recurrence of the Tumor | Tumor recurrence | 2 Participants |
| Multifocal Breast Cancer Patients Treated Surgically by MRM | Recurrence of the Tumor | no tumor recurrence | 54 Participants |
| Multifocal Breast Cancer Patients Treated Surgically by OPS | Recurrence of the Tumor | Tumor recurrence | 3 Participants |
| Multifocal Breast Cancer Patients Treated Surgically by OPS | Recurrence of the Tumor | no tumor recurrence | 55 Participants |
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
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Multifocal Breast Cancer Patients Treated Surgically by MRM | Cosmetic Result | theraputic lateral mammoplasty | excellent cosmetic result | 13 Participants |
| Multifocal Breast Cancer Patients Treated Surgically by MRM | Cosmetic Result | theraputic lateral mammoplasty | very good cosmetic result | 7 Participants |
| Multifocal Breast Cancer Patients Treated Surgically by MRM | Cosmetic Result | round block | excellent cosmetic result | 13 Participants |
| Multifocal Breast Cancer Patients Treated Surgically by MRM | Cosmetic Result | round block | very good cosmetic result | 1 Participants |
| Multifocal Breast Cancer Patients Treated Surgically by MRM | Cosmetic Result | parallelogram mastopxy | excellent cosmetic result | 7 Participants |
| Multifocal Breast Cancer Patients Treated Surgically by MRM | Cosmetic Result | parallelogram mastopxy | very good cosmetic result | 2 Participants |
| Multifocal Breast Cancer Patients Treated Surgically by MRM | Cosmetic Result | V theraputic mammoplasty | excellent cosmetic result | 3 Participants |
| Multifocal Breast Cancer Patients Treated Surgically by MRM | Cosmetic Result | V theraputic mammoplasty | very good cosmetic result | 1 Participants |
| Multifocal Breast Cancer Patients Treated Surgically by MRM | Cosmetic Result | Latissimus Dorsi flap | excellent cosmetic result | 1 Participants |
| Multifocal Breast Cancer Patients Treated Surgically by MRM | Cosmetic Result | Latissimus Dorsi flap | very good cosmetic result | 2 Participants |
| Multifocal Breast Cancer Patients Treated Surgically by MRM | Cosmetic Result | J theraputic mammoplasty | excellent cosmetic result | 3 Participants |
| Multifocal Breast Cancer Patients Treated Surgically by MRM | Cosmetic Result | J theraputic mammoplasty | very good cosmetic result | 1 Participants |
| Multifocal Breast Cancer Patients Treated Surgically by MRM | Cosmetic Result | grisotti flap | excellent cosmetic result | 1 Participants |
| Multifocal Breast Cancer Patients Treated Surgically by MRM | Cosmetic Result | grisotti flap | very good cosmetic result | 1 Participants |
| Multifocal Breast Cancer Patients Treated Surgically by MRM | Cosmetic Result | reduction therapeutic mammoplasty | excellent cosmetic result | 1 Participants |
| Multifocal Breast Cancer Patients Treated Surgically by MRM | Cosmetic Result | reduction therapeutic mammoplasty | very good cosmetic result | 1 Participants |