Trial Outcomes & Findings for Evaluating New Surgical Technique in Management of Female Patients With Operable Multifocal Breast Cancer (NCT NCT03900299)

Last Updated: 2020-07-29

Results Overview

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

Recruitment status

UNKNOWN

Study phase

Target enrollment

114 participants

Primary outcome timeframe

a median of 30 months post operative

Results posted on

2020-07-29

Participant Flow

Participant milestones

Participant milestones
Measure	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)	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)
Overall Study STARTED	56	58
Overall Study COMPLETED	56	58
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Multifocal Breast Cancer Patients Treated Surgically by MRM n=56 Participants 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)	Multifocal Breast Cancer Patients Treated Surgically by OPS n=58 Participants 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)	Total n=114 Participants Total of all reporting groups
Age, Customized <40	3 Participants n=56 Participants	5 Participants n=58 Participants	8 Participants n=114 Participants
Age, Customized 40-49	10 Participants n=56 Participants	18 Participants n=58 Participants	28 Participants n=114 Participants
Age, Customized 50-59	14 Participants n=56 Participants	14 Participants n=58 Participants	28 Participants n=114 Participants
Age, Customized 60+	29 Participants n=56 Participants	21 Participants n=58 Participants	50 Participants n=114 Participants
Sex: Female, Male Female	56 Participants n=56 Participants	58 Participants n=58 Participants	114 Participants n=114 Participants
Sex: Female, Male Male	0 Participants n=56 Participants	0 Participants n=58 Participants	0 Participants n=114 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Egypt	56 participants n=56 Participants	58 participants n=58 Participants	114 participants n=114 Participants
tumor size T1	23 Participants n=56 Participants	34 Participants n=58 Participants	57 Participants n=114 Participants
tumor size T2	32 Participants n=56 Participants	24 Participants n=58 Participants	56 Participants n=114 Participants
tumor size T3	1 Participants n=56 Participants	0 Participants n=58 Participants	1 Participants n=114 Participants

PRIMARY outcome

Timeframe: a median of 30 months post operative

Outcome measures

Outcome measures
Measure	Multifocal Breast Cancer Patients Treated Surgically by MRM n=56 Participants 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)	Multifocal Breast Cancer Patients Treated Surgically by OPS n=58 Participants 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)
Recurrence of the Tumor Tumor recurrence	2 Participants	3 Participants
Recurrence of the Tumor no tumor recurrence	54 Participants	55 Participants

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	Multifocal Breast Cancer Patients Treated Surgically by MRM n=58 Participants 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)	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)
Cosmetic Result theraputic lateral mammoplasty · excellent cosmetic result	13 Participants	—
Cosmetic Result theraputic lateral mammoplasty · very good cosmetic result	7 Participants	—
Cosmetic Result round block · excellent cosmetic result	13 Participants	—
Cosmetic Result round block · very good cosmetic result	1 Participants	—
Cosmetic Result parallelogram mastopxy · excellent cosmetic result	7 Participants	—
Cosmetic Result parallelogram mastopxy · very good cosmetic result	2 Participants	—
Cosmetic Result V theraputic mammoplasty · excellent cosmetic result	3 Participants	—
Cosmetic Result V theraputic mammoplasty · very good cosmetic result	1 Participants	—
Cosmetic Result Latissimus Dorsi flap · excellent cosmetic result	1 Participants	—
Cosmetic Result Latissimus Dorsi flap · very good cosmetic result	2 Participants	—
Cosmetic Result J theraputic mammoplasty · excellent cosmetic result	3 Participants	—
Cosmetic Result J theraputic mammoplasty · very good cosmetic result	1 Participants	—
Cosmetic Result grisotti flap · excellent cosmetic result	1 Participants	—
Cosmetic Result grisotti flap · very good cosmetic result	1 Participants	—
Cosmetic Result reduction therapeutic mammoplasty · excellent cosmetic result	1 Participants	—
Cosmetic Result reduction therapeutic mammoplasty · very good cosmetic result	1 Participants	—

Adverse Events

Multifocal Breast Cancer Patients Treated Surgically by MRM

Serious events: 29 serious events

Other events: 0 other events

Deaths: 0 deaths

Multifocal Breast Cancer Patients Treated Surgically by OPS

Serious events: 28 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Multifocal Breast Cancer Patients Treated Surgically by MRM n=56 participants at risk multifocal breast cancer patient treated by modified radical mastectomy(MRM) 66 patients Early complications Haematoma 2 patients out of 56 Seroma 16 patients out of 56 Skin or flap necrosis 5 patients out of 56 Abcess 3 patients out of 56 Late complications Scar fibrosis 2 patients out of 56 keloid 1 patients out of 56	Multifocal Breast Cancer Patients Treated Surgically by OPS n=58 participants at risk multifocal breast cancer patients treated by oncoplastic breast surgery(OPS) 58 patients Early complications Haematoma 2 patients out of 58 Seroma 10 patients out of 58 Abcess 4 patients out of 58 Skin or NAC necrosis 2 patients out of 58 Late complications Scar fibrosis 3 patients out of 58 keloid 2 patients out of 58 steatonecrosis 5 patients out of 58
Surgical and medical procedures Haematoma	3.6% 2/56 • Number of events 2 • through 24 months post operative Early complications 1. Haematoma 2. Seroma 3. Abcess 4. Skin or NAC necrosis Late complications 1. Scar fibrosis 2. keloid 3. steatonecrosis	3.4% 2/58 • Number of events 2 • through 24 months post operative Early complications 1. Haematoma 2. Seroma 3. Abcess 4. Skin or NAC necrosis Late complications 1. Scar fibrosis 2. keloid 3. steatonecrosis
Surgical and medical procedures Seroma	28.6% 16/56 • Number of events 16 • through 24 months post operative Early complications 1. Haematoma 2. Seroma 3. Abcess 4. Skin or NAC necrosis Late complications 1. Scar fibrosis 2. keloid 3. steatonecrosis	17.2% 10/58 • Number of events 10 • through 24 months post operative Early complications 1. Haematoma 2. Seroma 3. Abcess 4. Skin or NAC necrosis Late complications 1. Scar fibrosis 2. keloid 3. steatonecrosis
Surgical and medical procedures skin necrosis	8.9% 5/56 • Number of events 5 • through 24 months post operative Early complications 1. Haematoma 2. Seroma 3. Abcess 4. Skin or NAC necrosis Late complications 1. Scar fibrosis 2. keloid 3. steatonecrosis	3.4% 2/58 • Number of events 2 • through 24 months post operative Early complications 1. Haematoma 2. Seroma 3. Abcess 4. Skin or NAC necrosis Late complications 1. Scar fibrosis 2. keloid 3. steatonecrosis
Surgical and medical procedures abcess	5.4% 3/56 • Number of events 3 • through 24 months post operative Early complications 1. Haematoma 2. Seroma 3. Abcess 4. Skin or NAC necrosis Late complications 1. Scar fibrosis 2. keloid 3. steatonecrosis	6.9% 4/58 • Number of events 5 • through 24 months post operative Early complications 1. Haematoma 2. Seroma 3. Abcess 4. Skin or NAC necrosis Late complications 1. Scar fibrosis 2. keloid 3. steatonecrosis
Surgical and medical procedures Scar fibrosis	3.6% 2/56 • Number of events 2 • through 24 months post operative Early complications 1. Haematoma 2. Seroma 3. Abcess 4. Skin or NAC necrosis Late complications 1. Scar fibrosis 2. keloid 3. steatonecrosis	5.2% 3/58 • Number of events 3 • through 24 months post operative Early complications 1. Haematoma 2. Seroma 3. Abcess 4. Skin or NAC necrosis Late complications 1. Scar fibrosis 2. keloid 3. steatonecrosis
Surgical and medical procedures keloid	1.8% 1/56 • Number of events 1 • through 24 months post operative Early complications 1. Haematoma 2. Seroma 3. Abcess 4. Skin or NAC necrosis Late complications 1. Scar fibrosis 2. keloid 3. steatonecrosis	3.4% 2/58 • Number of events 2 • through 24 months post operative Early complications 1. Haematoma 2. Seroma 3. Abcess 4. Skin or NAC necrosis Late complications 1. Scar fibrosis 2. keloid 3. steatonecrosis
Surgical and medical procedures steatonecrosis	0.00% 0/56 • through 24 months post operative Early complications 1. Haematoma 2. Seroma 3. Abcess 4. Skin or NAC necrosis Late complications 1. Scar fibrosis 2. keloid 3. steatonecrosis	8.6% 5/58 • Number of events 5 • through 24 months post operative Early complications 1. Haematoma 2. Seroma 3. Abcess 4. Skin or NAC necrosis Late complications 1. Scar fibrosis 2. keloid 3. steatonecrosis

Other adverse events

Adverse event data not reported

Additional Information

DR. mostafa elsayed

Alexandria university

Phone: 560566541

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place