Breast CancerNCT03900299

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

A study testing oncoplastic breast surgery in people with Breast Cancer, run by Alexandria University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Any age, women only
Conditions the study is for: Breast Cancer
What is being tested?: oncoplastic breast surgery
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 114 participants
Where: 1 siteEgypt
Study dates: 1 May 2017to Dec 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
Women only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

all operable female patients affected with multifocal breast cancer

Who cannot join

inflammatory breast cancer
patients need receiving neoadjuvant therapy

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Faculty of medicine ,Alexandria university
Alexandria, 21500

Other trials in Egypt

About this study

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

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

Read the 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.

Conditions: Breast Cancer
Being tested: oncoplastic breast surgery
Keywords: breast conservative surgery, oncoplastic breast surgery
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03900299
Study group	Role	What they receive
oncoplastic breast surgery	Other	Not described Receives: Procedure: oncoplastic breast surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: a median of 30 months post operative

Secondary outcomes (1)

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
Measured: a median of 30 months post operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 2017Dec 2020

First posted3 Apr 2019
Study start1 May 2017
Primary completion1 May 2018
Study completionDec 2020 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by Alexandria UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
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.
Masking: None (open label)
Enrolment: 114 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03900299
Sponsor's protocol ID: multifocal breast cancer2018
Status last verified: Jul 2020
First submitted: 20 Mar 2019
Last updated: 29 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: IPD will be available that underlie results in a publication

Publications

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.
PubMed 19082705
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.
PubMed 18330695

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Tailoring Surgical Management of Multifocal Breast Cancer:is There a Possibility
ClinicalTrials.gov ID: NCT03900299
Acronym / sponsor ID: multifocal breast cancer2018
Conditions: Breast Cancer
Keywords: breast conservative surgery, oncoplastic breast surgery
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 114 participants (actual)
Lead sponsor: Alexandria UniversityUniversity, hospital or other
Study start: 1 May 2017 (actual)
Primary completion: 1 May 2018 (actual)
Study completion: Dec 2020 (estimated)
First posted: 3 Apr 2019 (actual)
Results: Posted 21 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
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.

Arm	Type	Receives
oncoplastic breast surgery	Other	Procedure: oncoplastic breast surgery

Who may qualify

Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

all operable female patients affected with multifocal breast cancer

Key exclusion criteria (2 listed)

inflammatory breast cancer
patients need receiving neoadjuvant therapy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
oncoplastic breast surgeryoncoplastic breast surgery with level 1 or 2 according to the case using intra operative frozen section to assess the margin	Procedure or surgery	oncoplastic breast surgery

Primary outcome

Recurrence of the Tumor
Time frame: 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

1 secondary outcome

Cosmetic Result
Time frame: a median of 30 months post operative

Results and safety

Results posted to the registry on 21 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Multifocal Breast Cancer Patients Treated Surgically by MRM	56	56
Multifocal Breast Cancer Patients Treated Surgically by OPS	58	58

Primary outcome: Recurrence of the Tumor

Time frame: a median of 30 months post operative. Count of participants. Unit: Participants

Measure	Multifocal Breast Cancer Patients Treated Surgically by MRM n = 56	Multifocal Breast Cancer Patients Treated Surgically by OPS n = 58
Tumor recurrence	2	3
no tumor recurrence	54	55

1 secondary outcome is reported in the full results.

Adverse events

Time frame: through 24 months post operative. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Multifocal Breast Cancer Patients Treated Surgically by MRM	29 of 56 (51.8%)	0 of 56 (0%)	0 of 56
Multifocal Breast Cancer Patients Treated Surgically by OPS	28 of 58 (48.3%)	0 of 58 (0%)	0 of 58

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19082705Yerushalmi 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.
Results publication: PubMed 18330695Gentilini 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.
Individual participant dataSharing planned: Yes. IPD will be available that underlie results in a publication

Related trials for Breast Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ahmed T. Awad, MD study director

professor of surgical oncology,Alexandria university

Mostafa M. Elsayed, Msc principal investigator

Surgical oncology registrar,Alexandria university

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing oncoplastic breast surgery in people with Breast Cancer, run by Alexandria University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence of the Tumor (time frame: a median of 30 months post operative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03900299, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.