Safety of Breast Coservative Multicenteric Breast CancerNCT06926335
Oncological Safety of Oncoplastic Breast Surgery in Multicentric Breast Cancer
An observational study of Safety of Breast Coservative Multicenteric Breast Cancer and Breast Neoplasms, run by Assiut University at 1 site in Egypt.
Trial summary
The purpose of the study is to evaluate Oncological safety of oncoplastic breast surgery in multicentric breast cancer Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Safety of Breast Coservative Multicenteric Breast Cancer, Breast Neoplasms, Breast Cancer
- What is being tested?
- Breast consevative surgery
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Mar 2025to 19 Apr 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- Women only
- Adult, Older adult
Study population: Patients of multicentric breast cancer underwent oncoplastic breast surgery from 2020 to 2025
Who may be able to join
- Female patients with multicentric breast cancer
- Female Patient aged from 18 to 65 years old
- Patients who are fit for general anesthesia.
- Patients who provide a written informed consent.
- Patient who agree to provide short term outcome data and agree to provide contact information to provide contact information
Who cannot join
- Female patients less than 20 years old
- Stage 4 breast cancer
- Patients who are contraindicated for radiotherapy
- Pregnant patients in first trimester
- Patient with inflammatory carcinoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oncological Safety of Oncoplastic Breast Surgery in Multicentric Breast Retrospective Study
The purpose of the study is to evaluate Oncological safety of oncoplastic breast surgery in multicentric breast cancer
Read the detailed description
Breast cancer is the most prevalent cancer in women worldwide, accounting for about 23.8%. Multifocal and multicentric breast tumors are defined as two or more neoplasms separated in one breast. In multifocal tumors, a quarter of the breast is involved while in multicentric tumors, two quarters or more are involved. There is no exact radiological definition, but the distance between the multifocal tumors is less than or equal to 5 cm, whereas the distance between multicentric tumors is 5 cm, or more.
Due to increasingly use of more developed imaging methods such as tomosynthesis, magnetic resonance imaging (MRI) in these patients, we face more MF/MC breast cancer cases. It is seen that MF/MC breast cancer incidence ranges from 6% to 75% in different series.
Breast-conserving surgery (BCS) and radiotherapy have been adopted as the main treatment methods for early breast cancer. However, there are some studies stating that BCS carries risks for local recurrence in patients with MF/MC breast cancer.
Oncoplastic breast conservation (OBC) relies on applying plastic surgery principles within the context of sound oncological resection. Volume-reducing or volume- replacing methods are utilised to optimise postoperative appearances whilst prioritizing negative margin resection, supported by prompt adjuvant therapy. In fact, it is agreed that in cases where more than 20% of the breast tissue must be excised for oncological margin clearance, oncoplastic surgery is likely to require more complex techniques.This may allow larger specimens to be resected than in traditional breast conservation surgery, but with comparable histopathological properties to those who would be offered mastectomy.
Previous work has suggested that as such, OBC should be regarded as a separate entity from breast conservation therapy, and that direct comparison with mastectomy outcomes should be performed to inform decision-making amongst clinicians and with patients when planning for surgery.
- Conditions
- Safety of Breast Coservative Multicenteric Breast Cancer, Breast Neoplasms, Breast Cancer, Multicentric
- Being tested
- Breast consevative surgery
- Keywords
- Breast conservative 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.
Breast consevative surgeryProcedure or surgery
plastic surgery principles within the context of sound oncological resection. Volume-reducing or volume- replacing methods are utilised to optimise postoperative appearances whilst prioritizing negative margin resection, supported by prompt adjuvant therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate Oncological safety of oncoplastic breast surgery in multicentric breast cancer
Number of multicentric breast cancer who underwent breast conservative surgery with no recurrance
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start19 Mar 2025
- Primary completion1 May 2025 (estimated)
- Study completion19 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety of Breast Coservative Multicenteric Breast CancerStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 30 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alshymaa Abd-Elhars Ebrahem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06926335
- Sponsor's protocol ID
- Breast conserve
- Status last verified
- Mar 2025
- First submitted
- 1 Apr 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oncological Safety of Oncoplastic Breast Surgery in Multicentric Breast Retrospective Study
- ClinicalTrials.gov ID
- NCT06926335
- Acronym / sponsor ID
- Breast conserve
- Conditions
- Safety of Breast Coservative Multicenteric Breast Cancer, Breast Neoplasms, Breast Cancer, Multicentric
- Keywords
- Breast conservative surgery
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 19 Apr 2026 (estimated)
- First posted
- 13 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate Oncological safety of oncoplastic breast surgery in multicentric breast cancer
Detailed description
Breast cancer is the most prevalent cancer in women worldwide, accounting for about 23.8%. Multifocal and multicentric breast tumors are defined as two or more neoplasms separated in one breast. In multifocal tumors, a quarter of the breast is involved while in multicentric tumors, two quarters or more are involved. There is no exact radiological definition, but the distance between the multifocal tumors is less than or equal to 5 cm, whereas the distance between multicentric tumors is 5 cm, or more.
Due to increasingly use of more developed imaging methods such as tomosynthesis, magnetic resonance imaging (MRI) in these patients, we face more MF/MC breast cancer cases. It is seen that MF/MC breast cancer incidence ranges from 6% to 75% in different series.
Breast-conserving surgery (BCS) and radiotherapy have been adopted as the main treatment methods for early breast cancer. However, there are some studies stating that BCS carries risks for local recurrence in patients with MF/MC breast cancer.
Oncoplastic breast conservation (OBC) relies on applying plastic surgery principles within the context of sound oncological resection. Volume-reducing or volume- replacing methods are utilised to optimise postoperative appearances whilst prioritizing negative margin resection, supported by prompt adjuvant therapy. In fact, it is agreed that in cases where more than 20% of the breast tissue must be excised for oncological margin clearance, oncoplastic surgery is likely to require more complex techniques.This may allow larger specimens to be resected than in traditional breast conservation surgery, but with comparable histopathological properties to those who would be offered mastectomy.
Previous work has suggested that as such, OBC should be regarded as a separate entity from breast conservation therapy, and that direct comparison with mastectomy outcomes should be performed to inform decision-making amongst clinicians and with patients when planning for surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patients of multicentric breast cancer underwent oncoplastic breast surgery from 2020 to 2025
Key inclusion criteria (5 listed)
- Female patients with multicentric breast cancer
- Female Patient aged from 18 to 65 years old
- Patients who are fit for general anesthesia.
- Patients who provide a written informed consent.
- Patient who agree to provide short term outcome data and agree to provide contact information to provide contact information
Key exclusion criteria (5 listed)
- Female patients less than 20 years old
- Stage 4 breast cancer
- Patients who are contraindicated for radiotherapy
- Pregnant patients in first trimester
- Patient with inflammatory carcinoma
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 |
|---|---|---|
| Breast consevative surgeryplastic surgery principles within the context of sound oncological resection. Volume-reducing or volume- replacing methods are utilised to optimise postoperative appearances whilst prioritizing negative margin resection, supported by prompt adjuvant therapy | Procedure or surgery | – |
Primary outcome
To evaluate Oncological safety of oncoplastic breast surgery in multicentric breast cancer
Time frame: 5 years
Number of multicentric breast cancer who underwent breast conservative surgery with no recurrance
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Safety of Breast Coservative Multicenteric Breast Cancer and Breast Neoplasms, run by Assiut 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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 17 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
To evaluate Oncological safety of oncoplastic breast surgery in multicentric breast cancer (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2025.