Breast CancerPhase 3NCT03417622
Wide Margin vs. Narrow Margin in Postneoadjuvant Lumpectomy
A Phase 3 study testing Bracketing, Neoadjuvant therapy and Post-treatment volume margin resection in people with Breast Cancer, run by Mansoura University at 1 site in Egypt.
Trial summary
Breast cancer patients often receive systemic drugs as the initial curative treatment of their disease. The initial systemic therapy leads to a variable degree of tumor shrinkage. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Bracketing, Neoadjuvant therapy and Post-treatment volume margin resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2019to 1 Aug 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy-proven diagnosis of invasive adenocarcinoma of the breast.
- Tumor stage T 1-4b
- Nodal stage N 0-2
- ASA (American Society of Anesthesiologists) class I-II
Who cannot join
- Patients opting for mastectomy.
- Patients advised for mastectomy by the treating physician.
- Patients opting for primary surgical treatment.
- Patients advised for primary surgical treatment by the treating physician.
- Metastatic patients.
- Multifocal tumors.
Show all 9Show fewer
- Lobular neoplasia.
- Current pregnancy or pregnancy less than 6 months from the enrollment date.
- Active second cancer.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University Oncology Center
Al Mansurah, DK, 35516
Osama Hussein, MD,PhD,FEBS, +2010 9981 5110, osamahussein@mans.edu.eg
Aiman El-Saed, MD,PhD
About this study
Official title: Surgical Resection Margin According to the Post-treatment Tumor Volume Versus the Pre-treatment Tumor Volume in Breast Conservative Surgery for Invasive Breast Cancer Patients Receiving Primary Systemic Therapy: Randomized Controlled Trial
Breast cancer patients often receive systemic drugs as the initial curative treatment of their disease. The initial systemic therapy leads to a variable degree of tumor shrinkage. At present, there is no evidence-based consensus among breast surgeons on the optimal extent of resection after considerable tumor shrinkage and whether resection margin should be designed according to the tumor extent before treatment or the extent after treatment. This trial will help determine the optimal extent of resection in tumors that exhibits a significant change in volume after primary systemic therapy.
Read the detailed description
Primary systemic (neoadjuvant) therapy (NAT) is a widely practised curative treatment for invasive breast cancer. Neoadjuvant chemotherapy (before surgery) and adjuvant chemotherapy (after surgery) had equivalent survival rates in major randomized trials. In these studies, preoperative systemic therapy increased the patient's chance to achieve breast conservation. The down side was a clear trend towards increased ipsilateral breast tumor recurrence. Preoperative chemotherapy leads to patchy, irregular cell death known as honeycomb effect and thus may lead to a misleading false negative resection margin of a tumorectomy operation. Even with the advent of oncoplastic techniques which allowed larger resection volumes with satisfactory cosmetic results, rates of re-excision, mastectomy and local relapse did not differ from those after traditional lumpectomy operations. As of today, there is no consensus -based on evidence- on the optimal width of margin in patients who are offered breast conservative surgery (BCS) after systemic therapy. In view of the current uncertainty and lack of evidence, The present trial is designed to answer the following question (Specific aim): Does planning the resection margin according to the pre-treatment tumor extent improve the local recurrence rate in patients receiving breast conservative surgery after systemic therapy?
- Conditions
- Breast Cancer
- Being tested
- Bracketing, Neoadjuvant therapy, Post-treatment volume margin resection, Pre-treatment volume margin resection
- Keywords
- resection margin, neoadjuvant therapy, breast conservative surgery, locally advanced breast cancer
- Medical subject headings
- Breast Neoplasms, Margins of Excision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BracketingProcedure or surgery
At the beginning of therapy, ultrasonographic examination is used to measure the tumor in three dimensions and bracket the tumor using 4-6 metal clips which will serve as markers for the initial tumor extent in case of tumor shrinkage in response to systemic treatment.
All patients will receive primary systemic therapy according to the current institutional guidelines. Drugs include cytotoxic chemotherapy, hormonal therapy and/or anti-HER2/neu therapy as indicated.
Post-treatment volume margin resectionProcedure or surgery
The lumpectomy resection margin is planned according to the identifiable tumor at operation. The initial extent of the tumor at diagnosis is not taken in account. If there is complete clinical response to systemic therapy (i.e. no identifiable tumor), the center of the bracketed tissue is biopsied.
Pre-treatment volume margin resectionProcedure or surgery
The lumpectomy includes the whole bracketed tissue to take in account the initial tumor extent before systemic therapy.
| Study group | Role | What they receive |
|---|---|---|
| Post-treatment volume-resection margin | Experimental | Lumpectomy is performed with resection margin of the clinically / radiologically identifiable post-treatment tumor. Receives: Procedure: Bracketing; Drug: Neoadjuvant therapy; Procedure: Post-treatment volume margin resection |
| Pre-treatment volume-resection margin | Active comparator | Lumpectomy is performed with resection margin of the bracketed tissue. Receives: Procedure: Bracketing; Drug: Neoadjuvant therapy; Procedure: Pre-treatment volume margin resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local recurrence rate.
The rate of local recurrence at five years.
Measured: at 60 months after the date of diagnosis.
Secondary outcomes (3)
Local disease-free survival.
The proportion of patients who remain free of local disease recurrence.
Measured: up to 60 months from the date of diagnosis.
Disease-free survival.
The proportion of patients who remain free of disease recurrence.
Measured: up to 60 months from the date of diagnosis.
Overall survival.
The proportion of patients who are alive.
Measured: up to 60 months from the date of diagnosis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start1 Aug 2019
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Hussein, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03417622
- Sponsor's protocol ID
- R.18.02.33
- Status last verified
- Feb 2021
- First submitted
- 24 Jan 2018
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhou X, Li Y. Local Recurrence after Breast-Conserving Surgery and Mastectomy Following Neoadjuvant Chemotherapy for Locally Advanced Breast Cancer - a Meta-Analysis. Breast Care (Basel). 2016 Oct;11(5):345-351. doi: 10.1159/000450626. Epub 2016 Oct 14.
PubMed 27920628Gnant M, Harbeck N, Thomssen C. St. Gallen/Vienna 2017: A Brief Summary of the Consensus Discussion about Escalation and De-Escalation of Primary Breast Cancer Treatment. Breast Care (Basel). 2017 May;12(2):102-107. doi: 10.1159/000475698. Epub 2017 Apr 26.
PubMed 28559767
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Resection Margin According to the Post-treatment Tumor Volume Versus the Pre-treatment Tumor Volume in Breast Conservative Surgery for Invasive Breast Cancer Patients Receiving Primary Systemic Therapy: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03417622
- Acronym / sponsor ID
- R.18.02.33
- Conditions
- Breast Cancer
- Keywords
- resection margin, neoadjuvant therapy, breast conservative surgery, locally advanced breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 31 Jan 2018 (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.
Breast cancer patients often receive systemic drugs as the initial curative treatment of their disease. The initial systemic therapy leads to a variable degree of tumor shrinkage. At present, there is no evidence-based consensus among breast surgeons on the optimal extent of resection after considerable tumor shrinkage and whether resection margin should be designed according to the tumor extent before treatment or the extent after treatment. This trial will help determine the optimal extent of resection in tumors that exhibits a significant change in volume after primary systemic therapy.
Detailed description
Primary systemic (neoadjuvant) therapy (NAT) is a widely practised curative treatment for invasive breast cancer. Neoadjuvant chemotherapy (before surgery) and adjuvant chemotherapy (after surgery) had equivalent survival rates in major randomized trials. In these studies, preoperative systemic therapy increased the patient's chance to achieve breast conservation. The down side was a clear trend towards increased ipsilateral breast tumor recurrence. Preoperative chemotherapy leads to patchy, irregular cell death known as honeycomb effect and thus may lead to a misleading false negative resection margin of a tumorectomy operation. Even with the advent of oncoplastic techniques which allowed larger resection volumes with satisfactory cosmetic results, rates of re-excision, mastectomy and local relapse did not differ from those after traditional lumpectomy operations. As of today, there is no consensus -based on evidence- on the optimal width of margin in patients who are offered breast conservative surgery (BCS) after systemic therapy. In view of the current uncertainty and lack of evidence, The present trial is designed to answer the following question (Specific aim): Does planning the resection margin according to the pre-treatment tumor extent improve the local recurrence rate in patients receiving breast conservative surgery after systemic therapy?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-treatment volume-resection margin | Experimental | Procedure: Bracketing, Drug: Neoadjuvant therapy, Procedure: Post-treatment volume margin resectionLumpectomy is performed with resection margin of the clinically / radiologically identifiable post-treatment tumor. |
| Pre-treatment volume-resection margin | Active comparator | Procedure: Bracketing, Drug: Neoadjuvant therapy, Procedure: Pre-treatment volume margin resectionLumpectomy is performed with resection margin of the bracketed tissue. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Biopsy-proven diagnosis of invasive adenocarcinoma of the breast.
- Tumor stage T 1-4b
- Nodal stage N 0-2
- ASA (American Society of Anesthesiologists) class I-II
Key exclusion criteria (9 listed)
- Patients opting for mastectomy.
- Patients advised for mastectomy by the treating physician.
- Patients opting for primary surgical treatment.
- Patients advised for primary surgical treatment by the treating physician.
- Metastatic patients.
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 |
|---|---|---|
| BracketingAt the beginning of therapy, ultrasonographic examination is used to measure the tumor in three dimensions and bracket the tumor using 4-6 metal clips which will serve as markers for the initial tumor extent in case of tumor shrinkage in response to systemic treatment. | Procedure or surgery | Post-treatment volume-resection margin, Pre-treatment volume-resection margin |
| Neoadjuvant therapyAll patients will receive primary systemic therapy according to the current institutional guidelines. Drugs include cytotoxic chemotherapy, hormonal therapy and/or anti-HER2/neu therapy as indicated. | Drug | Post-treatment volume-resection margin, Pre-treatment volume-resection margin |
| Post-treatment volume margin resectionThe lumpectomy resection margin is planned according to the identifiable tumor at operation. The initial extent of the tumor at diagnosis is not taken in account. If there is complete clinical response to systemic therapy (i.e. no identifiable tumor), the center of the bracketed tissue is biopsied. | Procedure or surgery | Post-treatment volume-resection margin |
| Pre-treatment volume margin resectionThe lumpectomy includes the whole bracketed tissue to take in account the initial tumor extent before systemic therapy. | Procedure or surgery | Pre-treatment volume-resection margin |
Primary outcome
Local recurrence rate.
Time frame: at 60 months after the date of diagnosis.
The rate of local recurrence at five years.
3 secondary outcomes
Local disease-free survival.
Time frame: up to 60 months from the date of diagnosis.
Disease-free survival.
Time frame: up to 60 months from the date of diagnosis.
Overall survival.
Time frame: up to 60 months from the date of diagnosis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Background: PubMed 27920628Zhou X, Li Y. Local Recurrence after Breast-Conserving Surgery and Mastectomy Following Neoadjuvant Chemotherapy for Locally Advanced Breast Cancer - a Meta-Analysis. Breast Care (Basel). 2016 Oct;11(5):345-351. doi: 10.1159/000450626. Epub 2016 Oct 14.
- Background: PubMed 28559767Gnant M, Harbeck N, Thomssen C. St. Gallen/Vienna 2017: A Brief Summary of the Consensus Discussion about Escalation and De-Escalation of Primary Breast Cancer Treatment. Breast Care (Basel). 2017 May;12(2):102-107. doi: 10.1159/000475698. Epub 2017 Apr 26.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bracketing, Neoadjuvant therapy and Post-treatment volume margin resection in people with Breast Cancer, run by Mansoura 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 4 inclusion and 9 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 25 Feb 2021. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Osama Hussein, MD,PhD,FEBS (+2010 9981 5110, osamahussein@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local recurrence rate. (time frame: at 60 months after the date of diagnosis.). 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 NCT03417622, 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 25 Feb 2021.