Wide Margin vs. Narrow Margin in Postneoadjuvant Lumpectomy (NCT03417622) | Clinical Trial Compass
RecruitingPhase 3
Wide Margin vs. Narrow Margin in Postneoadjuvant Lumpectomy
Egypt370 participantsStarted 2019-08-01
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
* Lobular neoplasia.
* Current pregnancy or pregnancy less than 6 months from the enrollment date.
* Active second cancer.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Local recurrence rate.
Timeframe: at 60 months after the date of diagnosis.