Comparing wide and narrow margins in breast cancer surgery after chemotherapy
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
This study is testing whether using different surgical margins based on tumor size before or after chemotherapy can help reduce the chances of breast cancer coming back in patients who have had treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 370 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Mansoura University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Al Mansurah, DK) |
| Trial ID | NCT03417622 on ClinicalTrials.gov |
What this trial studies
This trial investigates the optimal extent of surgical resection margins in breast cancer patients who have undergone neoadjuvant therapy. It aims to determine whether planning the resection margin based on the tumor size before treatment leads to better local recurrence rates compared to margins based on post-treatment tumor size. The study will involve patients with invasive breast cancer who meet specific eligibility criteria, and it will compare outcomes between two different surgical approaches. The findings could provide evidence to guide surgical practices in breast conservation therapy.
Who should consider this trial
Good fit: Ideal candidates are patients with biopsy-proven invasive adenocarcinoma of the breast who are eligible for breast-conserving surgery after neoadjuvant therapy.
Not a fit: Patients opting for mastectomy or those with metastatic disease or multifocal tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced recurrence rates for breast cancer patients undergoing conservative surgery after chemotherapy.
How similar studies have performed: While there is ongoing debate regarding optimal resection margins in breast cancer surgery, this specific approach has not been extensively tested in prior studies, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Al Mansurah, DK
- Mansoura University Oncology Center — Al Mansurah, Dk, Egypt (Recruiting)
Study contacts
- Study coordinator: Osama Hussein, MD,PhD,FEBS
- Email: osamahussein@mans.edu.eg
- Phone: +2010 9981 5110
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.