Wide Margin vs. Narrow Margin in Postneoadjuvant Lumpectomy
Recruiting
Phase 3
Interventional Study
Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 370 (estimated)
- Sponsor
- Mansoura University · Other
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About This 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 b…
Trial Locations
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Eligibility 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 physici…
Contacts