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

Who is this study for? Patients with Breast Cancer
What treatments are being studied? Bracketing+Neoadjuvant Therapy+Post-Treatment Volume Margin Resection
Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Egypt
Mansoura University Oncology Center
RECRUITING
Al Mansurah
Contact Information
Primary
Osama Hussein, MD,PhD,FEBS
osamahussein@mans.edu.eg
+2010 9981 5110
Time Frame
Start Date: 2019-08-01
Estimated Completion Date: 2026-08-01
Participants
Target number of participants: 370
Treatments
Experimental: Post-treatment volume-resection margin
Lumpectomy is performed with resection margin of the clinically / radiologically identifiable post-treatment tumor.
Active_comparator: Pre-treatment volume-resection margin
Lumpectomy is performed with resection margin of the bracketed tissue.
Related Therapeutic Areas
Sponsors
Leads: Mansoura University

This content was sourced from clinicaltrials.gov