Wide Margin vs. Narrow Margin in Postneoadjuvant Lumpectomy

PHASE3RecruitingINTERVENTIONAL
Enrollment

370

Participants

Timeline

Start Date

August 1, 2019

Primary Completion Date

August 1, 2026

Study Completion Date

August 1, 2026

Conditions
Breast Cancer
Interventions
PROCEDURE

Bracketing

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.

DRUG

Neoadjuvant therapy

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.

PROCEDURE

Post-treatment volume margin resection

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.

PROCEDURE

Pre-treatment volume margin resection

The lumpectomy includes the whole bracketed tissue to take in account the initial tumor extent before systemic therapy.

Trial Locations (1)

35516

RECRUITING

Mansoura University Oncology Center, Al Mansurah

All Listed Sponsors
lead

Mansoura University

OTHER

NCT03417622 - Wide Margin vs. Narrow Margin in Postneoadjuvant Lumpectomy | Biotech Hunter | Biotech Hunter