Wide Margin vs. Narrow Margin in Postneoadjuvant Lumpectomy
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
Mansoura University
370 participants
Aug 1, 2019
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria9
- 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.
Interventions
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.
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.
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.
The lumpectomy includes the whole bracketed tissue to take in account the initial tumor extent before systemic therapy.
Locations(1)
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NCT03417622