Clinical trial NCT03417622: Wide Margin vs. Narrow Margin in Postneoadjuvant Lumpectomy
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Breast Cancer
Keywords: resection margin
neoadjuvant therapy
breast conservative surgery
locally advanced breast cancer
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2018-01-31
Enrollment: 370
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Primary systemic (neoadjuvant) therapy (NAT) is a widely practised curative treatment for invasive breast cancer. Neoadjuvant chemotherapy (before surgery) and adjuvant chemotherapy (after surgery) had equivalent survival rates in major randomized trials. In these studies, preoperative systemic therapy increased the patient's chance to achieve breast conservation. The down side was a clear trend towards increased ipsilateral breast tumor recurrence. Preoperative chemotherapy leads to patchy, irregular cell death known as honeycomb effect and thus may lead to a misleading false negative resection margin of a tumorectomy operation. Even with the advent of oncoplastic techniques which allowed larger resection volumes with satisfactory cosmetic results, rates of re-excision, mastectomy and local relapse did not differ from those after traditional lumpectomy operations. As of today, there is no consensus -based on evidence- on the optimal width of margin in patients who are offered breast conservative surgery (BCS) after systemic therapy. In view of the current uncertainty and lack of evidence, The present trial is designed to answer the following question (Specific aim): Does planning the resection margin according to the pre-treatment tumor extent improve the local recurrence rate in patients receiving breast conservative surgery after systemic therapy?

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 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.

Primary outcomes:
measure: Local recurrence rate.
timeFrame: at 60 months after the date of diagnosis.
Secondary outcomes:
measure: Local disease-free survival.
timeFrame: up to 60 months from the date of diagnosis.
measure: Disease-free survival.
timeFrame: up to 60 months from the date of diagnosis.
measure: Overall survival.
timeFrame: up to 60 months from the date of diagnosis.
Other outcomes:
measure: Mastectomy rate.
timeFrame: at 6 months from the date of first surgical intervention.
measure: Cosmetic score.
timeFrame: at 6 months from the date of first surgical intervention.
Locations:
city: Mansourah
country: Egypt
facility: Mansoura University Oncology Center
state: DK
Study officials:
References:
citation: Zhou X, Li Y. Local Recurrence after Breast-Conserving Surgery and Mastectomy Following Neoadjuvant Chemotherapy for Locally Advanced Breast Cancer - a Meta-Analysis. Breast Care (Basel). 2016 Oct;11(5):345-351. doi: 10.1159/000450626. Epub 2016 Oct 14.
citation: Gnant M, Harbeck N, Thomssen C. St. Gallen/Vienna 2017: A Brief Summary of the Consensus Discussion about Escalation and De-Escalation of Primary Breast Cancer Treatment. Breast Care (Basel). 2017 May;12(2):102-107. doi: 10.1159/000475698. Epub 2017 Apr 26.