Wide Margin vs. Narrow Margin in Postneoadjuvant Lumpectomy

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03417622
• Other study ID #: R.18.02.33
• Status: Recruiting
• Phase: Phase 3
• Start date: August 1, 2019
• Est. completion date: August 1, 2026

Study information

• Verified date: February 2021
• Source: Mansoura University
• Contact: Osama Hussein, MD,PhD,FEBS
• Phone: +2010 9981 5110
• Email: osamahussein[@]mans.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 370
• Est. completion date: August 1, 2026
• Est. primary completion date: August 1, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.
• Pre-treatment volume margin resection
The lumpectomy includes the whole bracketed tissue to take in account the initial tumor extent before systemic therapy.

Locations

Country	Name	City	State
Egypt	Mansoura University Oncology Center	Mansourah	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. Review. — View 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. Epub 2016 Oct 14. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mastectomy rate.	The proportion of patients who undergo mastectomy after failed conservative surgery.	at 6 months from the date of first surgical intervention.
Other	Cosmetic score.	Numeric score description of the cosmetic outcome of breast conservative surgery.	at 6 months from the date of first surgical intervention.
Primary	Local recurrence rate.	The rate of local recurrence at five years.	at 60 months after the date of diagnosis.
Secondary	Local disease-free survival.	The proportion of patients who remain free of local disease recurrence.	up to 60 months from the date of diagnosis.
Secondary	Disease-free survival.	The proportion of patients who remain free of disease recurrence.	up to 60 months from the date of diagnosis.
Secondary	Overall survival.	The proportion of patients who are alive.	up to 60 months from the date of diagnosis.