Wide Margin vs. Narrow Margin in Postneoadjuvant Lumpectomy

NCT03417622 | Recruiting Phase 3

• 1 other identifier: R.18.02.33
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

resection margin; neoadjuvant therapy; breast conservative surgery; locally advanced breast cancer

Outcome Measures

Primary Outcomes (1)

• Local recurrence rate.

  The rate of local recurrence at five years.

  at 60 months after the date of diagnosis.

Secondary Outcomes (3)

• Local disease-free survival.

  up to 60 months from the date of diagnosis.

• Disease-free survival.

  up to 60 months from the date of diagnosis.

• Overall survival.

  up to 60 months from the date of diagnosis.

Other Outcomes (2)

• Mastectomy rate.

  at 6 months from the date of first surgical intervention.

• Cosmetic score.

  at 6 months from the date of first surgical intervention.

Study Arms (2)

Post-treatment volume-resection margin

EXPERIMENTAL

Lumpectomy is performed with resection margin of the clinically / radiologically identifiable post-treatment tumor.

Procedure: Bracketing; Drug: Neoadjuvant therapy; Procedure: Post-treatment volume margin resection

Pre-treatment volume-resection margin

ACTIVE COMPARATOR

Lumpectomy is performed with resection margin of the bracketed tissue.

Procedure: Bracketing; Drug: Neoadjuvant therapy; Procedure: Pre-treatment volume margin resection

Interventions

Bracketing PROCEDURE

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.

Post-treatment volume-resection margin; Pre-treatment volume-resection margin

Neoadjuvant therapy DRUG

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.

Post-treatment volume-resection margin; Pre-treatment volume-resection margin

Post-treatment volume margin resection PROCEDURE

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.

Post-treatment volume-resection margin

Pre-treatment volume margin resection PROCEDURE

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

Pre-treatment volume-resection margin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Oncology Center

Al Mansurah, DK, 35516, Egypt

RECRUITING

Related Publications (2)

• 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.

  PMID: 27920628 BACKGROUND

• 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.

  PMID: 28559767 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Margins of Excision

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Central Study Contacts

Osama Hussein, MD,PhD,FEBS

CONTACT

+2010 9981 5110; osamahussein@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of surgery (surgical oncology)

Study Record Dates

• First Submitted: January 24, 2018
• First Posted: January 31, 2018
• Study Start: August 1, 2019
• Primary Completion: August 1, 2026
• Study Completion: August 1, 2026
• Last Updated: February 25, 2021

Record last verified: 2021-02

Locations

EG (1)