Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Wide Margin vs. Narrow Margin in Postneoadjuvant Lumpectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03417622
Recruitment Status : Recruiting
First Posted : January 31, 2018
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Osama Hussein, Mansoura University

Tracking Information
First Submitted Date  ICMJE January 24, 2018
First Posted Date  ICMJE January 31, 2018
Last Update Posted Date September 16, 2019
Actual Study Start Date  ICMJE August 1, 2019
Estimated Primary Completion Date August 1, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2018)
Local recurrence rate. [ Time Frame: at 60 months after the date of diagnosis. ]
The rate of local recurrence at five years.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2018)
  • Local disease-free survival. [ Time Frame: up to 60 months from the date of diagnosis. ]
    The proportion of patients who remain free of local disease recurrence.
  • Disease-free survival. [ Time Frame: up to 60 months from the date of diagnosis. ]
    The proportion of patients who remain free of disease recurrence.
  • Overall survival. [ Time Frame: up to 60 months from the date of diagnosis. ]
    The proportion of patients who are alive.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 30, 2018)
  • Mastectomy rate. [ Time Frame: at 6 months from the date of first surgical intervention. ]
    The proportion of patients who undergo mastectomy after failed conservative surgery.
  • Cosmetic score. [ Time Frame: at 6 months from the date of first surgical intervention. ]
    Numeric score description of the cosmetic outcome of breast conservative surgery.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Wide Margin vs. Narrow Margin in Postneoadjuvant Lumpectomy
Official Title  ICMJE 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
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?
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Post-treatment volume-resection margin
    Lumpectomy is performed with resection margin of the clinically / radiologically identifiable post-treatment tumor.
    Interventions:
    • Procedure: Bracketing
    • Drug: Neoadjuvant therapy
    • Procedure: Post-treatment volume margin resection
  • Active Comparator: Pre-treatment volume-resection margin
    Lumpectomy is performed with resection margin of the bracketed tissue.
    Interventions:
    • Procedure: Bracketing
    • Drug: Neoadjuvant therapy
    • Procedure: Pre-treatment volume margin resection
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 30, 2018)
370
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2026
Estimated Primary Completion Date August 1, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Osama Hussein, MD,PhD,FEBS +2010 9981 5110 osamahussein@mans.edu.eg
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03417622
Other Study ID Numbers  ICMJE R.18.02.33
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Osama Hussein, Mansoura University
Study Sponsor  ICMJE Mansoura University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mansoura University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP