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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

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Bracketing Drug: Neoadjuvant therapy Procedure: Post-treatment volume margin resection Procedure: Pre-treatment volume margin resection Phase 3

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?

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 370 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 1, 2026
Estimated Study Completion Date : August 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Post-treatment volume-resection margin
Lumpectomy is performed with resection margin of the clinically / radiologically identifiable post-treatment tumor.
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.

Active Comparator: Pre-treatment volume-resection margin
Lumpectomy is performed with resection margin of the bracketed tissue.
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: Pre-treatment volume margin resection
The lumpectomy includes the whole bracketed tissue to take in account the initial tumor extent before systemic therapy.




Primary Outcome Measures :
  1. Local recurrence rate. [ Time Frame: at 60 months after the date of diagnosis. ]
    The rate of local recurrence at five years.


Secondary Outcome Measures :
  1. 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.

  2. Disease-free survival. [ Time Frame: up to 60 months from the date of diagnosis. ]
    The proportion of patients who remain free of disease recurrence.

  3. Overall survival. [ Time Frame: up to 60 months from the date of diagnosis. ]
    The proportion of patients who are alive.


Other Outcome Measures:
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417622


Contacts
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Contact: Osama Hussein, MD,PhD,FEBS +2010 9981 5110 osamahussein@mans.edu.eg

Locations
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Egypt
Mansoura University Oncology Center Recruiting
Mansourah, DK, Egypt, 35516
Contact: Osama Hussein, MD,PhD,FEBS    +2010 9981 5110    osamahussein@mans.edu.eg   
Sub-Investigator: Aiman El-Saed, MD,PhD         
Sub-Investigator: Maha El-Zaafarany, MD         
Sponsors and Collaborators
Mansoura University
Publications:
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Responsible Party: Osama Hussein, Professor of surgery (surgical oncology), Mansoura University
ClinicalTrials.gov Identifier: NCT03417622    
Other Study ID Numbers: R.18.02.33
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Osama Hussein, Mansoura University:
resection margin
neoadjuvant therapy
breast conservative surgery
locally advanced breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases