RecruitingPhase 3NCT03417622

Wide Margin vs. Narrow Margin in Postneoadjuvant Lumpectomy

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

Sponsor

Mansoura University

Enrollment

370 participants

Start Date

Aug 1, 2019

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two different surgical approaches for breast cancer patients who receive chemotherapy before surgery (neoadjuvant chemotherapy) — specifically whether removing a wider or narrower margin of healthy tissue around the tumor during a lumpectomy makes a difference in cancer recurrence. **You may be eligible if...** - You have been diagnosed with invasive breast cancer confirmed by biopsy - Your tumor is at stage T1–T4b and your lymph nodes are at stage N0–N2 - You are in generally good health (ASA class I or II) - You are receiving chemotherapy before surgery (neoadjuvant treatment) **You may NOT be eligible if...** - You are having or have been advised to have a full mastectomy - You are choosing surgery without prior chemotherapy - Your cancer has spread to other parts of the body (metastatic) - You have multiple tumor sites in the same breast - You are pregnant or were pregnant less than 6 months ago - You have another active cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBracketing

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.

DRUGNeoadjuvant 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.

PROCEDUREPost-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.

PROCEDUREPre-treatment volume margin resection

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

Locations(1)

Mansoura University Oncology Center

Al Mansurah, DK, Egypt

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NCT03417622

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