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NCT Number: NCT06505577

Preoperative vs. Pathologic Size in Breast Cancer: A Prospective Study

Breast cancer, the most prevalent malignancy among women globally, is increasing in incidence. While non-metastatic breast cancer requires surgery, determining the optimal extent of resection remains challenging. Inadequate resection margins necessitate reoperation, leading to increased psychological stress, costs, and potentially compromised cosmetic outcomes and prognosis.

Accurate preoperative assessment of resection extent is crucial and involves various factors, including imaging studies, physical examinations, tumor molecular subtypes, and intraductal carcinoma components. This prospective observational study aims to identify and integrate multiple predictive factors to enhance surgical planning and minimize reoperation rates in breast cancer patients.

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Key information

Conditions

Mastectomy Adenocarcinoma Breast Carcinoma In Situ Breast Diseases Breast Neoplasm Malignant Primary Breast Neoplasms Carcinoma Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Incheon St. Mary's Hospital

Incheon, South Korea

Location status: Recruiting

Location contact

Jae Pak Yi, MD

SUB_INVESTIGATOR

Young-Joon Kang, MD, PhD

CONTACT

[email protected]

82-32-280-5179

Young-Joon Kang, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

Breast cancer is the most prevalent malignancy among women globally, leading to surgical interventions for non-metastatic cases. While breast cancer generally has a favorable prognosis, achieving negative resection margins at initial surgery is crucial for optimal outcomes. The challenge associated with accurately predicting the extent of resection preoperatively, as failure to secure clear margins may necessitate further resection or total mastectomy, resulting in increased psychological stress, higher healthcare costs, compromised cosmetic results, and potential negative impacts on long-term prognosis and quality of life. Many factors contribute to predicting the optimal resection extent, including imaging studies, physical examination findings, tumor molecular subtypes, presence and extent of intraductal carcinoma components, etc. Despite the availability of these predictive factors, their integration and practical application in clinical decision-making remain challenging. This prospective observational study aims to address this gap by analyzing the interplay of these factors in real-world clinical settings, with the primary objective of deriving an integrated predictive model to guide surgeons in determining the optimal extent of resection preoperatively.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult patients (≥ 19 years old) diagnosed with breast cancer (invasive and in situ).

Patients scheduled for surgical resection of the tumor Availability of both preoperative tumor size assessments and pathologic measurements post-surgery

Exclusion criteria

Patients with recurrent breast cancer Inflammatory breast cancer Patients who did not undergo surgery Patients whose preoperative tumor size data is not available or deficient for analyzing

Treatment and study plan

No additional intervention

Other

All patients are scheduled to undergo standard breast surgery as part of their routine clinical care. No additional interventions are administered specifically for this study.

Primary outcomes

  1. Concordance rate by the intraclass correlation coefficient Factors associated with discrepancies

    Time frame: Within 30 days after surgery

    To assess the concordance between preoperative tumor size assessments made by surgeons and the actual tumor size determined by pathologic analysis following surgical resection in patients with breast cancer.

    • Using the scale of Landis and Koch according to the intraclass correlation coefficient.
    • With/without MRI status. To identify and evaluate factors associated with discrepancies between preoperative assessments and pathologic measurements.

Secondary outcomes

  1. Concordance rate by size discordance (5mm) To evaluate the concordance between preoperative tumor size assessments and pathologic measurements in the subgroup of patients with ductal carcinoma in situ (DCIS)

    Time frame: Within 30 days after surgery

    To assess the concordance between preoperative tumor size assessments made by surgeons and the actual tumor size determined by pathologic analysis following surgical resection in patients with breast cancer. A difference of 5mm or more between preoperative and pathologic measurements is defined as discordance.

  2. Concordance rate and discrepancy factor in ductal carcinoma in situ (DCIS) subgroup

    Time frame: Within 30 days after surgery

    To evaluate the concordance between preoperative tumor size assessments and pathologic measurements in the subgroup of patients with ductal carcinoma in situ (DCIS).

  3. Concordance rate and discrepancy factor in neoadjuvant systemic therapy subgroup

    Time frame: Within 30 days after surgery

    To assess the concordance between preoperative tumor size assessments and pathologic measurements in the subgroup of patients who received neoadjuvant systemic therapy

  4. Proportion of surgical method change: rates of unnecessary total mastectomy

    Time frame: Within 30 days after surgery

    To determine the rate of change in surgical method (e.g., from lumpectomy to mastectomy, nipple-sparing to skin-sparing, or vice versa) based on discrepancies between preoperative tumor size assessments and pathologic measurements. This involves collecting the initial surgical method plan from the surgeon before the surgery and, after confirming the pathological size post-surgery, collecting the final surgical method deemed feasible for the patient from the surgeon.

  5. Factors requiring MRI: factors associated with size discrepancy between MRI and mammography (with/without Breast ultrasonography)

    Time frame: Within 30 days after surgery

    To determine the associated factors contributing to size discrepancies between mammography (with or without breast ultrasonography) and MRI. For analyzing the clinical factors that necessitate the use of MRI to predict the pathologic tumor size.

  6. Rate of recurrence within 1-year after breast surgery

    Time frame: Within 1 year after enroll

    The proportion of patients who develop new malignant lesions during the follow-up period within 1 year after breast surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Young-Joon Kang, Ph.D.

CONTACT

[email protected]

82 32-280-5179

Sponsors and collaborators

Lead sponsor

Incheon St.Mary's Hospital

Other

Collaborators

  • Yonsei University

Registry information

Official study title

Concordance Between Preoperative Assessments and Pathologic Size Measurements in Breast Cancer: a Prospective Observational Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 17, 2024
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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