Preoperative vs. Pathologic Size in Breast Cancer: A Prospective Study
NCT Number: NCT06505577
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Mastectomy|Breast Neoplasm Malignant Primary
Interventions: OTHER: No additional intervention
Sponsor: Incheon St.Mary's Hospital
Collaborators: Yonsei University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 600
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2027-08
Locations: Incheon St. Mary's Hospital, Incheon, Korea, Republic of

Summary:
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.

Primary Outcome Measures: Concordance rate by the intraclass correlation coefficient Factors associated with discrepancies, 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., Within 30 days after surgery
Secondary Outcome Measures: 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), 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., Within 30 days after surgery|Concordance rate and discrepancy factor in ductal carcinoma in situ (DCIS) subgroup, To evaluate the concordance between preoperative tumor size assessments and pathologic measurements in the subgroup of patients with ductal carcinoma in situ (DCIS)., Within 30 days after surgery|Concordance rate and discrepancy factor in neoadjuvant systemic therapy subgroup, To assess the concordance between preoperative tumor size assessments and pathologic measurements in the subgroup of patients who received neoadjuvant systemic therapy, Within 30 days after surgery|Proportion of surgical method change: rates of unnecessary total mastectomy, 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., Within 30 days after surgery|Factors requiring MRI: factors associated with size discrepancy between MRI and mammography (with/without Breast ultrasonography), 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., Within 30 days after surgery|Rate of recurrence within 1-year after breast surgery, The proportion of patients who develop new malignant lesions during the follow-up period within 1 year after breast surgery., Within 1 year after enroll