Unnecessary Mastectomy Due to False Size Prediction by Preoperative Imaging Studies in Breast Cancer (PUMP)

The Percentage of Unnecessary Mastectomy Due to False Size Prediction by Preoperative Imaging Studies in Breast Cancer Patients Who Underwent Neoadjuvant Chemotherapy

• The surgical method for breast cancer is determined according to the size and location of the remaining lesions after prior chemotherapy.
• There are many patients who were able to undergo partial resection when confirming the final results of patients who underwent total resection after prior chemotherapy.
• Therefore, we would like to investigate whether it is effective to make decisions based on the results of pre-operative tests after prior chemotherapy.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer; Surgery; Chemotherapy Effect; IMAGE
• Intervention / Treatment: Diagnostic test: Preoperative imaging study

Detailed Description

In a study published by Jennifer F. et al., sensitivity to lesions remaining after prior chemotherapy of breast magnetic resonance imaging was measured as 83%, specificity 47%, PPV 47%, NPV 83%, and accuracy 74%. have.

Most of the preoperative examinations after prior chemotherapy have the most confidence in the results of breast magnetic resonance imaging, but there will be other factors to predict this result as there will be differences in the actual postoperative pathology results. .

After prior chemotherapy, total resection was performed, and cases where partial resection is possible in the postoperative pathologic results are prospectively identified and compared and analyzed.

• Study Type: Interventional
• Enrollment (Actual): 360
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jongno-gu
    • Seoul, Jongno-gu, Korea, Republic of, 03080
      • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Breast cancer patients over 20 years of age undergoing surgery at Seoul National University Hospital
• Patients to undergo total mastectomy
• Patients who received neoadjuvant chemotherapy and undergoing total mastectomy were the main subjects, but as a control group, patients who did not receive neoadjuvant chemotherapy but undergoing total mastectomy were included as subjects.

Exclusion Criteria:

• In case of total mastectomy at the request of the patient
• Except for cases where total resection is performed regardless of size because it is a lesion under the areola and is close to the nipple.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Breast cancer patients undergoing mastectomy after neoadjuvant chemotherapy; Patients who underwent total mastectomy (including simultaneous reconstruction surgery) through preoperative examinations (MRI, breast ultrasound, mammography, etc.) after receiving neoadjuvant chemotherapy	Diagnostic test: Preoperative imaging study; MRI, Breast ultrasound sonography, mammography
Active Comparator: Breast cancer patients without neoadjuvant chemotherapy and undergoing mastectomy; Patients who underwent total mastectomy (including simultaneous reconstruction surgery) through preoperative examinations (MRI, breast ultrasound, mammography, etc.) even in patients who did not receive neoadjuvant chemotherapy as a control group.	Diagnostic test: Preoperative imaging study; MRI, Breast ultrasound sonography, mammography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Final pathology report	Comparison of the difference in size of lesions confirmed by preoperative imaging and final pathology results	2 weeks after surgery

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2018
• Primary Completion (Actual): June 30, 2021
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: December 27, 2020
• First Submitted That Met QC Criteria: December 27, 2020
• First Posted (Actual): December 30, 2020

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 22, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 1711-048-898

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No