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

Seoul National University

Status: Active, not recruiting

Conditions: IMAGE; Chemotherapy Effect; Breast Cancer; Surgery

Treatments: Diagnostic Test: Preoperative imaging study

Study type: Interventional

Funder types: Other

Identifiers

NCT04689529

1711-048-898

Details and patient eligibility

About

• 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.

Full 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.

Enrollment: 360 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 2 patient groups

Breast cancer patients undergoing mastectomy after neoadjuvant chemotherapy

Experimental group

Description:

Patients who underwent total mastectomy (including simultaneous reconstruction surgery) through preoperative examinations (MRI, breast ultrasound, mammography, etc.) after receiving neoadjuvant chemotherapy

Treatment:

Diagnostic Test: Preoperative imaging study

Breast cancer patients without neoadjuvant chemotherapy and undergoing mastectomy

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Preoperative imaging study