RecruitingNot ApplicableNCT05505357

Omission of Breast Surgery for Breast Cancer Patients With pCR on MRI and Vacuum-assisted Biopsy After NST (OPTIMIST)

Omission of Breast Surgery for Predicted Pathologic Complete Response Patients With MRI and Vacuum-assisted bIopsy in Breast Cancer After Neoadjuvant Systemic Therapy: a Multicenter, Single-arm, Non-inferiority Trial


Sponsor

Seoul National University Hospital

Enrollment

533 participants

Start Date

Sep 22, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

A prospective, multicenter, single-arm non-inferiority trial to demonstrate that breast cancer patients who are predicted to have a pathologic complete response on MRI and vacuum-assisted biopsy after neoadjuvant systemic therapy, and are omitted breast surgery have a non-inferior 5-year disease-free survival compared to those who had received breast surgery.


Eligibility

Sex: FEMALEMin Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring whether women with breast cancer who respond very well to pre-surgery chemotherapy — so well that scans and biopsies show no remaining tumor — can safely skip breast surgery altogether. Instead of surgery, researchers will use MRI and needle biopsy to confirm the cancer is gone. **You may be eligible if...** - You are a woman aged 20 or older - You have been diagnosed with HER2-positive or triple-negative invasive ductal carcinoma (a specific type of breast cancer) - Your initial tumor was 5 cm or smaller with no widespread lymph node spread - Your MRI after chemotherapy shows very little or no remaining tumor - A small metal clip was placed in your tumor before or during chemotherapy - You have no signs of cancer spread to other parts of the body **You may NOT be eligible if...** - You have cancer in multiple spots in the same breast, or cancer in both breasts - You carry a BRCA gene mutation - You want to have breast surgery - You have had another cancer in the last 5 years - You are allergic to MRI contrast dye - You have inflammatory breast 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

PROCEDUREBreast surgery omission

For patients who are expected to achieve pathologic complete response after neoadjuvant chemotherapy based on MRI findings, vacuum-assisted biopsy will be performed on the main primary lesion marked with a clip. In case of pCR on vacuum-assisted biopsy specimen, breast surgery will be omitted.


Locations(1)

Seoul National University Hospital

Seoul, South Korea

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NCT05505357


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