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

Recruiting N/A Interventional Study
Breast Cancer Invasive
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
20 and older
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
533 (estimated)
Sponsor
Seoul National University Hospital · Other
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Sex: female * Age: 20 years and older * Patients with no clinical/radiologic distant metastasis * Tumor type: Invasive ductal carcinoma * Tumor subtype: HER2 positive(including luminal B type, triple negative * Extent of disease: initial tumor size ≤ 5cm, cN0-2 * Patients with…
Contacts

Han-Byoel Lee

+82-2-2072-3447

hblee80@gmail.com

CONTACT

Hong-Kyu Kim

+82-2-2072-2980

hkkim4592@gmail.com

CONTACT