Actively Recruiting
Omission of Breast Surgery for Breast Cancer Patients With pCR on MRI and Vacuum-assisted Biopsy After NST (OPTIMIST)
Led by Seoul National University Hospital · Updated on 2024-02-28
533
Participants Needed
1
Research Sites
453 weeks
Total Duration
On this page
Sponsors
S
Seoul National University Hospital
Lead Sponsor
M
Ministry of Health & Welfare, Korea
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Omission of Breast Surgery for Breast Cancer Patients With pCR on MRI and Vacuum-assisted Biopsy After NST (OPTIMIST)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female sex
- Age 20 years or older
- No clinical or radiologic distant metastasis
- Invasive ductal carcinoma tumor type
- HER2 positive tumor subtype (including luminal B type, triple negative)
- Initial tumor size 5 cm or less, clinical node status cN0-2
- Measurable tumor size
- Expected to achieve pathologic complete response after neoadjuvant chemotherapy (MRI size 1.0 cm or less AND lesion-to-background parenchymal signal enhancement ratio of 1.6 or less)
- Clip inserted at the primary tumor site before or during neoadjuvant chemotherapy
- Able to give informed consent and make voluntary decisions
You will not qualify if you...
- Two or more tumor lesions (multifocal lesion)
- Residual microcalcification greater than 2 cm after neoadjuvant chemotherapy
- Bilateral breast cancer or inflammatory breast cancer
- Contraindication to radiotherapy
- History of previous contralateral breast cancer
- Breast cancer with distant metastasis
- Allergy to MRI contrast agents
- Male breast cancer
- Unable to give informed consent due to poor general condition
- BRCA mutation carrier
- Willingness to receive breast surgery
- History of cancer diagnosis within 5 years (except for non-melanoma skin cancer and ductal carcinoma in situ)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
Research Team
H
Han-Byoel Lee
CONTACT
H
Hong-Kyu Kim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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