KCT0007638
Not yet recruiting
未知
Omission of breast surgery for PredicTed pCR patients wIth MRI and vacuum-assisted bIopsy in breaST cancer after neoadjuvant chemotherapy: a multicenter, single-arm, non-inferiority trial [OPTIMIST trial]
ConditionsNeoplasms
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- Seoul National University Hospital
- Enrollment
- 533
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
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 measurable tumor size
- •Patients who are expected to achieve pCR after neoadjuvant chemotherapy (MRI size \= 1\.0 cm AND L\-to\-B SER \= 1\.6\)
- •Patients with clip inserted to the primary tumor site before or during neoadjuvant chemotherapy
- •Patients with informed consent who are competent to make a voluntary decision
Exclusion Criteria
- •Multifocal lesion (\=2\)
- •Extent of residual microcalcification after neoadjuvant chemotherapy \> 2cm
- •Bilateral breast cancer or inflammatory breast cancer
- •Contraindication to radiotherapy
- •History of previous contralateral breast cancer
- •Breast cancer patients with distant metastasis
- •Allergic history to MRI contrast
- •Male breast cancer
- •Patients incapable of giving informed consent owing to poor general conditions
- •Patients with BRCA mutation
Outcomes
Primary Outcomes
Not specified
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