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
Seoul National University Hospital
533 participants
Sep 22, 2022
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
Inclusion Criteria10
- 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 Criteria12
- 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
- Patients willing to receive breast surgery
- Patients with a history of cancer diagnosis within 5 years (However, skin cancer other than melanoma and breast carcinoma in situ other than ductal carcinoma in situ can be registered even if 5 years have not passed since the diagnosis)
Interventions
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)
View Full Details on ClinicalTrials.gov
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NCT05505357