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

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 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
* 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)

Conditions3

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