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]

Seoul National University Hospital0 个研究点目标入组 533 人开始时间: 待定最近更新: 2022年9月20日

适应症

试验速览

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•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

•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)

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