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

Recruiting now · Not applicable

Conditions studied: Breast Cancer Invasive

In brief

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.

Key facts

Study ID

NCT05505357

Run by

Seoul National University Hospital

People needed

533

Starts

2022-09-22

Expected to finish

2031-06-01

Last updated by the study team

2024-02-28

Who can join

Age: 20 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Seoul National University Hospital — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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