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Recruiting Not applicable

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

NCT05505357 · tracked via the Priya Life Science South Korea tracker
Phase
Not applicable
Started
2022-09-22
Last updated
2024-02-28

Condition(s) studied

Breast Cancer Invasive

Investigational drug(s) / intervention(s)

Breast surgery omission

Breast surgery omission: 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.

Study 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

Sex
FEMALE
Min age
20 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Disease-Free Survival — 5 years after axillary surgery or VAB (in case of axillary surgery omission)
    Proportion of patients with no disease recurrence (including loco-regional recurrence, distant metastasis, and contralateral breast cancer) or death.

Trial sites (1)

FacilityCityRegionStatus
Seoul National University Hospital Seoul South Korea Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05505357 on ClinicalTrials.gov ↗ ← All trials in South Korea