Omission of Breast Surgery for Breast Cancer Patients With pCR on MRI and Vacuum-assisted Biopsy After NST (OPTIMIST)
Recruiting · NCT05505357 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Breast surgery omission
What this trial is about
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.
Who can take part
Age range
20 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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)
Where it is running
1 location listed.
- Seoul National University Hospital - Seoul, South Korea