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]
- Conditions
- Neoplasms
- Registration Number
- KCT0007638
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Female
- Target Recruitment
- 533
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)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease-Free Survival
- Secondary Outcome Measures
Name Time Method Ipsilateral Breast Tumor Recurrence-Free Survival;Overall Survival ;Invasive Disease-Free Survival ;QoL, symptoms, and medical cost;Rate of residual axillary lymph node metastasis on axillary surgery