None listed
Conditions
Interventions
Procedure/Surgery : For patients who are expected to achieve pathologic complete response after neoadjuvant chemothearpy based on MRI findings, we will proceed vacuum-assisted biopsy of the main prima
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-Free Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Korea, Republic of
Contacts
Public ContactHong Kyu Kim
Seoul National University Hospital
Outcome results
None listed