Prediction of Pathologic Complete Response by Multiple Core Needle Biopsy or Vacuum Assisted Biopsy Before Surgery in Breast Cancer With Complete Clinical Response After Neoadjuvant Chemotherapy.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Negative Predictive Value
Study Overview
Brief Summary
The purpose of this study is to evaluate the ability of preoperative biopsy to predict correctly pathologic complete response in breast cancer patients with complete clinical response after neoadjuvant chemotherapy.
Detailed Description
Breast cancer patients who received neoadjuvant chemotherapy and is predicted to have achieved pathologic complete response (pCR) on MRI will enrolled. The enrolled patients will undergo either US-guided multiple core needle biopsy or US-guided vacuum-assisted biopsy of the tumor bed where it had been marked with an indicator (clip). The patient will undergo subsequent wide excision of the tumor bed. Histopathologic findings of the biopsy and the surgical specimen will be compared for pCR, and the ability of preoperative biopsies to predict pCR will be evaluated.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •with unilateral primary cancer pathologically confirmed before neoadjuvant chemotherapy (NAC)
- •who received NAC
- •with detectable lesion / clip marker on ultrasound
- •with cT1-T3 tumors
- •clinical and imaging complete or near-complete response on MRI
- •with informed consent
Exclusion Criteria
- •Multifocal cancer
- •Residual microcalcification
- •Contralateral breast cancer
Arms & Interventions
Core needle Biopsy
Ultrasound-guided core needle biopsy (14G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.
Intervention: Minimally-invasive biopsy (Procedure)
Core needle Biopsy
Ultrasound-guided core needle biopsy (14G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.
Intervention: wide excision (Procedure)
Vacuum-assisted biopsy
Vacuum-assisted biopsy (10G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.
Intervention: Minimally-invasive biopsy (Procedure)
Vacuum-assisted biopsy
Vacuum-assisted biopsy (10G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.
Intervention: wide excision (Procedure)
Outcomes
Primary Outcomes
Negative Predictive Value
Time Frame: 2 weeks
Percentage of participants with pathologic complete response (pCR) confirmed by surgical excision in patients predicted by biopsy to have pCR
Secondary Outcomes
- False Negative Rate(2 weeks)
Investigators
Wonshik Han
Professor
Seoul National University Hospital