N/A N=40 Diagnostic

Prediction of pCR by Preoperative Biopsy in Breast Cancer With cCR After Neoadjuvant Chemotherapy.

Breast Neoplasm

Bottom Line

View on ClinicalTrials.gov: NCT03273426 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2020

Primary outcome: Primary: Negative Predictive Value — 88.2; 85.7; 87.1 percentage of participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Minimally-invasive biopsy (Procedure); wide excision (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Seoul National University Hospital
Primary completion: Feb 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Negative Predictive Value	88.2; 85.7; 87.1	—
SECONDARY False Negative Rate	40; 25	—

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.

Eligibility Criteria

Inclusion Criteria

Patients

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03273426). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.