N/A
Completed N=40
Prediction of pCR by Preoperative Biopsy in Breast Cancer With cCR After Neoadjuvant Chemotherapy.
Breast Neoplasm
Source: ClinicalTrials.gov NCT03273426 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcomePrimary: Negative Predictive Value — 88.2; 85.7; 87.1 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Negative Predictive Value |
88.2; 85.7; 87.1 | — |
| SECONDARY False Negative Rate |
40; 25 | — |
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
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. Informational only — not medical advice.