At a glance
ClinicalIndex Comparison Record- ✓Age 18-70 years
- ✓Clinical T2-T4d or T1c with axillary lymph node positivity
- ✓Histopathologically confirmed HER2-positive invasive breast cancer
- ✓HER2 positivity by IHC 3+ or IHC 2+ with FISH-confirmed gene amplification
- ✕Stage IV (metastatic) breast cancer
- ✕Bilateral breast cancer
- ✕Prior chemotherapy, endocrine therapy, targeted therapy, or radiotherapy for this disease
- ✕Second primary malignancy except adequately treated skin cancer
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT04547907Phase 3RecruitingUpdate OverdueUpdated 21mo ago · Completion was 18mo agoComparing the Efficacy of Nab-PHP and TCbHP in Neoadjuvant Therapy for HER2-positive Early Breast Cancer, A Multicenter, Randomized, Phase III Clinical Trial
In Brief
A Phase 3 clinical trial evaluating Nab-paclitaxel+ trastuzumab+ patuzumab and Docetaxel+ carboplatin+ trastuzumab + patuzumab for Breast Cancer,HER2-positive. Currently recruiting, targeting 688 participants across 1 site.
Signals
Detailed Summary
The aim of this study is to evaluates the efficacy of weekly nab-paclitaxel monotherapy compared to the standard regimen of docetaxel plus carboplatin, both supplemented with trastuzumab and pertuzumab, as neoadjuvant therapies for HER2-positive breast cancer.
Study Details
Timeline
Interventions
Nab-paclitaxel 125mg/m2 (days 1, 8, 15) + Trastuzumab (initial loading dose of 8 mg/kg, subsequent maintenance dose of 6 mg/kg) + Pertuzumab (initial loading dose of 840mg, subsequent maintenance dose of 420mg), every 21 days constitute a cycle.
Docetaxel 75 mg/m2(day 1) + Carboplatin (AUC=6) (day 1) + Trastuzumab (initial loading dose of 8 mg/kg, subsequent maintenance dose of 6 mg/kg) + Pertuzumab (initial loading dose of 840mg, subsequent maintenance dose of 420mg), every 21 days constitute a cycle.