At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed HER2-positive invasive breast cancer by ASCO/CAP guidelines
- ✓Previously untreated, non-metastatic disease with cT2-4N0 or cT1-4N1-3 nodal stage
- ✓Age ≥18 years
- ✓ECOG performance status 0–1
- ✕Prior systemic anti-cancer therapy within 4 weeks
- ✕Prior anti-PD-1, anti-PD-L1, anti-PD-L2, or other immune checkpoint inhibitor therapy
- ✕Active autoimmune disease requiring systemic treatment within past 2 years
- ✕Prior radiotherapy within 2 weeks
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab (neoHIP)
In Brief
A Phase 2 clinical trial evaluating Paclitaxel, Trastuzumab, and 2 other interventions for HER2-positive Breast Cancer and Breast Cancer. Active but no longer recruiting, targeting 138 participants across 5 sites.
Detailed Summary
A phase 2 open-label, randomized, multi-center trial to evaluate the efficacy and safety of neoadjuvant trastuzumab, pertuzumab and weekly paclitaxel (THP) as compared to neoadjuvant trastuzumab, pertuzumab, pembrolizumab and weekly paclitaxel (THP-pembrolizumab), or neoadjuvant trastuzumab, pembrolizumab and weekly paclitaxel (TH-pembrolizumab ) in chemo naive patients with invasive human epidermal growth factor receptor 2 (HER2) positive breast cancer whose primary tumors are \> 2 cm and/or clinically lymph node positive. Treatment will be followed by standard of care breast surgery and physician's choice adjuvant therapy per standard of care.
Study Details
Timeline
Interventions
All subjects will receive Paclitaxel weekly for 12 weeks
All subjects will receive Trastuzumab every 3 weeks
Arm A and Arm B subjects will receive Pertuzumab every 3 weeks
Arm B and Arm C subjects will receive Pembrolizumab every 3 weeks