Neoadjuvant Her2-targeted Therapy & Immunotherapy With Pembrolizumab

Status Active, not recruiting

Clinical Trial Summary

Clinical Trial Description

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-K), or neoadjuvant trastuzumab, pembrolizumab and weekly paclitaxel (TH-K) 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. Patients will be randomized to either Arm A: THP (trastuzumab, pertuzumab and weekly paclitaxel), Arm B: THP-K (trastuzumab, pertuzumab, pembrolizumab and weekly paclitaxel) or Arm C: TH-K (trastuzumab, pembrolizumab and weekly paclitaxel). Patients will be stratified according to hormone receptor status and lymph node status. All patients will be treated weekly every three weeks for four cycles (only paclitaxel will be administered weekly) and then undergo breast surgery. Arm A patients will be regarded as the reference group. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03747120
Study type	Interventional
Source	University of Texas Southwestern Medical Center
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	January 25, 2019
Completion date	July 2025

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See also
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Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms