NCT03747120

Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab [IIT2018-04-MCARTHUR-NEOHP]

Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab (neoHIP)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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-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. Patients will be randomized to either Arm A: THP (trastuzumab, pertuzumab and weekly paclitaxel), Arm B: THP-pembrolizumab (trastuzumab, pertuzumab, pembrolizumab) and weekly paclitaxel) or Arm C: TH-pembrolizumab (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.

Conditions

• HER2-positive Breast Cancer
• Breast Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel	All subjects will receive Paclitaxel weekly for 12 weeks
DRUG	Trastuzumab	All subjects will receive Trastuzumab every 3 weeks
DRUG	Pertuzumab	Arm A and Arm B subjects will receive Pertuzumab every 3 weeks
DRUG	Pembrolizumab	Arm B and Arm C subjects will receive Pembrolizumab every 3 weeks

Timeline

• Start date: 2019-01-25
• Primary completion: 2024-11-08
• Completion: 2029-12-01
• First posted: 2018-11-20
• Last updated: 2025-06-27
• Results posted: 2025-05-08

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study