NCT04817540

Phase II Trial of Anti-HER2 Treatment in HER2-enriched Early Breast Cancer Identified by PAM50 (HER2E-PAM, PAMILIA Study)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (estimated)
• Sponsor: Gangnam Severance Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

In this study, we prospectively analyzed molecular subtyping through the PAM 50 test in HER2-negative (IHC1+ or 2+ (FISH/SISH-)) breast cancer patients. A phase 2 single arm study was designed to determine whether the addition of HER2-targeted treatment with treatment increases the pathologic remission rate.

Conditions

• HER2 Enriched Subtype Breast Cancer, Herzuma, PAM50 Study

Interventions

Type	Name	Description
DRUG	Herzuma	8mg/kg IVF loading dose at first cycle -\> 6mg/kg IVF at 2,3,4th cycle of each 21 day cycle

Timeline

• Start date: 2021-09-01
• Primary completion: 2024-03-30
• Completion: 2027-03-30
• First posted: 2021-03-26
• Last updated: 2023-10-11

Locations

1 site across 1 country: South Korea