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

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.

Trial Details

NCT ID
NCT04817540
Phase
PHASE2
Sponsor
Gangnam Severance Hospital
Status
RECRUITING
Cancer Type
HER2 Negative Breast Cancer
Interventions
  • Herzuma
Locations (sample)
  • Seoul, South Korea|37.566,126.9784

Key Eligibility Criteria

  • Pathologically and cytologically documented unsectable/metastatic breast cancer that :
  • A. has confirmed HER2 negative expression regardless hormone receptor status
  • definition of HER2 negative breast cancer i) HER2 IHC 1+ without ISH or ii) HER2 IHC 2+ and ISH negative (average HER2 gene copy number \<4 signals…
  • No prior treatment of stage II-III breast cancer

For full eligibility, visit ClinicalTrials.gov.

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