At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
monarcHER: A Phase 2, Randomized, Multicenter, 3-Arm, Open-Label Study to Compare the Efficacy of Abemaciclib Plus Trastuzumab With or Without Fulvestrant to Standard-of-Care Chemotherapy of Physician's Choice Plus Trastuzumab in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer
In Brief
A Phase 2 clinical trial evaluating Abemaciclib, Trastuzumab, and 2 other interventions for Hormone Receptor Positive Breast Cancer and HER-2 Positive Breast Cancer. Completed, enrolled 237 participants across 93 sites in 14 countries.
Detailed Summary
The purpose of this study is to evaluate the effectiveness of abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus physicians choice standard of care chemotherapy in women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 positive (HER2+) locally advanced or metastatic breast cancer after prior exposure to at least two HER2-directed therapies for advanced disease.
Study Details
Timeline
Interventions
Administered Orally
Administered IV
Administered IM
Standard-of-care single-agent chemotherapy of physician's choice administered according to product label