At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single-Arm, Phase 4 Study of Abemaciclib, a CDK4 and CDK6 Inhibitor, in Combination With Endocrine Therapy (Anastrozole/Letrozole or Fulvestrant) in Participants With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Locally Advanced and/or Metastatic Breast Cancer in India
In Brief
A Phase 4 clinical trial evaluating Abemaciclib, Nonsteroidal Aromatase Inhibitor (NSAI), and 1 other intervention for Breast Neoplasms and Neoplasm Metastasis. Completed, enrolled 200 participants across 15 sites.
Detailed Summary
The main purpose of this study is to learn more about the safety and tolerability of abemaciclib when given in combination with hormone therapy in Indian women with advanced breast cancer. Participants must have hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer and must live in India. For each participant, the study could last up to eight months and may include up to eight visits to the study center.
Study Details
Timeline
Interventions
Administered orally
Letrozole or anastrozole administered orally (physician choice)
Administered intramuscularly