NCT04707196

A Study of Abemaciclib in Indian Women With Advanced Breast Cancer

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Neoplasms
• Neoplasm Metastasis

Interventions

Type	Name	Description
DRUG	Abemaciclib	Administered orally
DRUG	Nonsteroidal Aromatase Inhibitor (NSAI)	Letrozole or anastrozole administered orally (physician choice)
DRUG	Fulvestrant	Administered intramuscularly

Timeline

• Start date: 2021-02-22
• Primary completion: 2023-01-09
• Completion: 2023-01-09
• First posted: 2021-01-13
• Last updated: 2023-11-24
• Results posted: 2023-11-21

Locations

15 sites across 1 country: India

Regulatory

• FDA-regulated drug study