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A Study of Abemaciclib in Indian Women With Advanced Breast Cancer

NCT04707196 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-11-24

Study results available
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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

DRUG

Abemaciclib

Administered orally

DRUG

Nonsteroidal Aromatase Inhibitor (NSAI)

Letrozole or anastrozole administered orally (physician choice)

DRUG

Fulvestrant

Administered intramuscularly

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-22
Primary Completion
2023-01-09
Completion
2023-01-09
FDA Drug
Yes

Countries

  • India

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04707196 on ClinicalTrials.gov