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A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer

NCT02107703 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 669

Last updated 2025-10-21

Study results available
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Summary

The main purpose of this study is to compare progression-free survival for women with hormone receptor positive (HR+), human epidermal growth factor receptor (HER2) negative advanced breast cancer receiving either abemaciclib + fulvestrant or fulvestrant alone. Participants will be randomized to abemaciclib or placebo in a 2:1 ratio. The study will last about 9 months for each participant.

For the endocrine naïve cohort, all participants will received abemaciclib + fulvestrant.

Conditions

  • Breast Neoplasms

Interventions

DRUG

Abemaciclib

Administered Orally

DRUG

Fulvestrant

Administered IM

DRUG

Placebo

Administered Orally

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
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-22
Primary Completion
2017-02-14
Completion
2027-12-31

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Italy
  • Japan
  • Mexico
  • Poland
  • Puerto Rico
  • Romania
  • Russia
  • South Korea
  • Spain
  • Switzerland
  • Taiwan

Study Locations

More Related Trials

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 NCT02107703 on ClinicalTrials.gov