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Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer

NCT05169567 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 368

Last updated 2026-01-16

Study results available
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Summary

This study will evaluate the effect of adding abemaciclib to fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that progressed or recurred after previous treatment with a type of drug known as a CDK4/6 inhibitor and endocrine therapy. Participation could last up to 5 years, depending on how you and your tumor respond.

Conditions

  • Breast Neoplasm
  • Neoplasm Metastasis

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
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-11
Primary Completion
2024-02-08
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Czechia
  • Denmark
  • France
  • Greece
  • Hungary
  • Israel
  • Italy
  • Mexico
  • Poland
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Turkey (Türkiye)

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 NCT05169567 on ClinicalTrials.gov