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A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer

NCT04031885 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2021-08-24

Study results available
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Summary

The reason for this study is to compare the efficacy of abemaciclib, in combination with fulvestrant, to that of physician's choice of chemotherapy in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer that has spread to internal organs. Your participation in this trial could last up to 31 months, depending on your cancer type and how you and your tumor respond.

Conditions

Interventions

DRUG

Abemaciclib

Administered orally

DRUG

Fulvestrant

Administered IM

DRUG

Standard Chemotherapy

Standard chemotherapy of physician's choice administered according to product label.

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
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-14
Primary Completion
2020-08-11
Completion
2020-08-11
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT04031885 on ClinicalTrials.gov