A Study of Abemaciclib (LY2835219) With and Without Food in Participants With Metastatic Breast Cancer

Eli Lilly and Company72 enrolled

Overview

The main purpose of this study is to examine the side effects that participants with metastatic breast cancer experience when taking abemaciclib with or without food.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Breast Cancer

Interventions

AbemaciclibDRUG

Administered orally.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Have a diagnosis of HR+, HER2- metastatic breast cancer (mBC). * Have all of the following: * Recurrent, locally advanced, unresectable or mBC with disease progression following anti-estrogen therapy. * Prior treatment with chemotherapy for locally advanced or metastatic disease. * No prior treatment with cyclin-dependent kinases (CDK) 4 and 6 inhibitor. * Have Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1. * Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy. * Have adequate organ function. * Women of child-bearing potential must have a negative pregnancy test. * Are able to swallow tablets/capsules. Exclusion Criteria: * Are currently receiving treatment in a clinical study involving an investigational product. * Have a serious concomitant systemic disorder. * Have symptomatic central nervous system (CNS) malignancy or metastasis. * Have a symptomatic Human Immunodeficiency Virus (HIV) infection or symptomatic activated/reactivated hepatitis A, B, or C. * Have a personal history of syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest. * Have a history of any other cancer. * Had major surgery within 14 days prior to randomization. * Are breastfeeding. * Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively.

Locations (15)

Mater Private Hospital

North Sydney, New South Wales, Australia

St Vincent's Hospital

Sydney, New South Wales, Australia

Ashford Cancer Centre Research

Outcomes

Primary Outcomes

Percentage of Participants With Severe Diarrhea (≥ Grade 3)

Percentage of participants with severe diarrhea (≥ grade 3) during the first 3 cycles. Events were as assessed by the investigator and graded according to Common Terminology Criteria for Adverse Events (CTCAE). Grade 3 was defined as an increase of ≥7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self-care activities of daily living (ADL).