NCT03155997 · OUTCOME

Pharmacokinetics (PK): Minimum Steady State Concentration (Cmin,ss) of Abemaciclib

Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer · Source last updated 2026-04-24

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: GEOMETRIC_MEAN
Unit: Nanograms per milliliter (ng/mL)
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Day 1 (2 hours post-dose), Days 30, 60, 90 post-dose

What was measured

Analysis population: All randomized participants who received at least one dose of Abemaciclib and had evaluable PK data.

Groups in this outcome

150 mg Abemaciclib + Endocrine Therapy

Participants received Abemaciclib orally at 150 milligrams (mg) twice daily with at least 6 hours between doses for up to 2 years or until evidence of disease recurrence or other discontinuation criteria were met, whichever occurs first. Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
150 mg Abemaciclib + Endocrine Therapy	483

Reported measurements

Source class 1

Values in Nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
150 mg Abemaciclib + Endocrine Therapy	143	110	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
110
value
143

denoms

counts
group Id
OG000
value
483
units
Participants

description

Pharmacokinetics (PK): Minimum Steady State Concentration (Cmin,ss) of Abemaciclib

dispersion Type

Geometric Coefficient of Variation

groups

description
Participants received Abemaciclib orally at 150 milligrams (mg) twice daily with at least 6 hours between doses for up to 2 years or until evidence of disease recurrence or other discontinuation criteria were met, whichever occurs first. Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.
id
OG000
title
150 mg Abemaciclib + Endocrine Therapy

param Type

GEOMETRIC_MEAN

population Description

All randomized participants who received at least one dose of Abemaciclib and had evaluable PK data.

reporting Status

POSTED

time Frame

Day 1 (2 hours post-dose), Days 30, 60, 90 post-dose

title

Pharmacokinetics (PK): Minimum Steady State Concentration (Cmin,ss) of Abemaciclib

type

SECONDARY

unit Of Measure

Nanograms per milliliter (ng/mL)

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice