Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02102490 · OUTCOME

Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])

A Study of Abemaciclib (LY2835219) In Participants With Previously Treated Breast Cancer That Has Spread · Source last updated 2020-01-21

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

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)

What was measured

ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.

Analysis population: All enrolled participants who received at least one dose of study drug.

Groups in this outcome

Abemaciclib

200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.

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

Analysis denominator · Participants

GroupSource count
Abemaciclib132

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Abemaciclib19.7Not reported13.327.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        13.3
        upper Limit
        27.5
        value
        19.7
denoms
  1. counts
    1. group Id
      OG000
      value
      132
    units
    Participants
description
ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.
dispersion Type
95% Confidence Interval
groups
  1. description
    200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
    id
    OG000
    title
    Abemaciclib
param Type
NUMBER
population Description
All enrolled participants who received at least one dose of study drug.
reporting Status
POSTED
time Frame
From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
title
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
type
PRIMARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice