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NCT02102490 · OUTCOME

Percentage of Participants With CR, PR or SD (Disease Control Rate [DCR])

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

Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. 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 LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, 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
Abemaciclib67.4Not reported58.775.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        58.7
        upper Limit
        75.3
        value
        67.4
denoms
  1. counts
    1. group Id
      OG000
      value
      132
    units
    Participants
description
Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. 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 LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, 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 CR, PR or SD (Disease Control Rate [DCR])
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice