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NCT03125902 · OUTCOME

Progression Free Survival by PD-L1 Status, Intent to Treat Population

A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC) · Source last updated 2024-03-26

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From Day 1 up to primary completion date (approximately 26 months)

Analysis population: ITT population: all randomized participants, whether or not the assigned study treatment was received

Groups in this outcome

Placebo and Paclitaxel

Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.

Atezolizumab and Paclitaxel

Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Placebo and Paclitaxel220
Atezolizumab and Paclitaxel431

Reported measurements

PD-L1 IC0

Analysis denominator · Participants

GroupSource count
Placebo and Paclitaxel119
Atezolizumab and Paclitaxel240
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo and Paclitaxel5.49Not reported3.846.51Not reported
Atezolizumab and Paclitaxel5.45Not reported4.606.51Not reported
PD-L1 IC1/2/3

Analysis denominator · Participants

GroupSource count
Placebo and Paclitaxel101
Atezolizumab and Paclitaxel191
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo and Paclitaxel5.72Not reported5.397.20Not reported
Atezolizumab and Paclitaxel5.95Not reported5.627.43Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.84
        upper Limit
        6.51
        value
        5.49
      2. group Id
        OG001
        lower Limit
        4.60
        upper Limit
        6.51
        value
        5.45
    denoms
    1. counts
      1. group Id
        OG000
        value
        119
      2. group Id
        OG001
        value
        240
      units
      Participants
    title
    PD-L1 IC0
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.39
        upper Limit
        7.20
        value
        5.72
      2. group Id
        OG001
        lower Limit
        5.62
        upper Limit
        7.43
        value
        5.95
    denoms
    1. counts
      1. group Id
        OG000
        value
        101
      2. group Id
        OG001
        value
        191
      units
      Participants
    title
    PD-L1 IC1/2/3
denoms
  1. counts
    1. group Id
      OG000
      value
      220
    2. group Id
      OG001
      value
      431
    units
    Participants
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
    id
    OG000
    title
    Placebo and Paclitaxel
  2. description
    Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
    id
    OG001
    title
    Atezolizumab and Paclitaxel
param Type
MEDIAN
population Description
ITT population: all randomized participants, whether or not the assigned study treatment was received
reporting Status
POSTED
time Frame
From Day 1 up to primary completion date (approximately 26 months)
title
Progression Free Survival by PD-L1 Status, Intent to Treat Population
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice