Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04305496 · OUTCOME

Progression Free Survival: Overall Population (Percentage) in the Global Cohort

Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer · Source last updated 2026-04-30

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
Assessed every 8 weeks for the first 18 months and every 12 weeks thereafter, from randomization to radiological progression.

What was measured

Progression free survival (PFS), defined as the time from randomization until progression per RECIST v1.1, as assessed by the investigator at the local site, or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as at least a 20% increase in the sum of the longest diameter of target lesions (short axis diameter used for lymph nodes), or clinically significant increase in a non-target lesion, or the appearance of a new lesion(s). Participants who discontinue treatment prior to progression should continue to be scanned until progression. Kaplan-Meier estimate was used.

Analysis population: Overall population in the Global Cohort

Groups in this outcome

Capivasertib + Fulvestrant (Global + China Cohort)

Capivasertib: 400 mg twice daily (2 tablets of 200 mg taken orally twice daily; total daily dose 800 mg) given on an intermittent weekly dosing schedule (4 days on/3 days off). Fulvestrant: 500 mg (2 intramuscular injections of 250 mg/5 mL solution) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter.

Placebo + Fulvestrant (Global + China Cohort)

Placebo: Placebo tablets matching capivasertib. 400 mg twice daily (2 tablets of 200 mg taken orally twice daily; total daily dose 800 mg) given on an intermittent weekly dosing schedule (4 days on/3 days off). Fulvestrant: 500 mg (2 intramuscular injections of 250 mg/5 mL solution) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter.

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

Analysis denominator · Participants

GroupSource count
Capivasertib + Fulvestrant (Global + China Cohort)355
Placebo + Fulvestrant (Global + China Cohort)353

Reported measurements

PFS rate at 6 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Capivasertib + Fulvestrant (Global + China Cohort)51.8Not reported46.457.0Not reported
Placebo + Fulvestrant (Global + China Cohort)32.0Not reported27.037.0Not reported
PFS rate at 9 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Capivasertib + Fulvestrant (Global + China Cohort)40.9Not reported35.646.1Not reported
Placebo + Fulvestrant (Global + China Cohort)24.4Not reported19.929.1Not reported
PFS rate at 12 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Capivasertib + Fulvestrant (Global + China Cohort)28.5Not reported23.733.5Not reported
Placebo + Fulvestrant (Global + China Cohort)18.4Not reported14.422.8Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.51
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.71
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    param Type
    Hazard Ratio (HR)
    param Value
    0.60
    statistical Method
    Stratified log rank test
Complete source fields
analyses
  1. ci Lower Limit
    0.51
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.71
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    param Type
    Hazard Ratio (HR)
    param Value
    0.60
    statistical Method
    Stratified log rank test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        46.4
        upper Limit
        57.0
        value
        51.8
      2. group Id
        OG001
        lower Limit
        27.0
        upper Limit
        37.0
        value
        32.0
    title
    PFS rate at 6 months
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        35.6
        upper Limit
        46.1
        value
        40.9
      2. group Id
        OG001
        lower Limit
        19.9
        upper Limit
        29.1
        value
        24.4
    title
    PFS rate at 9 months
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        23.7
        upper Limit
        33.5
        value
        28.5
      2. group Id
        OG001
        lower Limit
        14.4
        upper Limit
        22.8
        value
        18.4
    title
    PFS rate at 12 months
denoms
  1. counts
    1. group Id
      OG000
      value
      355
    2. group Id
      OG001
      value
      353
    units
    Participants
description
Progression free survival (PFS), defined as the time from randomization until progression per RECIST v1.1, as assessed by the investigator at the local site, or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as at least a 20% increase in the sum of the longest diameter of target lesions (short axis diameter used for lymph nodes), or clinically significant increase in a non-target lesion, or the appearance of a new lesion(s). Participants who discontinue treatment prior to progression should continue to be scanned until progression. Kaplan-Meier estimate was used.
dispersion Type
95% Confidence Interval
groups
  1. description
    Capivasertib: 400 mg twice daily (2 tablets of 200 mg taken orally twice daily; total daily dose 800 mg) given on an intermittent weekly dosing schedule (4 days on/3 days off). Fulvestrant: 500 mg (2 intramuscular injections of 250 mg/5 mL solution) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter.
    id
    OG000
    title
    Capivasertib + Fulvestrant (Global + China Cohort)
  2. description
    Placebo: Placebo tablets matching capivasertib. 400 mg twice daily (2 tablets of 200 mg taken orally twice daily; total daily dose 800 mg) given on an intermittent weekly dosing schedule (4 days on/3 days off). Fulvestrant: 500 mg (2 intramuscular injections of 250 mg/5 mL solution) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter.
    id
    OG001
    title
    Placebo + Fulvestrant (Global + China Cohort)
param Type
NUMBER
population Description
Overall population in the Global Cohort
reporting Status
POSTED
time Frame
Assessed every 8 weeks for the first 18 months and every 12 weeks thereafter, from randomization to radiological progression.
title
Progression Free Survival: Overall Population (Percentage) in the Global Cohort
type
PRIMARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice