NCT04305496 · OUTCOME

Progression Free Survival: Altered 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 2 years following objective disease progression or treatment discontinuation and then every 12 weeks.

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. Kaplan-Meier estimate was used.

Analysis population: Altered 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

Group	Source count
Capivasertib + Fulvestrant (Global + China Cohort)	155
Placebo + Fulvestrant (Global + China Cohort)	134

Reported measurements

PFS rate at 6 months

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Capivasertib + Fulvestrant (Global + China Cohort)	53.4	Not reported	45.1	60.9	Not reported
Placebo + Fulvestrant (Global + China Cohort)	29.6	Not reported	21.9	37.7	Not reported

PFS rate at 9 months

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Capivasertib + Fulvestrant (Global + China Cohort)	42.0	Not reported	34.0	49.7	Not reported
Placebo + Fulvestrant (Global + China Cohort)	21.6	Not reported	14.9	29.1	Not reported

PFS rate at 12 months

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Capivasertib + Fulvestrant (Global + China Cohort)	28.2	Not reported	21.2	35.6	Not reported
Placebo + Fulvestrant (Global + China Cohort)	15.8	Not reported	10.0	22.7	Not reported

Source statistical analyses

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

ci Lower Limit
0.38
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.65
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.001
param Type
Hazard Ratio (HR)
param Value
0.50
statistical Method
Stratified log-rank test

Complete source fields

analyses

ci Lower Limit
0.38
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.65
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.001
param Type
Hazard Ratio (HR)
param Value
0.50
statistical Method
Stratified log-rank test

classes

categories
measurements
group Id
OG000
lower Limit
45.1
upper Limit
60.9
value
53.4
group Id
OG001
lower Limit
21.9
upper Limit
37.7
value
29.6
title
PFS rate at 6 months
categories
measurements
group Id
OG000
lower Limit
34.0
upper Limit
49.7
value
42.0
group Id
OG001
lower Limit
14.9
upper Limit
29.1
value
21.6
title
PFS rate at 9 months
categories
measurements
group Id
OG000
lower Limit
21.2
upper Limit
35.6
value
28.2
group Id
OG001
lower Limit
10.0
upper Limit
22.7
value
15.8
title
PFS rate at 12 months

denoms

counts
group Id
OG000
value
155
group Id
OG001
value
134
units
Participants

description

dispersion Type

95% Confidence Interval

groups

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)
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

Altered population in the Global Cohort

reporting Status

POSTED

time Frame

Assessed every 8 weeks for the first 2 years following objective disease progression or treatment discontinuation and then every 12 weeks.

title

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

type

PRIMARY

unit Of Measure

Percentage of participants

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Preserved source evidence · Not medical advice