NCT04305496 · OUTCOME

Progression Free Survival: Overall Population (Percentage) in the China 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: Full analysis set in the China 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 (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.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)	71
Placebo + Fulvestrant (China Cohort)	63

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)	53.9	Not reported	41.3	65.0	Not reported
Placebo + Fulvestrant (China Cohort)	24.5	Not reported	14.6	35.8	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)	40.9	Not reported	28.8	52.5	Not reported
Placebo + Fulvestrant (China Cohort)	24.5	Not reported	14.6	35.8	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)	29.6	Not reported	18.6	41.4	Not reported
Placebo + Fulvestrant (China Cohort)	19.1	Not reported	10.3	29.9	Not reported

Source statistical analyses

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

ci Lower Limit
0.34
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.76
group Ids
OG000
non Inferiority Type
SUPERIORITY
p Value
<0.001
param Type
Hazard Ratio (HR)
param Value
0.51
statistical Method
Stratified log rank test

Complete source fields

analyses

ci Lower Limit
0.34
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.76
group Ids
OG000
non Inferiority Type
SUPERIORITY
p Value
<0.001
param Type
Hazard Ratio (HR)
param Value
0.51
statistical Method
Stratified log rank test

classes

categories
measurements
group Id
OG000
lower Limit
41.3
upper Limit
65.0
value
53.9
group Id
OG001
lower Limit
14.6
upper Limit
35.8
value
24.5
title
PFS rate at 6 months
categories
measurements
group Id
OG000
lower Limit
28.8
upper Limit
52.5
value
40.9
group Id
OG001
lower Limit
14.6
upper Limit
35.8
value
24.5
title
PFS rate at 9 months
categories
measurements
group Id
OG000
lower Limit
18.6
upper Limit
41.4
value
29.6
group Id
OG001
lower Limit
10.3
upper Limit
29.9
value
19.1
title
PFS rate at 12 months

denoms

counts
group Id
OG000
value
71
group Id
OG001
value
63
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.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 (China Cohort)

param Type

NUMBER

population Description

Full analysis set in the China 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 China Cohort

type

PRIMARY

unit Of Measure

Percentage of participants

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

Preserved source evidence · Not medical advice