Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer

Draft scope assessment: unclear. Attached because the study's own record names HR. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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, in the global cohort. Participants who discontinue treatment prior to progression should continue to be scanned until progression. 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).

Overall population in the global cohort

→

primary · POSTED

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.

Overall population in the Global Cohort

→

primary · POSTED

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.

Altered population in the Global Cohort

→

primary · POSTED

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.

Altered population in the Global Cohort

→

primary · POSTED

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, in the global cohort. 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.

Full analysis set in the China cohort

→

primary · POSTED

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.

Full analysis set in the China cohort

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-breast-cancer-femara-ea5f0363
nct id: NCT04305496
trial label: Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer
applicability: unclear
applicability note: Attached because the study's own record names HR. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 4
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT04305496
outcome key
om-0000
source section id
NCT04305496-om-0000
source outcome index
0
endpoint
Progression Free Survival: Overall Population (Months) in the Global Cohort
endpoint definition
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, in the global cohort. Participants who discontinue treatment prior to progression should continue to be scanned until progression. 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).
time origin
Assessed every 8 weeks for the first 18 months and every 12 weeks thereafter, from randomization to radiological progression.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Overall population in the global cohort
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT04305496
outcome key
om-0001
source section id
NCT04305496-om-0001
source outcome index
1
endpoint
Progression Free Survival: Overall Population (Percentage) in the Global Cohort
endpoint definition
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.
time origin
Assessed every 8 weeks for the first 18 months and every 12 weeks thereafter, from randomization to radiological progression.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Overall population in the Global Cohort
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT04305496
outcome key
om-0002
source section id
NCT04305496-om-0002
source outcome index
2
endpoint
Progression Free Survival: Altered Population (Months) in the Global Cohort
endpoint definition
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.
time origin
Assessed every 8 weeks for the first 2 years following objective disease progression or treatment discontinuation and then every 12 weeks.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Altered population in the Global Cohort
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT04305496
outcome key
om-0003
source section id
NCT04305496-om-0003
source outcome index
3
endpoint
Progression Free Survival: Altered Population (Percentage) in the Global Cohort
endpoint definition
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.
time origin
Assessed every 8 weeks for the first 2 years following objective disease progression or treatment discontinuation and then every 12 weeks.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Altered population in the Global Cohort
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT04305496
outcome key
om-0004
source section id
NCT04305496-om-0004
source outcome index
4
endpoint
Progression Free Survival: Overall Population (Months) in the China Cohort
endpoint definition
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, in the global cohort. 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.
time origin
Assessed every 8 weeks for the first 18 months and every 12 weeks thereafter, from randomization to radiological progression.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Full analysis set in the China cohort
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT04305496
outcome key
om-0005
source section id
NCT04305496-om-0005
source outcome index
5
endpoint
Progression Free Survival: Overall Population (Percentage) in the China Cohort
endpoint definition
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.
time origin
Assessed every 8 weeks for the first 18 months and every 12 weeks thereafter, from randomization to radiological progression.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Full analysis set in the China cohort
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT04305496
outcome key
om-0000
arm key
OG000
arm label
Capivasertib + Fulvestrant (Global + China Cohort)
regimen
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.
analyzed count
355
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04305496-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT04305496
outcome key
om-0000
arm key
OG001
arm label
Placebo + Fulvestrant (Global + China Cohort)
regimen
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.
analyzed count
353
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04305496-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT04305496
outcome key
om-0001
arm key
OG000
arm label
Capivasertib + Fulvestrant (Global + China Cohort)
regimen
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.
analyzed count
355
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04305496-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT04305496
outcome key
om-0001
arm key
OG001
arm label
Placebo + Fulvestrant (Global + China Cohort)
regimen
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.
analyzed count
353
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04305496-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT04305496
outcome key
om-0002
arm key
OG000
arm label
Capivasertib + Fulvestrant (Global + China Cohort)
regimen
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.
analyzed count
155
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04305496-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT04305496
outcome key
om-0002
arm key
OG001
arm label
Placebo + Fulvestrant (Global + China Cohort)
regimen
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.
analyzed count
134
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04305496-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT04305496
outcome key
om-0003
arm key
OG000
arm label
Capivasertib + Fulvestrant (Global + China Cohort)
regimen
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.
analyzed count
155
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04305496-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT04305496
outcome key
om-0003
arm key
OG001
arm label
Placebo + Fulvestrant (Global + China Cohort)
regimen
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.
analyzed count
134
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04305496-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT04305496
outcome key
om-0004
arm key
OG000
arm label
Capivasertib + Fulvestrant (Global + China Cohort)
regimen
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.
analyzed count
71
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04305496-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT04305496
outcome key
om-0004
arm key
OG001
arm label
Placebo + Fulvestrant (China Cohort)
regimen
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.
analyzed count
63
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04305496-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT04305496
outcome key
om-0005
arm key
OG000
arm label
Capivasertib + Fulvestrant (Global + China Cohort)
regimen
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.
analyzed count
71
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04305496-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT04305496
outcome key
om-0005
arm key
OG001
arm label
Placebo + Fulvestrant (China Cohort)
regimen
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.
analyzed count
63
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04305496-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT04305496
harm key
EG000
source section id
NCT04305496-ae
event group key
EG000
event group label
Capi (Global Cohort)
serious affected
57
serious at risk
355
other affected
334
other at risk
355
frequency threshold
5
collection period
Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented.
event definition
Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT04305496
harm key
EG001
source section id
NCT04305496-ae
event group key
EG001
event group label
Placebo (Global Cohort)
serious affected
28
serious at risk
350
other affected
255
other at risk
350
frequency threshold
5
collection period
Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented.
event definition
Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT04305496
harm key
EG002
source section id
NCT04305496-ae
event group key
EG002
event group label
Capi (China Cohort)
serious affected
20
serious at risk
71
other affected
67
other at risk
71
frequency threshold
5
collection period
Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented.
event definition
Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT04305496
harm key
EG003
source section id
NCT04305496-ae
event group key
EG003
event group label
Placebo (China Cohort)
serious affected
3
serious at risk
62
other affected
52
other at risk
62
frequency threshold
5
collection period
Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented.
event definition
Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice