NCT00256698 · STUDY IN CONTEXT

Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. 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

RECIST (Response Evaluation Criteria in Solid Tumours) assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009. TTP, time in months to worsen 'progression' according to RECIST criteria. (RECIST is a set of published rules that define when cancer patients improve "respond", stay the same "stable"or worsen "progression" during treatments.

Source null

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secondary · POSTED

No. of patients who were objective responders over the no. of patients evaluable for response x100. An objective responder = a patient whose best response is either CR (disappearance of all lesions) or PR (\>= 30% shrinkage in the sum of the longest diamemeters of the measurable lesions + no new lesions + no progression of non-measurable lesions)

Source null

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secondary · POSTED

No. of patients who were clinical benefit responders over the no. of randomised patients x100. A clinical benefit responder = a patient whose best response is CR, PR or SD\>=24 weeks (where a best response of SD = no new lesions and for existing lesions; neither suffient shrinkage to count as PR nor sufficient growth to count as progression)

Source null

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secondary · POSTED

Median time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who are objective responders

Source null

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secondary · POSTED

Median time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who are clinical benefit responders

Source null

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secondary · POSTED

Time from randomisation until the date of discontinuation of randomised treatment for any reason

Source null

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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
nct id: NCT00256698
trial label: Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
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: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00256698
outcome key
om-0000
source section id
NCT00256698-om-0000
source outcome index
0
endpoint
Time to Progression (TTP)
endpoint definition
RECIST (Response Evaluation Criteria in Solid Tumours) assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009. TTP, time in months to worsen 'progression' according to RECIST criteria. (RECIST is a set of published rules that define when cancer patients improve "respond", stay the same "stable"or worsen "progression" during treatments.
time origin
RECIST assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population 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
nct id
NCT00256698
outcome key
om-0001
source section id
NCT00256698-om-0001
source outcome index
1
endpoint
Percentage of Evaluable Participants With Objective Response Rate (ORR)
endpoint definition
No. of patients who were objective responders over the no. of patients evaluable for response x100. An objective responder = a patient whose best response is either CR (disappearance of all lesions) or PR (\>= 30% shrinkage in the sum of the longest diamemeters of the measurable lesions + no new lesions + no progression of non-measurable lesions)
time origin
RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population 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
nct id
NCT00256698
outcome key
om-0002
source section id
NCT00256698-om-0002
source outcome index
2
endpoint
Percentage of Clinical Benefit Rate (CBR) Responders
endpoint definition
No. of patients who were clinical benefit responders over the no. of randomised patients x100. A clinical benefit responder = a patient whose best response is CR, PR or SD\>=24 weeks (where a best response of SD = no new lesions and for existing lesions; neither suffient shrinkage to count as PR nor sufficient growth to count as progression)
time origin
RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population 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
nct id
NCT00256698
outcome key
om-0003
source section id
NCT00256698-om-0003
source outcome index
3
endpoint
Duration of Response (DoR)
endpoint definition
Median time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who are objective responders
time origin
RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population 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
nct id
NCT00256698
outcome key
om-0004
source section id
NCT00256698-om-0004
source outcome index
4
endpoint
Duration of Clinical Benefit (DoCB)
endpoint definition
Median time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who are clinical benefit responders
time origin
RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population 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
nct id
NCT00256698
outcome key
om-0005
source section id
NCT00256698-om-0005
source outcome index
5
endpoint
Time to Treatment Failure (TTF)
endpoint definition
Time from randomisation until the date of discontinuation of randomised treatment for any reason
time origin
From randomisation until data cut-off on 30th April 2009
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
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
nct id
NCT00256698
outcome key
om-0000
arm key
OG000
arm label
Fulvestrant + Anastrozole
regimen
Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
analyzed count
258
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00256698-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00256698
outcome key
om-0000
arm key
OG001
arm label
Anastrozole
regimen
Anastrozole 1 mg
analyzed count
256
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00256698-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00256698
outcome key
om-0001
arm key
OG000
arm label
Fulvestrant + Anastrozole
regimen
Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
analyzed count
129
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00256698-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00256698
outcome key
om-0001
arm key
OG001
arm label
Anastrozole
regimen
Anastrozole 1 mg
analyzed count
113
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00256698-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00256698
outcome key
om-0002
arm key
OG000
arm label
Fulvestrant + Anastrozole
regimen
Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
analyzed count
258
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00256698-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00256698
outcome key
om-0002
arm key
OG001
arm label
Anastrozole
regimen
Anastrozole 1 mg
analyzed count
256
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00256698-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00256698
outcome key
om-0003
arm key
OG000
arm label
Fulvestrant + Anastrozole
regimen
Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
analyzed count
129
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00256698-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00256698
outcome key
om-0003
arm key
OG001
arm label
Anastrozole
regimen
Anastrozole 1 mg
analyzed count
113
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00256698-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00256698
outcome key
om-0004
arm key
OG000
arm label
Fulvestrant + Anastrozole
regimen
Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
analyzed count
258
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00256698-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00256698
outcome key
om-0004
arm key
OG001
arm label
Anastrozole
regimen
Anastrozole 1 mg
analyzed count
256
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00256698-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00256698
outcome key
om-0005
arm key
OG000
arm label
Fulvestrant + Anastrozole
regimen
Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
analyzed count
258
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00256698-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00256698
outcome key
om-0005
arm key
OG001
arm label
Anastrozole
regimen
Anastrozole 1 mg
analyzed count
256
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00256698-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00256698
harm key
EG000
source section id
NCT00256698-ae
event group key
EG000
event group label
Fulvestrant + Anastrozole
serious affected
40
serious at risk
256
other affected
161
other at risk
256
frequency threshold
5
collection period
Source null
event definition
Source null
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
nct id
NCT00256698
harm key
EG001
source section id
NCT00256698-ae
event group key
EG001
event group label
Anastrozole
serious affected
45
serious at risk
254
other affected
178
other at risk
254
frequency threshold
5
collection period
Source null
event definition
Source null
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