NCT00099437 · STUDY IN CONTEXT

Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endo

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

Median time (in months) from randomisation until objective disease progression or death (in the absence of objective progression).

Source null

→

secondary · POSTED

Using the RECIST scan data, an objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR) which is subsequently confirmed as per RECIST. ORR is defined as the percentage of patients with OR.

All patients with measurable disease at baseline.

→

secondary · POSTED

A Clinical Benefit (CB) responder is defined as a patient having a best overall response of CR, PR or SD (stable disease) \>=24 weeks. The Clinical Benefit Rate is the percentage of patients with CB.

Source null

→

secondary · POSTED

Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR) or confirmed partial response (PR)

Source null

→

secondary · POSTED

Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) \>=24 weeks

Source null

→

secondary · POSTED

Median time (in months) from randomisation until death (from any cause) (analysis at 50% deaths )

All patients with measurable disease at baseline.

→

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

FACT · Change From Randomisation in Trial Outcome Index (TOI) Over the Course of the Study

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-breast-cancer
nct id: NCT00099437
qol key: qol-0006
source section id: NCT00099437-om-0006
source outcome index: 6
instrument: FACT
instrument basis: matched 'fact-b' in the study's own wording
scale title: Change From Randomisation in Trial Outcome Index (TOI) Over the Course of the Study
measure definition: Mean (and standard deviation) change from randomisation until treatment discontinuation in TOI (defined as the first visit response of 'worsened' which is a decrease in TOI from baseline of 5 points or more) using the Kaplan-Meier method. If a subject has not shown a reduction of 5 points or more at the time of analysis then the observation will be right censored using the last QOL assessment date. Trial Outcome Index (TOI) is derived from the FACT-B questionnaire (Cella et al, 1993) by adding together the scores from the following 3 subscales; Physical well-being (PWB), Functional well-being (FWB) and Breast cancer subscale (BCS). The TOI score range is 0-92 with the higher scores representing the more favourable outcomes. Data were collected from a subgroup of patients.
time frame: TOI questionnaires were completed every 4 weeks from randomisation until week 24 and then again at treatment discontinuation, for study duration (48 months)
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: Source null
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-breast-cancer
nct id: NCT00099437
trial label: Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endo
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: 1

outcomes

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00099437
outcome key
om-0000
source section id
NCT00099437-om-0000
source outcome index
0
endpoint
Time to Progression (TTP)
endpoint definition
Median time (in months) from randomisation until objective disease progression or death (in the absence of objective progression).
time origin
RECIST(Response Evaluation Criteria in Solid Tumors ) tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
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
NCT00099437
outcome key
om-0001
source section id
NCT00099437-om-0001
source outcome index
1
endpoint
Objective Response Rate (ORR)
endpoint definition
Using the RECIST scan data, an objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR) which is subsequently confirmed as per RECIST. ORR is defined as the percentage of patients with OR.
time origin
RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All patients with measurable disease at baseline.
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
NCT00099437
outcome key
om-0002
source section id
NCT00099437-om-0002
source outcome index
2
endpoint
Clinical Benefit Rate (CBR)
endpoint definition
A Clinical Benefit (CB) responder is defined as a patient having a best overall response of CR, PR or SD (stable disease) \>=24 weeks. The Clinical Benefit Rate is the percentage of patients with CB.
time origin
Clinical Benefit from the sequence of RECIST scan data for study duration (48 months) . RECIST (Response Evaluation Criteria in Solid Tumours) scans were performed every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
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
NCT00099437
outcome key
om-0003
source section id
NCT00099437-om-0003
source outcome index
3
endpoint
Duration of Response (DoR)
endpoint definition
Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR) or confirmed partial response (PR)
time origin
RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
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
NCT00099437
outcome key
om-0004
source section id
NCT00099437-om-0004
source outcome index
4
endpoint
Duration of Clinical Benefit (DoCB)
endpoint definition
Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) \>=24 weeks
time origin
RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
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
NCT00099437
outcome key
om-0005
source section id
NCT00099437-om-0005
source outcome index
5
endpoint
Overall Survival (OS)
endpoint definition
Median time (in months) from randomisation until death (from any cause) (analysis at 50% deaths )
time origin
Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring for study duration (48 months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All patients with measurable disease at baseline.
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
NCT00099437
outcome key
om-0000
arm key
OG000
arm label
Fulvestrant 250 mg
regimen
Fulvestrant 250 mg Intramuscular Injection every 28 days
analyzed count
374
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00099437-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00099437
outcome key
om-0000
arm key
OG001
arm label
Fulvestrant 500 mg
regimen
Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
analyzed count
362
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00099437-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00099437
outcome key
om-0001
arm key
OG000
arm label
Fulvestrant 250 mg
regimen
Fulvestrant 250 mg Intramuscular Injection every 28 days
analyzed count
261
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00099437-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00099437
outcome key
om-0001
arm key
OG001
arm label
Fulvestrant 500 mg
regimen
Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
analyzed count
240
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00099437-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00099437
outcome key
om-0002
arm key
OG000
arm label
Fulvestrant 250 mg
regimen
Fulvestrant 250 mg Intramuscular Injection every 28 days
analyzed count
374
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00099437-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00099437
outcome key
om-0002
arm key
OG001
arm label
Fulvestrant 500 mg
regimen
Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
analyzed count
362
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00099437-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00099437
outcome key
om-0003
arm key
OG000
arm label
Fulvestrant 250 mg
regimen
Fulvestrant 250 mg Intramuscular Injection every 28 days
analyzed count
38
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00099437-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00099437
outcome key
om-0003
arm key
OG001
arm label
Fulvestrant 500 mg
regimen
Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
analyzed count
33
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00099437-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00099437
outcome key
om-0004
arm key
OG000
arm label
Fulvestrant 250 mg
regimen
Fulvestrant 250 mg Intramuscular Injection every 28 days
analyzed count
148
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00099437-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00099437
outcome key
om-0004
arm key
OG001
arm label
Fulvestrant 500 mg
regimen
Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
analyzed count
165
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00099437-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00099437
outcome key
om-0005
arm key
OG000
arm label
Fulvestrant 250 mg
regimen
Fulvestrant 250 mg Intramuscular Injection every 28 days
analyzed count
374
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00099437-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00099437
outcome key
om-0005
arm key
OG001
arm label
Fulvestrant 500 mg
regimen
Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
analyzed count
362
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00099437-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00099437
harm key
EG000
source section id
NCT00099437-ae
event group key
EG000
event group label
Fulvestrant 250 mg
serious affected
27
serious at risk
374
other affected
235
other at risk
374
frequency threshold
5
collection period
SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009
event definition
1 participant was randomised to fulvestrant 500 mg but did not receive any treatment. AEs have been collected up to primary data cut off. SAEs have been collected up to follow-up phase data cut-off.
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
NCT00099437
harm key
EG001
source section id
NCT00099437-ae
event group key
EG001
event group label
Fulvestrant 500 mg
serious affected
35
serious at risk
361
other affected
241
other at risk
361
frequency threshold
5
collection period
SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009
event definition
1 participant was randomised to fulvestrant 500 mg but did not receive any treatment. AEs have been collected up to primary data cut off. SAEs have been collected up to follow-up phase data cut-off.
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

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00099437
qol key
qol-0006
source section id
NCT00099437-om-0006
source outcome index
6
instrument
FACT
instrument basis
matched 'fact-b' in the study's own wording
scale title
Change From Randomisation in Trial Outcome Index (TOI) Over the Course of the Study
measure definition
Mean (and standard deviation) change from randomisation until treatment discontinuation in TOI (defined as the first visit response of 'worsened' which is a decrease in TOI from baseline of 5 points or more) using the Kaplan-Meier method. If a subject has not shown a reduction of 5 points or more at the time of analysis then the observation will be right censored using the last QOL assessment date. Trial Outcome Index (TOI) is derived from the FACT-B questionnaire (Cella et al, 1993) by adding together the scores from the following 3 subscales; Physical well-being (PWB), Functional well-being (FWB) and Breast cancer subscale (BCS). The TOI score range is 0-92 with the higher scores representing the more favourable outcomes. Data were collected from a subgroup of patients.
time frame
TOI questionnaires were completed every 4 weeks from randomisation until week 24 and then again at treatment discontinuation, for study duration (48 months)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

setting source links

Preserved source evidence · Not medical advice