S0226 Anastrozole With or Without Fulvestrant as First-Line Therapy in Postmenopausal Women With Metastatic Breast Cancer

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. 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 is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician. Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration. From date of randomization to time of first documentation of progression, symptomatic deterioration or death due to any cause. Patients last known to be alive and progression free are considered at last date of contact.

Source null

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secondary · POSTED

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable, Does not qualify for CR, PR, Progression or Symptomatic Deterioration. Clinical Benefit = CR + PR + Stable \>= 24 weeks

Source null

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secondary · POSTED

From date of randomization to date of death due to any cause. Patients last known to be alive are censored at last date of contact.

Source null

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secondary · POSTED

Adverse Events (AEs) are reported by CTCAE version 3.0 terminology. For each patient, worst grade of each event type is reported. Grade3 (Severe), Grade4 (Life-threatening), Grade 5 (Fatal)

Eligible patients who had received the protocol treatments were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.

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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-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id: NCT00075764
trial label: S0226 Anastrozole With or Without Fulvestrant as First-Line Therapy in Postmenopausal Women With Metastatic Breast Cancer
applicability: unclear
applicability note: Attached because the study's own record describes metastatic disease. 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: 4
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT00075764
outcome key
om-0000
source section id
NCT00075764-om-0000
source outcome index
0
endpoint
Time to Tumor Progression
endpoint definition
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician. Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration. From date of randomization to time of first documentation of progression, symptomatic deterioration or death due to any cause. Patients last known to be alive and progression free are considered at last date of contact.
time origin
Every 4 weeks while on treatment. Then every 3 months until progression, then six months for two years then annually until four years or until death, which ever occurs first.
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-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT00075764
outcome key
om-0001
source section id
NCT00075764-om-0001
source outcome index
1
endpoint
Clinical Benefit (CR, PR, Confirmed or Unconfirmed, or Stable Disease >= 24 Weeks).
endpoint definition
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable, Does not qualify for CR, PR, Progression or Symptomatic Deterioration. Clinical Benefit = CR + PR + Stable \>= 24 weeks
time origin
Every 4 weeks while on treatment. Then every 3 months until progression, then six months for two years then annually until four years or until death, which ever occurs first.
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-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT00075764
outcome key
om-0002
source section id
NCT00075764-om-0002
source outcome index
2
endpoint
Overall Survival
endpoint definition
From date of randomization to date of death due to any cause. Patients last known to be alive are censored at last date of contact.
time origin
Every 4 weeks while on treatment. Then every 3 months until progression, then six months for two years then annually until four years or until death, which ever occurs first.
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-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT00075764
outcome key
om-0003
source section id
NCT00075764-om-0003
source outcome index
3
endpoint
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
endpoint definition
Adverse Events (AEs) are reported by CTCAE version 3.0 terminology. For each patient, worst grade of each event type is reported. Grade3 (Severe), Grade4 (Life-threatening), Grade 5 (Fatal)
time origin
Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible patients who had received the protocol treatments were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
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-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT00075764
outcome key
om-0000
arm key
OG000
arm label
Arm I Anastrozole
regimen
Patients receive oral anastrozole once daily on days 1-28. anastrozole: Given orally
analyzed count
345
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00075764-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT00075764
outcome key
om-0000
arm key
OG001
arm label
Arm II Anastrozole and Fulvestrant
regimen
Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses. anastrozole: Given orally fulvestrant: Given intramuscularly
analyzed count
349
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00075764-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT00075764
outcome key
om-0001
arm key
OG000
arm label
Arm I Anastrozole
regimen
Patients receive oral anastrozole once daily on days 1-28. anastrozole: Given orally
analyzed count
345
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00075764-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT00075764
outcome key
om-0001
arm key
OG001
arm label
Arm II Anastrozole and Fulvestrant
regimen
Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses. anastrozole: Given orally fulvestrant: Given intramuscularly
analyzed count
349
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00075764-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT00075764
outcome key
om-0002
arm key
OG000
arm label
Arm I Anastrozole
regimen
Patients receive oral anastrozole once daily on days 1-28. anastrozole: Given orally
analyzed count
345
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00075764-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT00075764
outcome key
om-0002
arm key
OG001
arm label
Arm II Anastrozole and Fulvestrant
regimen
Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses. anastrozole: Given orally fulvestrant: Given intramuscularly
analyzed count
349
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00075764-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT00075764
outcome key
om-0003
arm key
OG000
arm label
Arm I Anastrozole
regimen
Patients receive oral anastrozole once daily on days 1-28
analyzed count
337
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00075764-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT00075764
outcome key
om-0003
arm key
OG001
arm label
Arm II Anastrozole and Fulvestrant
regimen
Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1 , 14, and 28 during course 1 and then on day 28 of the subsequent courses.
analyzed count
348
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00075764-om-0003#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT00075764
harm key
EG000
source section id
NCT00075764-ae
event group key
EG000
event group label
Anastrozole
serious affected
21
serious at risk
337
other affected
309
other at risk
337
frequency threshold
5
collection period
Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
event definition
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
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-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT00075764
harm key
EG001
source section id
NCT00075764-ae
event group key
EG001
event group label
Anastrozole & Fulvestrant
serious affected
48
serious at risk
348
other affected
322
other at risk
348
frequency threshold
5
collection period
Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
event definition
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
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