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NCT00295646 · STUDY IN CONTEXT

Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid

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

DFS is defined as time from randomization to first occurrence of a local, regional, or distant recurrence, second primary carcinoma (including contralateral breast cancer), or death from any cause

Intent-to-treat population: All participants assigned to one of the four treatment arms were included in the analysis

→

primary · POSTED

DFS is defined as time from randomization to first occurrence of a local, regional, or distant recurrence, second primary carcinoma (including contralateral breast cancer), or death from any cause

Intent-to-treat population: All participants assigned to one of the four treatment arms were included in the analysis

→

secondary · POSTED

RFS is defined as time from randomization to first occurrence of a local, regional, or distant recurrence, second primary carcinoma (including contralateral breast cancer), or death from breast cancer

Intent-to-treat population: All participants assigned to one of the four treatment arms were included in the analysis

→

secondary · POSTED

RFS is defined as time from randomization to first occurrence of a local, regional, or distant recurrence, second primary carcinoma (including contralateral breast cancer), or death from breast cancer

Intent-to-treat population: All participants assigned to one of the four treatment arms were included in the analysis

→

secondary · POSTED

OS is defined as time from randomization to death from any cause

Intent-to-treat population: All participants assigned to one of the four treatment arms were included in the analysis

→

secondary · POSTED

OS is defined as time from randomization to death from any cause

Intent-to-treat population: All participants assigned to one of the four treatment arms were included in the analysis.

→

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
NCT00295646
trial label
Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid
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
4
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00295646
    outcome key
    om-0000
    source section id
    NCT00295646-om-0000
    source outcome index
    0
    endpoint
    Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS)
    endpoint definition
    DFS is defined as time from randomization to first occurrence of a local, regional, or distant recurrence, second primary carcinoma (including contralateral breast cancer), or death from any cause
    time origin
    Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat population: All participants assigned to one of the four treatment arms were included in the analysis
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00295646
    outcome key
    om-0001
    source section id
    NCT00295646-om-0001
    source outcome index
    1
    endpoint
    Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS)
    endpoint definition
    DFS is defined as time from randomization to first occurrence of a local, regional, or distant recurrence, second primary carcinoma (including contralateral breast cancer), or death from any cause
    time origin
    Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat population: All participants assigned to one of the four treatment arms were included in the analysis
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00295646
    outcome key
    om-0002
    source section id
    NCT00295646-om-0002
    source outcome index
    2
    endpoint
    Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Recurrence-free Survival (RFS)
    endpoint definition
    RFS is defined as time from randomization to first occurrence of a local, regional, or distant recurrence, second primary carcinoma (including contralateral breast cancer), or death from breast cancer
    time origin
    Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat population: All participants assigned to one of the four treatment arms were included in the analysis
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00295646
    outcome key
    om-0003
    source section id
    NCT00295646-om-0003
    source outcome index
    3
    endpoint
    Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Recurrence-free Survival (RFS)
    endpoint definition
    RFS is defined as time from randomization to first occurrence of a local, regional, or distant recurrence, second primary carcinoma (including contralateral breast cancer), or death from breast cancer
    time origin
    Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat population: All participants assigned to one of the four treatment arms were included in the analysis
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00295646
    outcome key
    om-0004
    source section id
    NCT00295646-om-0004
    source outcome index
    4
    endpoint
    Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Overall Survival (OS)
    endpoint definition
    OS is defined as time from randomization to death from any cause
    time origin
    Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat population: All participants assigned to one of the four treatment arms were included in the analysis
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00295646
    outcome key
    om-0005
    source section id
    NCT00295646-om-0005
    source outcome index
    5
    endpoint
    Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Overall Survival (OS)
    endpoint definition
    OS is defined as time from randomization to death from any cause
    time origin
    Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat population: All participants assigned to one of the four treatment arms were included in the analysis.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00295646
    outcome key
    om-0000
    arm key
    OG000
    arm label
    AZ (Arimidex+Zoledronate)
    regimen
    Study Drugs Arimidex (Anastrozole), Zometa (Zoledronate; zoledronic acid) anastrozole: 1 mg/d zoledronic acid: 4 mg q6m goserelin: 3.6 mg goserelin subcutaneously every 28 days
    analyzed count
    450
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00295646-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00295646
    outcome key
    om-0000
    arm key
    OG001
    arm label
    TZ (Tamoxifen+Zoledronate)
    regimen
    Study Drugs Nolvadex (Tamoxifen), Zometa (Zoledronate; zoledronic acid) tamoxifen: 20 mg/d zoledronic acid: 4 mg q6m goserelin: 3.6 mg goserelin subcutaneously every 28 days
    analyzed count
    450
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00295646-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00295646
    outcome key
    om-0000
    arm key
    OG002
    arm label
    AC (Arimidex Control)
    regimen
    Study Drug Arimidex (Anastrozole) anastrozole: 1 mg/d goserelin: 3.6 mg goserelin subcutaneously every 28 days
    analyzed count
    453
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00295646-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00295646
    outcome key
    om-0000
    arm key
    OG003
    arm label
    TC (Tamoxifen Control)
    regimen
    Study Drug Nolvadex (Tamoxifen) tamoxifen: 20 mg/d goserelin: 3.6 mg goserelin subcutaneously every 28 days
    analyzed count
    450
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00295646-om-0000#groups/OG003
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00295646
    outcome key
    om-0001
    arm key
    OG000
    arm label
    AZ (Arimidex+Zoledronate)
    regimen
    Study Drugs Arimidex (Anastrozole), Zometa (Zoledronate; zoledronic acid) anastrozole: 1 mg/d zoledronic acid: 4 mg q6m goserelin: 3.6 mg goserelin subcutaneously every 28 days
    analyzed count
    450
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00295646-om-0001#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00295646
    outcome key
    om-0001
    arm key
    OG001
    arm label
    TZ (Tamoxifen+Zoledronate)
    regimen
    Study Drugs Nolvadex (Tamoxifen), Zometa (Zoledronate; zoledronic acid) tamoxifen: 20 mg/d zoledronic acid: 4 mg q6m goserelin: 3.6 mg goserelin subcutaneously every 28 days
    analyzed count
    450
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00295646-om-0001#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00295646
    outcome key
    om-0001
    arm key
    OG002
    arm label
    AC (Arimidex Control)
    regimen
    Study Drug Arimidex (Anastrozole) anastrozole: 1 mg/d goserelin: 3.6 mg goserelin subcutaneously every 28 days
    analyzed count
    453
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00295646-om-0001#groups/OG002
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00295646
    outcome key
    om-0001
    arm key
    OG003
    arm label
    TC (Tamoxifen Control)
    regimen
    Study Drug Nolvadex (Tamoxifen) tamoxifen: 20 mg/d goserelin: 3.6 mg goserelin subcutaneously every 28 days
    analyzed count
    450
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00295646-om-0001#groups/OG003
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00295646
    outcome key
    om-0002
    arm key
    OG000
    arm label
    AZ (Arimidex+Zoledronate)
    regimen
    Study Drugs Arimidex (Anastrozole), Zometa (Zoledronate; zoledronic acid) anastrozole: 1 mg/d zoledronic acid: 4 mg q6m goserelin: 3.6 mg goserelin subcutaneously every 28 days
    analyzed count
    450
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00295646-om-0002#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00295646
    outcome key
    om-0002
    arm key
    OG001
    arm label
    TZ (Tamoxifen+Zoledronate)
    regimen
    Study Drugs Nolvadex (Tamoxifen), Zometa (Zoledronate; zoledronic acid) tamoxifen: 20 mg/d zoledronic acid: 4 mg q6m goserelin: 3.6 mg goserelin subcutaneously every 28 days
    analyzed count
    450
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00295646-om-0002#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00295646
    outcome key
    om-0002
    arm key
    OG002
    arm label
    AC (Arimidex Control)
    regimen
    Study Drug Arimidex (Anastrozole) anastrozole: 1 mg/d goserelin: 3.6 mg goserelin subcutaneously every 28 days
    analyzed count
    453
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00295646-om-0002#groups/OG002
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00295646
    outcome key
    om-0002
    arm key
    OG003
    arm label
    TC (Tamoxifen Control)
    regimen
    Study Drug Nolvadex (Tamoxifen) tamoxifen: 20 mg/d goserelin: 3.6 mg goserelin subcutaneously every 28 days
    analyzed count
    450
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00295646-om-0002#groups/OG003
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00295646
    harm key
    EG000
    source section id
    NCT00295646-ae
    event group key
    EG000
    event group label
    AZ (Arimidex+Zoledronate)
    serious affected
    67
    serious at risk
    450
    other affected
    355
    other at risk
    450
    frequency threshold
    0
    collection period
    Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
    event definition
    All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00295646
    harm key
    EG001
    source section id
    NCT00295646-ae
    event group key
    EG001
    event group label
    TZ (Tamoxifen+Zoledronate)
    serious affected
    103
    serious at risk
    450
    other affected
    320
    other at risk
    450
    frequency threshold
    0
    collection period
    Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
    event definition
    All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00295646
    harm key
    EG002
    source section id
    NCT00295646-ae
    event group key
    EG002
    event group label
    AC (Arimidex Control)
    serious affected
    55
    serious at risk
    453
    other affected
    340
    other at risk
    453
    frequency threshold
    0
    collection period
    Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
    event definition
    All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00295646
    harm key
    EG003
    source section id
    NCT00295646-ae
    event group key
    EG003
    event group label
    TC (Tamoxifen Control)
    serious affected
    93
    serious at risk
    450
    other affected
    290
    other at risk
    450
    frequency threshold
    0
    collection period
    Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
    event definition
    All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
    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