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NCT00295646 · OUTCOME

Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Recurrence-free Survival (RFS)

Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid · Source last updated 2024-03-15

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
years
Interval / dispersion
Inter-Quartile Range
Time frame
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.

What was measured

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

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

Groups in this outcome

AZ (Arimidex+Zoledronate)

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

TZ (Tamoxifen+Zoledronate)

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

AC (Arimidex Control)

Study Drug Arimidex (Anastrozole) anastrozole: 1 mg/d goserelin: 3.6 mg goserelin subcutaneously every 28 days

TC (Tamoxifen Control)

Study Drug Nolvadex (Tamoxifen) tamoxifen: 20 mg/d goserelin: 3.6 mg goserelin subcutaneously every 28 days

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
AZ (Arimidex+Zoledronate)450
TZ (Tamoxifen+Zoledronate)450
AC (Arimidex Control)453
TC (Tamoxifen Control)450

Reported measurements

Source class 1
Values in years · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
AZ (Arimidex+Zoledronate)NANot reportedNANANot applicable, estimates cannot be calculated due to too few events.
TZ (Tamoxifen+Zoledronate)NANot reportedNANANot applicable, estimates cannot be calculated due to too few events.
AC (Arimidex Control)NANot reportedNANANot applicable, estimates cannot be calculated due to too few events.
TC (Tamoxifen Control)NANot reportedNANANot applicable, estimates cannot be calculated due to too few events.

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.46
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.92
    group Description
    To determine the effect of Zoledronic Acid (AZ and TZ) compared to no Zoledronic Acid (AC and TC) in terms of recurrence-free survival. Recurrence-free survival is defined as the time from randomization to the first occurrence of a local or regional recurrence, cancer in the contralateral breast, distant metastasis, second primary carcinoma, or death related to breast cancer.
    group Ids
    1. OG000
    2. OG001
    3. OG002
    4. OG003
    non Inferiority Comment
    No multiplicity adjustment was applied.
    non Inferiority Type
    SUPERIORITY
    other Analysis Description
    From the Cox Proportional hazard model with Zoledronic Acid treatment fitted as a covariate. A hazard ratio \< 1.0 indicates a lower average event rate and a longer recurrence-free time for Zoledronic Acid relative to no Zoledronic Acid.
    p Value
    0.01
    param Type
    Cox Proportional Hazard
    param Value
    0.65
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.46
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.92
    group Description
    To determine the effect of Zoledronic Acid (AZ and TZ) compared to no Zoledronic Acid (AC and TC) in terms of recurrence-free survival. Recurrence-free survival is defined as the time from randomization to the first occurrence of a local or regional recurrence, cancer in the contralateral breast, distant metastasis, second primary carcinoma, or death related to breast cancer.
    group Ids
    1. OG000
    2. OG001
    3. OG002
    4. OG003
    non Inferiority Comment
    No multiplicity adjustment was applied.
    non Inferiority Type
    SUPERIORITY
    other Analysis Description
    From the Cox Proportional hazard model with Zoledronic Acid treatment fitted as a covariate. A hazard ratio \< 1.0 indicates a lower average event rate and a longer recurrence-free time for Zoledronic Acid relative to no Zoledronic Acid.
    p Value
    0.01
    param Type
    Cox Proportional Hazard
    param Value
    0.65
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        Not applicable, estimates cannot be calculated due to too few events.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Not applicable, estimates cannot be calculated due to too few events.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      3. comment
        Not applicable, estimates cannot be calculated due to too few events.
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      4. comment
        Not applicable, estimates cannot be calculated due to too few events.
        group Id
        OG003
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      450
    2. group Id
      OG001
      value
      450
    3. group Id
      OG002
      value
      453
    4. group Id
      OG003
      value
      450
    units
    Participants
description
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
dispersion Type
Inter-Quartile Range
groups
  1. description
    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
    id
    OG000
    title
    AZ (Arimidex+Zoledronate)
  2. description
    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
    id
    OG001
    title
    TZ (Tamoxifen+Zoledronate)
  3. description
    Study Drug Arimidex (Anastrozole) anastrozole: 1 mg/d goserelin: 3.6 mg goserelin subcutaneously every 28 days
    id
    OG002
    title
    AC (Arimidex Control)
  4. description
    Study Drug Nolvadex (Tamoxifen) tamoxifen: 20 mg/d goserelin: 3.6 mg goserelin subcutaneously every 28 days
    id
    OG003
    title
    TC (Tamoxifen Control)
param Type
MEDIAN
population Description
Intent-to-treat population: All participants assigned to one of the four treatment arms were included in the analysis
reporting Status
POSTED
time Frame
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.
title
Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Recurrence-free Survival (RFS)
type
SECONDARY
unit Of Measure
years

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Preserved source evidence · Not medical advice