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NCT00075764 · OUTCOME

Time to Tumor Progression

S0226 Anastrozole With or Without Fulvestrant as First-Line Therapy in Postmenopausal Women With Metastatic Breast Cancer · Source last updated 2021-01-13

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
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.

What was measured

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.

Groups in this outcome

Arm I Anastrozole

Patients receive oral anastrozole once daily on days 1-28. anastrozole: Given orally

Arm II Anastrozole and Fulvestrant

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

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

Analysis denominator · Participants

GroupSource count
Arm I Anastrozole345
Arm II Anastrozole and Fulvestrant349

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I Anastrozole13.5Not reported12.115.1Not reported
Arm II Anastrozole and Fulvestrant15.0Not reported13.218.4Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.68
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.94
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.007
    param Type
    Hazard Ratio (HR)
    param Value
    0.80
    statistical Comment
    Two-sided stratified log-rank test
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.68
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.94
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.007
    param Type
    Hazard Ratio (HR)
    param Value
    0.80
    statistical Comment
    Two-sided stratified log-rank test
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12.1
        upper Limit
        15.1
        value
        13.5
      2. group Id
        OG001
        lower Limit
        13.2
        upper Limit
        18.4
        value
        15.0
denoms
  1. counts
    1. group Id
      OG000
      value
      345
    2. group Id
      OG001
      value
      349
    units
    Participants
description
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.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive oral anastrozole once daily on days 1-28. anastrozole: Given orally
    id
    OG000
    title
    Arm I Anastrozole
  2. description
    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
    id
    OG001
    title
    Arm II Anastrozole and Fulvestrant
param Type
MEDIAN
reporting Status
POSTED
time Frame
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.
title
Time to Tumor Progression
type
PRIMARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice