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NCT00075764 · OUTCOME

Clinical Benefit (CR, PR, Confirmed or Unconfirmed, or Stable Disease >= 24 Weeks).

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
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
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

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

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 percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I Anastrozole70Not reportedNot reportedNot reportedNot reported
Arm II Anastrozole and Fulvestrant73Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        70
      2. group Id
        OG001
        value
        73
denoms
  1. counts
    1. group Id
      OG000
      value
      345
    2. group Id
      OG001
      value
      349
    units
    Participants
description
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
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
NUMBER
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
Clinical Benefit (CR, PR, Confirmed or Unconfirmed, or Stable Disease >= 24 Weeks).
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice