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NCT01272037 · OUTCOME

Invasive Disease-Free Survival (IDFS)

Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer · Source last updated 2026-08-28

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
5 years after randomization

What was measured

From date of randomization (2nd Registration) to date of first invasive recurrence (local, regional or distant), second invasive primary cancer (breast or not), or death due to any cause. Patients last known to be alive who have not experienced recurrence or second primary cancer are censored at their last contact date. This is the STEEP definition of invasive disease-free survival. Kaplan-Meier estimates were calculated for the 5-year IDFS rate. Due to the results of the third prespecified interim analysis, prespecified separate analyses were conducted for all outcomes by menopausal status (see Statistical Analysis 2). The NCI and data and safety monitoring committee recommended early reporting of the data. After the primary analysis, changes in eligibility status were identified for three participants, making the population of eligible and evaluable participants different between the reporting of this outcome and both the Participant Flow section and the Adverse Events section.

Analysis population: For the participants flow and baseline characteristics summary, 5018 eligible participants were included. However, among them, there were 34 participants (10 in the chemo and endocrine arm, and 24 in the endocrine alone arm) that withdrew consent immediately after randomization; thus these participants were excluded from the survival analyses.

Groups in this outcome

Chemo and Endocrine Therapy

Participants receive a protocol-approved chemotherapy regimen based on the participant and/or physician preference. Participants then receive a protocol-approved adjuvant endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.

Endocrine Therapy Alone

Participants receive a protocol-approved endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Chemo and Endocrine Therapy2487
Endocrine Therapy Alone2497

Reported measurements

Premenopausal

Analysis denominator · Participants

GroupSource count
Chemo and Endocrine Therapy829
Endocrine Therapy Alone826
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Chemo and Endocrine Therapy93.9Not reportedNot reportedNot reportedNot reported
Endocrine Therapy Alone89.0Not reportedNot reportedNot reportedNot reported
Postmenopausal

Analysis denominator · Participants

GroupSource count
Chemo and Endocrine Therapy1658
Endocrine Therapy Alone1671
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Chemo and Endocrine Therapy91.3Not reportedNot reportedNot reportedNot reported
Endocrine Therapy Alone91.9Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    0.98
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.05
    group Description
    This test describes the interaction of the treatment arm with the recurrence score in the analysis of invasive disease-free survival in the overall study population, to determine whether chemotherapy benefit depends on the recurrence score. If the interaction was statistically significant, the interaction term was planned to be included in the Cox model to evaluate the invasive disease-free survival outcome.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.35
    param Type
    Hazard Ratio (HR)
    param Value
    1.02
    statistical Comment
    A Cox model was used that included treatment arm, recurrence score, menopausal status, and the chemotherapy\*recurrence score interaction term.
    statistical Method
    Regression, Cox
  2. ci Lower Limit
    1.15
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.54
    group Description
    This test describes the interaction of the treatment arm with menopausal status (one of the study stratification factors) in the analysis of invasive disease-free survival in the overall study population, to determine whether chemotherapy benefit depends on menopausal status. If the interaction was statistically significant, separate analyses of IDFS were planned to be conducted by menopausal status.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.008
    param Type
    Hazard Ratio (HR)
    param Value
    1.71
    statistical Comment
    A Cox model was used that included treatment arm, recurrence score, menopausal status, and the chemotherapy\*menopausal status interaction term.
    statistical Method
    Regression, Cox
  3. ci Lower Limit
    0.43
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.83
    estimate Comment
    To compare the Chemo and Endocrine Therapy arm to the Endocrine Therapy Alone arm, a Cox model was used with adjustment for the continuous recurrence score.
    group Description
    This analysis includes only premenopausal participants.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.002
    param Type
    Hazard Ratio (HR)
    param Value
    0.60
    statistical Method
    Regression, Cox
  4. ci Lower Limit
    0.82
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.26
    estimate Comment
    To compare the Chemo and Endocrine Therapy arm to the Endocrine Therapy Alone arm, a Cox model was used with adjustment for the continuous recurrence score.
    group Description
    This analysis includes only postmenopausal participants.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.89
    param Type
    Hazard Ratio (HR)
    param Value
    1.02
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. ci Lower Limit
    0.98
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.05
    group Description
    This test describes the interaction of the treatment arm with the recurrence score in the analysis of invasive disease-free survival in the overall study population, to determine whether chemotherapy benefit depends on the recurrence score. If the interaction was statistically significant, the interaction term was planned to be included in the Cox model to evaluate the invasive disease-free survival outcome.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.35
    param Type
    Hazard Ratio (HR)
    param Value
    1.02
    statistical Comment
    A Cox model was used that included treatment arm, recurrence score, menopausal status, and the chemotherapy\*recurrence score interaction term.
    statistical Method
    Regression, Cox
  2. ci Lower Limit
    1.15
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.54
    group Description
    This test describes the interaction of the treatment arm with menopausal status (one of the study stratification factors) in the analysis of invasive disease-free survival in the overall study population, to determine whether chemotherapy benefit depends on menopausal status. If the interaction was statistically significant, separate analyses of IDFS were planned to be conducted by menopausal status.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.008
    param Type
    Hazard Ratio (HR)
    param Value
    1.71
    statistical Comment
    A Cox model was used that included treatment arm, recurrence score, menopausal status, and the chemotherapy\*menopausal status interaction term.
    statistical Method
    Regression, Cox
  3. ci Lower Limit
    0.43
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.83
    estimate Comment
    To compare the Chemo and Endocrine Therapy arm to the Endocrine Therapy Alone arm, a Cox model was used with adjustment for the continuous recurrence score.
    group Description
    This analysis includes only premenopausal participants.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.002
    param Type
    Hazard Ratio (HR)
    param Value
    0.60
    statistical Method
    Regression, Cox
  4. ci Lower Limit
    0.82
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.26
    estimate Comment
    To compare the Chemo and Endocrine Therapy arm to the Endocrine Therapy Alone arm, a Cox model was used with adjustment for the continuous recurrence score.
    group Description
    This analysis includes only postmenopausal participants.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.89
    param Type
    Hazard Ratio (HR)
    param Value
    1.02
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        93.9
      2. group Id
        OG001
        value
        89.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        829
      2. group Id
        OG001
        value
        826
      units
      Participants
    title
    Premenopausal
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        91.3
      2. group Id
        OG001
        value
        91.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        1658
      2. group Id
        OG001
        value
        1671
      units
      Participants
    title
    Postmenopausal
denoms
  1. counts
    1. group Id
      OG000
      value
      2487
    2. group Id
      OG001
      value
      2497
    units
    Participants
description
From date of randomization (2nd Registration) to date of first invasive recurrence (local, regional or distant), second invasive primary cancer (breast or not), or death due to any cause. Patients last known to be alive who have not experienced recurrence or second primary cancer are censored at their last contact date. This is the STEEP definition of invasive disease-free survival. Kaplan-Meier estimates were calculated for the 5-year IDFS rate. Due to the results of the third prespecified interim analysis, prespecified separate analyses were conducted for all outcomes by menopausal status (see Statistical Analysis 2). The NCI and data and safety monitoring committee recommended early reporting of the data. After the primary analysis, changes in eligibility status were identified for three participants, making the population of eligible and evaluable participants different between the reporting of this outcome and both the Participant Flow section and the Adverse Events section.
groups
  1. description
    Participants receive a protocol-approved chemotherapy regimen based on the participant and/or physician preference. Participants then receive a protocol-approved adjuvant endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Chemo and Endocrine Therapy
  2. description
    Participants receive a protocol-approved endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.
    id
    OG001
    title
    Endocrine Therapy Alone
param Type
NUMBER
population Description
For the participants flow and baseline characteristics summary, 5018 eligible participants were included. However, among them, there were 34 participants (10 in the chemo and endocrine arm, and 24 in the endocrine alone arm) that withdrew consent immediately after randomization; thus these participants were excluded from the survival analyses.
reporting Status
POSTED
time Frame
5 years after randomization
title
Invasive Disease-Free Survival (IDFS)
type
PRIMARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice