Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01272037 · OUTCOME

Distant Relapse-Free Survival (DRFS)

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

Time from date of randomization (2nd Registration) to date of invasive distant disease recurrence or death due to any cause. Participants last known to be alive who have not experienced distant recurrence are censored at their last contact date. This outcome requires continuing to follow the patient after local recurrence in order to ascertain subsequent distant recurrence. Kaplan-Meier estimates were calculated for the 5-year DRFS rate. Due to the results of the third prespecified interim analysis, prespecified separate analyses were conducted for all outcomes by menopausal status. The NCI and the data and safety monitoring committee recommended early reporting of the data. Due to subsequent data collection and data cleaning, the population of eligible and evaluable participants differs slightly between the reporting of this outcome and the Participant Flow section.

Analysis population: Eligible and evaluable participants

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 participants

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 Therapy96.1Not reportedNot reportedNot reportedNot reported
Endocrine Therapy Alone92.8Not reportedNot reportedNot reportedNot reported
Postmenopausal participants

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 Therapy94.4Not reportedNot reportedNot reportedNot reported
Endocrine Therapy Alone94.4Not 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
    0.39
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.87
    group Description
    This analysis includes only premenopausal participants.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    other Analysis Description
    To compare DRFS between the Chemo and Endocrine Therapy arm and the Endocrine Therapy Alone arm, a Cox model was used with adjustment for the continuous recurrence score.
    p Value
    0.009
    param Type
    Hazard Ratio (HR)
    param Value
    0.58
    statistical Method
    Regression, Cox
  2. ci Lower Limit
    0.81
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.37
    estimate Comment
    To compare DRFS between the Chemo and Endocrine Therapy arm and 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
    0.70
    param Type
    Hazard Ratio (HR)
    param Value
    1.05
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. ci Lower Limit
    0.39
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.87
    group Description
    This analysis includes only premenopausal participants.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    other Analysis Description
    To compare DRFS between the Chemo and Endocrine Therapy arm and the Endocrine Therapy Alone arm, a Cox model was used with adjustment for the continuous recurrence score.
    p Value
    0.009
    param Type
    Hazard Ratio (HR)
    param Value
    0.58
    statistical Method
    Regression, Cox
  2. ci Lower Limit
    0.81
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.37
    estimate Comment
    To compare DRFS between the Chemo and Endocrine Therapy arm and 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
    0.70
    param Type
    Hazard Ratio (HR)
    param Value
    1.05
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        96.1
      2. group Id
        OG001
        value
        92.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        829
      2. group Id
        OG001
        value
        826
      units
      Participants
    title
    Premenopausal participants
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        94.4
      2. group Id
        OG001
        value
        94.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        1658
      2. group Id
        OG001
        value
        1671
      units
      Participants
    title
    Postmenopausal participants
denoms
  1. counts
    1. group Id
      OG000
      value
      2487
    2. group Id
      OG001
      value
      2497
    units
    Participants
description
Time from date of randomization (2nd Registration) to date of invasive distant disease recurrence or death due to any cause. Participants last known to be alive who have not experienced distant recurrence are censored at their last contact date. This outcome requires continuing to follow the patient after local recurrence in order to ascertain subsequent distant recurrence. Kaplan-Meier estimates were calculated for the 5-year DRFS rate. Due to the results of the third prespecified interim analysis, prespecified separate analyses were conducted for all outcomes by menopausal status. The NCI and the data and safety monitoring committee recommended early reporting of the data. Due to subsequent data collection and data cleaning, the population of eligible and evaluable participants differs slightly between the reporting of this outcome and the Participant Flow 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
Eligible and evaluable participants
reporting Status
POSTED
time Frame
5 years after randomization
title
Distant Relapse-Free Survival (DRFS)
type
POST_HOC
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice