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NCT00310180 · OUTCOME

5-year Recurrence-free Interval

Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial) · Source last updated 2026-09-08

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
95% Confidence Interval
Time frame
Assessed every 6 months within 5 years from registration and then annually up to 20 years, RFS rate estimated at 5 years

What was measured

Recurrence-free interval (RFS) is defined as time from date of randomization or registration to the date of first recurrence of breast cancer (ipsilateral breast tumor recurrence, local/regional recurrence, distant recurrence) or to the date of death with recurrence, if death is the first manifestation of recurrence. The distribution of RFS (eg, 5-year RFS rate) is estimated using Kaplan-Meier method.

Analysis population: All eligible patients who had on-study data and follow-up data were included in the analysis

Groups in this outcome

Arm A

Group 1 (Oncotype DX recurrence score =\< 10): Patients in this group receive hormone therapy with tamoxifen, anastrozole, letrozole, or exemestane PO for up to 5 years. Some patients then continue to receive hormone therapy for an additional 5 years. Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO

Arm B

Group 2 (Oncotype DX recurrence score 11-25): Patients receive hormone therapy with tamoxifen, anastrozole, letrozole, or exemestane PO for up to 5 years. Some patients then continue to receive hormone therapy for an additional 5 years. Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO

Arm C

Group 2 (Oncotype DX recurrence score 11-25): Patients receive standard combination chemotherapy at the discretion of the treating physician. Within 4 weeks after the last dose of chemotherapy, patients receive hormonal therapy as in Group 1 at the discretion of the treating physician. Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO Combination chemotherapy: including oral CMF, IV CMF, standard AC, dose dense AC, standard AC-T, dose dense AC-T, FEC, TAC, TC, other protocol-specified regimens if participating in other CTSU trials including chemotherapy, and other regimens not protocol-specified if not participating in CTSU trials

Arm D

Group 3 (Oncotype DX recurrence score \>= 26): Patients in this group receive combination chemotherapy followed by hormone therapy similar to the patients in Group 2 who are assigned to receive both types of treatment. Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO Combination chemotherapy: including oral CMF, IV CMF, standard AC, dose dense AC, standard AC-T, dose dense AC-T, FEC, TAC, TC, other protocol-specified regimens if participating in other CTSU trials including chemotherapy, and other regimens not protocol-specified if not participating in CTSU trials

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 A1619
Arm B3399
Arm C3312
Arm D1389

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A98.8Not reported98.199.2Not reported
Arm B96.9Not reported96.297.4Not reported
Arm C97.0Not reported96.397.6Not reported
Arm D91.0Not reported89.192.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        98.1
        upper Limit
        99.2
        value
        98.8
      2. group Id
        OG001
        lower Limit
        96.2
        upper Limit
        97.4
        value
        96.9
      3. group Id
        OG002
        lower Limit
        96.3
        upper Limit
        97.6
        value
        97.0
      4. group Id
        OG003
        lower Limit
        89.1
        upper Limit
        92.5
        value
        91.0
denoms
  1. counts
    1. group Id
      OG000
      value
      1619
    2. group Id
      OG001
      value
      3399
    3. group Id
      OG002
      value
      3312
    4. group Id
      OG003
      value
      1389
    units
    Participants
description
Recurrence-free interval (RFS) is defined as time from date of randomization or registration to the date of first recurrence of breast cancer (ipsilateral breast tumor recurrence, local/regional recurrence, distant recurrence) or to the date of death with recurrence, if death is the first manifestation of recurrence. The distribution of RFS (eg, 5-year RFS rate) is estimated using Kaplan-Meier method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Group 1 (Oncotype DX recurrence score =\< 10): Patients in this group receive hormone therapy with tamoxifen, anastrozole, letrozole, or exemestane PO for up to 5 years. Some patients then continue to receive hormone therapy for an additional 5 years. Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO
    id
    OG000
    title
    Arm A
  2. description
    Group 2 (Oncotype DX recurrence score 11-25): Patients receive hormone therapy with tamoxifen, anastrozole, letrozole, or exemestane PO for up to 5 years. Some patients then continue to receive hormone therapy for an additional 5 years. Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO
    id
    OG001
    title
    Arm B
  3. description
    Group 2 (Oncotype DX recurrence score 11-25): Patients receive standard combination chemotherapy at the discretion of the treating physician. Within 4 weeks after the last dose of chemotherapy, patients receive hormonal therapy as in Group 1 at the discretion of the treating physician. Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO Combination chemotherapy: including oral CMF, IV CMF, standard AC, dose dense AC, standard AC-T, dose dense AC-T, FEC, TAC, TC, other protocol-specified regimens if participating in other CTSU trials including chemotherapy, and other regimens not protocol-specified if not participating in CTSU trials
    id
    OG002
    title
    Arm C
  4. description
    Group 3 (Oncotype DX recurrence score \>= 26): Patients in this group receive combination chemotherapy followed by hormone therapy similar to the patients in Group 2 who are assigned to receive both types of treatment. Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO Combination chemotherapy: including oral CMF, IV CMF, standard AC, dose dense AC, standard AC-T, dose dense AC-T, FEC, TAC, TC, other protocol-specified regimens if participating in other CTSU trials including chemotherapy, and other regimens not protocol-specified if not participating in CTSU trials
    id
    OG003
    title
    Arm D
param Type
NUMBER
population Description
All eligible patients who had on-study data and follow-up data were included in the analysis
reporting Status
POSTED
time Frame
Assessed every 6 months within 5 years from registration and then annually up to 20 years, RFS rate estimated at 5 years
title
5-year Recurrence-free Interval
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice