5-year Disease-free Survival by Age and Recurrence Score Groups
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, DFS rate estimated at 5 years
What was measured
Disease-free survival (DFS) is defined to be time from randomization to first event, where the first event is any of ipsilateral breast tumor recurrence, local recurrence, regional recurrence, distant recurrence, contralateral second primary invasive cancer, second primary non-breast invasive cancer (excluding non-melanoma skin cancers), or death without evidence of recurrence. DFS is evaluated by recurrence score (0-10 vs. 11-15 vs. 16-20 vs. 21-25 vs. \>25) and age groups (\<=50 vs. 51-65 vs. 65-75). The distribution of DFS (eg, 5-year DFS 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
Group
Source count
Arm A
1619
Arm B
3399
Arm C
3312
Arm D
1389
Reported measurements
RS 0-10 & Age<=50
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Arm A
95.1
Not reported
92.4
96.8
Not reported
Arm B
NA
Not reported
NA
NA
Patients with RS of 0-10 were assigned to arm A
Arm C
NA
Not reported
NA
NA
Patients with RS of 0-10 were assigned to arm A
Arm D
NA
Not reported
NA
NA
Patients with RS of 0-10 were assigned to arm A
RS 0-10 & Age 51-65
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Arm A
94.7
Not reported
93.0
96.1
Not reported
Arm B
NA
Not reported
NA
NA
Patients with RS of 0-10 were assigned to arm A
Arm C
NA
Not reported
NA
NA
Patients with RS of 0-10 were assigned to arm A
Arm D
NA
Not reported
NA
NA
Patients with RS of 0-10 were assigned to arm A
RS 0-10 & Age 66-75
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Arm A
90.5
Not reported
86.5
93.3
Not reported
Arm B
NA
Not reported
NA
NA
Patients with RS of 0-10 were assigned to arm A
Arm C
NA
Not reported
NA
NA
Patients with RS of 0-10 were assigned to arm A
Arm D
NA
Not reported
NA
NA
Patients with RS of 0-10 were assigned to arm A
RS 11-15 & Age <=50
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Arm A
NA
Not reported
NA
NA
Patients with RS of 11-15 were randomized to arm B or arm C
Arm B
95.1
Not reported
92.5
96.8
Not reported
Arm C
94.3
Not reported
91.1
96.3
Not reported
Arm D
NA
Not reported
NA
NA
Patients with RS of 11-15 were randomized to arm B or arm C
RS 11-15 & Age 51-65
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Arm A
NA
Not reported
NA
NA
Patients with RS of 11-15 were randomized to arm B or arm C
Arm B
95.5
Not reported
93.4
96.9
Not reported
Arm C
93.9
Not reported
91.7
95.6
Not reported
Arm D
NA
Not reported
NA
NA
Patients with RS of 11-15 were randomized to arm B or arm C
RS 11-15 & Age 66-75
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Arm A
NA
Not reported
NA
NA
Patients with RS of 11-15 were randomized to arm B or arm C
Arm B
87.1
Not reported
80.9
91.4
Not reported
Arm C
91.4
Not reported
85.3
95.0
Not reported
Arm D
NA
Not reported
NA
NA
Patients with RS of 11-15 were randomized to arm B or arm C
RS 16-20 & Age <=50
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Arm A
NA
Not reported
NA
NA
Patients with RS of 16-20 were randomized to arm B or arm C
Arm B
92.0
Not reported
89.0
94.2
Not reported
Arm C
94.7
Not reported
92.1
96.4
Not reported
Arm D
NA
Not reported
NA
NA
Patients with RS of 16-20 were randomized to arm B or arm C
RS 16-20 & Age 51-65
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Arm A
NA
Not reported
NA
NA
Patients with RS of 16-20 were randomized to arm B or arm C
Arm B
94.3
Not reported
92.3
95.8
Not reported
Arm C
92.2
Not reported
89.9
94.0
Not reported
Arm D
NA
Not reported
NA
NA
Patients with RS of 16-20 were randomized to arm B or arm C
RS 16-20 & Age 66-75
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Arm A
NA
Not reported
NA
NA
Patients with RS of 16-20 were randomized to arm B or arm C
Arm B
90.1
Not reported
84.6
93.8
Not reported
Arm C
90.2
Not reported
84.8
93.8
Not reported
Arm D
NA
Not reported
NA
NA
Patients with RS of 16-20 were randomized to arm B or arm C
RS 21-25 & Age <=50
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Arm A
NA
Not reported
NA
NA
Patients with RS of 21-25 were randomized to arm B or arm C
Arm B
86.3
Not reported
81.1
90.2
Not reported
Arm C
92.1
Not reported
87.7
95.0
Not reported
Arm D
NA
Not reported
NA
NA
Patients with RS of 21-25 were randomized to arm B or arm C
RS 21-25 & Age 51-65
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Arm A
NA
Not reported
NA
NA
Patients with RS of 21-25 were randomized to arm B or arm C
Arm B
91.6
Not reported
88.4
93.9
Not reported
Arm C
93.4
Not reported
90.5
95.4
Not reported
Arm D
NA
Not reported
NA
NA
Patients with RS of 21-25 were randomized to arm B or arm C
RS 21-25 & Age 66-75
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Arm A
NA
Not reported
NA
NA
Patients with RS of 21-25 were randomized to arm B or arm C
Arm B
93.8
Not reported
87.9
96.8
Not reported
Arm C
90.9
Not reported
84.2
94.9
Not reported
Arm D
NA
Not reported
NA
NA
Patients with RS of 21-25 were randomized to arm B or arm C
RS >25 & Age <=50
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Arm A
NA
Not reported
NA
NA
Patients with RS of \>25 were assigned to arm D
Arm B
NA
Not reported
NA
NA
Patients with RS of \>25 were assigned to arm D
Arm C
NA
Not reported
NA
NA
Patients with RS of \>25 were assigned to arm D
Arm D
86.4
Not reported
82.1
89.7
Not reported
RS >25 & Age 51-65
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Arm A
NA
Not reported
NA
NA
Patients with RS of \>25 were assigned to arm D
Arm B
NA
Not reported
NA
NA
Patients with RS of \>25 were assigned to arm D
Arm C
NA
Not reported
NA
NA
Patients with RS of \>25 were assigned to arm D
Arm D
87.5
Not reported
84.7
89.9
Not reported
RS >25 & Age 66-75
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Arm A
NA
Not reported
NA
NA
Patients with RS of \>25 were assigned to arm D
Arm B
NA
Not reported
NA
NA
Patients with RS of \>25 were assigned to arm D
Arm C
NA
Not reported
NA
NA
Patients with RS of \>25 were assigned to arm D
Arm D
89.8
Not reported
84.4
93.4
Not reported
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
group Description
Treatment interaction test was performed for the 9 age by RS subsets (3 groups for each, age groups \<=50 vs. 51-65 vs. 66-75; RS groups 0-10 vs. 11-25 vs. \>25) in patients randomized to arms B and C
group Ids
OG001
OG002
non Inferiority Comment
Treatment-by-Age and RS subset was performed via Cox proportional hazard analysis
non Inferiority Type
OTHER
p Value
0.004
statistical Method
Regression, Cox
Complete source fields
analyses
group Description
Treatment interaction test was performed for the 9 age by RS subsets (3 groups for each, age groups \<=50 vs. 51-65 vs. 66-75; RS groups 0-10 vs. 11-25 vs. \>25) in patients randomized to arms B and C
group Ids
OG001
OG002
non Inferiority Comment
Treatment-by-Age and RS subset was performed via Cox proportional hazard analysis
non Inferiority Type
OTHER
p Value
0.004
statistical Method
Regression, Cox
classes
categories
measurements
group Id
OG000
lower Limit
92.4
upper Limit
96.8
value
95.1
comment
Patients with RS of 0-10 were assigned to arm A
group Id
OG001
lower Limit
NA
upper Limit
NA
value
NA
comment
Patients with RS of 0-10 were assigned to arm A
group Id
OG002
lower Limit
NA
upper Limit
NA
value
NA
comment
Patients with RS of 0-10 were assigned to arm A
group Id
OG003
lower Limit
NA
upper Limit
NA
value
NA
title
RS 0-10 & Age<=50
categories
measurements
group Id
OG000
lower Limit
93.0
upper Limit
96.1
value
94.7
comment
Patients with RS of 0-10 were assigned to arm A
group Id
OG001
lower Limit
NA
upper Limit
NA
value
NA
comment
Patients with RS of 0-10 were assigned to arm A
group Id
OG002
lower Limit
NA
upper Limit
NA
value
NA
comment
Patients with RS of 0-10 were assigned to arm A
group Id
OG003
lower Limit
NA
upper Limit
NA
value
NA
title
RS 0-10 & Age 51-65
categories
measurements
group Id
OG000
lower Limit
86.5
upper Limit
93.3
value
90.5
comment
Patients with RS of 0-10 were assigned to arm A
group Id
OG001
lower Limit
NA
upper Limit
NA
value
NA
comment
Patients with RS of 0-10 were assigned to arm A
group Id
OG002
lower Limit
NA
upper Limit
NA
value
NA
comment
Patients with RS of 0-10 were assigned to arm A
group Id
OG003
lower Limit
NA
upper Limit
NA
value
NA
title
RS 0-10 & Age 66-75
categories
measurements
comment
Patients with RS of 11-15 were randomized to arm B or arm C
group Id
OG000
lower Limit
NA
upper Limit
NA
value
NA
group Id
OG001
lower Limit
92.5
upper Limit
96.8
value
95.1
group Id
OG002
lower Limit
91.1
upper Limit
96.3
value
94.3
comment
Patients with RS of 11-15 were randomized to arm B or arm C
group Id
OG003
lower Limit
NA
upper Limit
NA
value
NA
title
RS 11-15 & Age <=50
categories
measurements
comment
Patients with RS of 11-15 were randomized to arm B or arm C
group Id
OG000
lower Limit
NA
upper Limit
NA
value
NA
group Id
OG001
lower Limit
93.4
upper Limit
96.9
value
95.5
group Id
OG002
lower Limit
91.7
upper Limit
95.6
value
93.9
comment
Patients with RS of 11-15 were randomized to arm B or arm C
group Id
OG003
lower Limit
NA
upper Limit
NA
value
NA
title
RS 11-15 & Age 51-65
categories
measurements
comment
Patients with RS of 11-15 were randomized to arm B or arm C
group Id
OG000
lower Limit
NA
upper Limit
NA
value
NA
group Id
OG001
lower Limit
80.9
upper Limit
91.4
value
87.1
group Id
OG002
lower Limit
85.3
upper Limit
95.0
value
91.4
comment
Patients with RS of 11-15 were randomized to arm B or arm C
group Id
OG003
lower Limit
NA
upper Limit
NA
value
NA
title
RS 11-15 & Age 66-75
categories
measurements
comment
Patients with RS of 16-20 were randomized to arm B or arm C
group Id
OG000
lower Limit
NA
upper Limit
NA
value
NA
group Id
OG001
lower Limit
89.0
upper Limit
94.2
value
92.0
group Id
OG002
lower Limit
92.1
upper Limit
96.4
value
94.7
comment
Patients with RS of 16-20 were randomized to arm B or arm C
group Id
OG003
lower Limit
NA
upper Limit
NA
value
NA
title
RS 16-20 & Age <=50
categories
measurements
comment
Patients with RS of 16-20 were randomized to arm B or arm C
group Id
OG000
lower Limit
NA
upper Limit
NA
value
NA
group Id
OG001
lower Limit
92.3
upper Limit
95.8
value
94.3
group Id
OG002
lower Limit
89.9
upper Limit
94.0
value
92.2
comment
Patients with RS of 16-20 were randomized to arm B or arm C
group Id
OG003
lower Limit
NA
upper Limit
NA
value
NA
title
RS 16-20 & Age 51-65
categories
measurements
comment
Patients with RS of 16-20 were randomized to arm B or arm C
group Id
OG000
lower Limit
NA
upper Limit
NA
value
NA
group Id
OG001
lower Limit
84.6
upper Limit
93.8
value
90.1
group Id
OG002
lower Limit
84.8
upper Limit
93.8
value
90.2
comment
Patients with RS of 16-20 were randomized to arm B or arm C
group Id
OG003
lower Limit
NA
upper Limit
NA
value
NA
title
RS 16-20 & Age 66-75
categories
measurements
comment
Patients with RS of 21-25 were randomized to arm B or arm C
group Id
OG000
lower Limit
NA
upper Limit
NA
value
NA
group Id
OG001
lower Limit
81.1
upper Limit
90.2
value
86.3
group Id
OG002
lower Limit
87.7
upper Limit
95.0
value
92.1
comment
Patients with RS of 21-25 were randomized to arm B or arm C
group Id
OG003
lower Limit
NA
upper Limit
NA
value
NA
title
RS 21-25 & Age <=50
categories
measurements
comment
Patients with RS of 21-25 were randomized to arm B or arm C
group Id
OG000
lower Limit
NA
upper Limit
NA
value
NA
group Id
OG001
lower Limit
88.4
upper Limit
93.9
value
91.6
group Id
OG002
lower Limit
90.5
upper Limit
95.4
value
93.4
comment
Patients with RS of 21-25 were randomized to arm B or arm C
group Id
OG003
lower Limit
NA
upper Limit
NA
value
NA
title
RS 21-25 & Age 51-65
categories
measurements
comment
Patients with RS of 21-25 were randomized to arm B or arm C
group Id
OG000
lower Limit
NA
upper Limit
NA
value
NA
group Id
OG001
lower Limit
87.9
upper Limit
96.8
value
93.8
group Id
OG002
lower Limit
84.2
upper Limit
94.9
value
90.9
comment
Patients with RS of 21-25 were randomized to arm B or arm C
group Id
OG003
lower Limit
NA
upper Limit
NA
value
NA
title
RS 21-25 & Age 66-75
denoms
counts
group Id
OG000
value
1619
group Id
OG001
value
3399
group Id
OG002
value
3312
group Id
OG003
value
1389
units
Participants
description
Disease-free survival (DFS) is defined to be time from randomization to first event, where the first event is any of ipsilateral breast tumor recurrence, local recurrence, regional recurrence, distant recurrence, contralateral second primary invasive cancer, second primary non-breast invasive cancer (excluding non-melanoma skin cancers), or death without evidence of recurrence. DFS is evaluated by recurrence score (0-10 vs. 11-15 vs. 16-20 vs. 21-25 vs. \>25) and age groups (\<=50 vs. 51-65 vs. 65-75). The distribution of DFS (eg, 5-year DFS rate) is estimated using Kaplan-Meier method.
dispersion Type
95% Confidence Interval
groups
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
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
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
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, DFS rate estimated at 5 years
title
5-year Disease-free Survival by Age and Recurrence Score Groups
Triangle