Trial Outcomes & Findings for Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial) (NCT NCT00310180)

Last Updated: 2025-11-13

Results Overview

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. The distribution of DFS (eg, 5-year DFS rate) is estimated using Kaplan-Meier method, and compared between the two randomized arms (arm B vs. arm C) using stratified log rank test and stratified Cox proportional hazard model.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

10273 participants

Primary outcome timeframe

Assessed every 6 months within 5 years from registration and then annually up to 20 years, DFS rate estimated at 5 years

Results posted on

2025-11-13

Participant Flow

This study was activated on April 7, 2006 and closed to registrations on October 6, 2010. A total of 11,232 patients were preregistered for Recurrence Score evaluation and 10,273 proceeded to register on the study.

Patients needed to be preregistered to the trial for ONCOTYPE recurrence score test, patients then were assigned or randomized to one of the four arms based on the recurrence score.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	1629	3458	3449	1737
Overall Study No On-study Data	0	2	10	172
Overall Study Ineligible	3	4	6	7
Overall Study No Follow-up Data	7	55	131	245
Overall Study COMPLETED	1619	3399	3312	1389
Overall Study NOT COMPLETED	10	59	137	348

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A n=1619 Participants 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 n=3399 Participants 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 n=3312 Participants 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 n=1389 Participants 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	Total n=9719 Participants Total of all reporting groups
Age, Customized <=40 years	58 Participants n=10 Participants	154 Participants n=10 Participants	157 Participants n=20 Participants	79 Participants n=45 Participants	448 Participants n=44 Participants
Age, Customized 41-50 years	371 Participants n=10 Participants	985 Participants n=10 Participants	920 Participants n=20 Participants	330 Participants n=45 Participants	2606 Participants n=44 Participants
Age, Customized 51-60 years	563 Participants n=10 Participants	1235 Participants n=10 Participants	1206 Participants n=20 Participants	512 Participants n=45 Participants	3516 Participants n=44 Participants
Age, Customized 61-70 years	518 Participants n=10 Participants	868 Participants n=10 Participants	895 Participants n=20 Participants	395 Participants n=45 Participants	2676 Participants n=44 Participants
Age, Customized 71-75 years	109 Participants n=10 Participants	157 Participants n=10 Participants	134 Participants n=20 Participants	73 Participants n=45 Participants	473 Participants n=44 Participants
Sex: Female, Male Female	1619 Participants n=10 Participants	3399 Participants n=10 Participants	3312 Participants n=20 Participants	1389 Participants n=45 Participants	9719 Participants n=44 Participants
Sex: Female, Male Male	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	0 Participants n=44 Participants
Race (NIH/OMB) American Indian or Alaska Native	8 Participants n=10 Participants	11 Participants n=10 Participants	16 Participants n=20 Participants	4 Participants n=45 Participants	39 Participants n=44 Participants
Race (NIH/OMB) Asian	82 Participants n=10 Participants	140 Participants n=10 Participants	132 Participants n=20 Participants	51 Participants n=45 Participants	405 Participants n=44 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	8 Participants n=10 Participants	7 Participants n=10 Participants	14 Participants n=20 Participants	1 Participants n=45 Participants	30 Participants n=44 Participants
Race (NIH/OMB) Black or African American	107 Participants n=10 Participants	236 Participants n=10 Participants	235 Participants n=20 Participants	115 Participants n=45 Participants	693 Participants n=44 Participants
Race (NIH/OMB) White	1361 Participants n=10 Participants	2883 Participants n=10 Participants	2783 Participants n=20 Participants	1162 Participants n=45 Participants	8189 Participants n=44 Participants
Race (NIH/OMB) More than one race	2 Participants n=10 Participants	5 Participants n=10 Participants	2 Participants n=20 Participants	1 Participants n=45 Participants	10 Participants n=44 Participants
Race (NIH/OMB) Unknown or Not Reported	51 Participants n=10 Participants	117 Participants n=10 Participants	130 Participants n=20 Participants	55 Participants n=45 Participants	353 Participants n=44 Participants
Recurrence score 0-5	432 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	432 Participants n=44 Participants
Recurrence score 6-10	1187 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	1187 Participants n=44 Participants
Recurrence score 11-15	0 Participants n=10 Participants	1214 Participants n=10 Participants	1159 Participants n=20 Participants	0 Participants n=45 Participants	2373 Participants n=44 Participants
Recurrence score 16-20	0 Participants n=10 Participants	1368 Participants n=10 Participants	1344 Participants n=20 Participants	0 Participants n=45 Participants	2712 Participants n=44 Participants
Recurrence score 21-25	0 Participants n=10 Participants	817 Participants n=10 Participants	809 Participants n=20 Participants	0 Participants n=45 Participants	1626 Participants n=44 Participants
Recurrence score 26-30	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	598 Participants n=45 Participants	598 Participants n=44 Participants
Recurrence score 31-35	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	315 Participants n=45 Participants	315 Participants n=44 Participants
Recurrence score 36-40	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	158 Participants n=45 Participants	158 Participants n=44 Participants
Recurrence score 41-50	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	202 Participants n=45 Participants	202 Participants n=44 Participants
Recurrence score >50	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	116 Participants n=45 Participants	116 Participants n=44 Participants

PRIMARY outcome

Timeframe: Assessed every 6 months within 5 years from registration and then annually up to 20 years, DFS rate estimated at 5 years

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

Outcome measures

Outcome measures
Measure	Arm A n=1619 Participants 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 n=3399 Participants 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 n=3312 Participants 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 n=1389 Participants 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
5-year Disease-free Survival	94.0 percentage of participants Interval 92.6 to 95.1	92.8 percentage of participants Interval 91.8 to 93.6	93.1 percentage of participants Interval 92.1 to 93.9	87.6 percentage of participants Interval 85.5 to 89.4

SECONDARY outcome

Timeframe: Assessed every 6 months within 5 years from registration and then annually up to 20 years, DRFI rate estimated at 5 years

Population: All eligible patients who had on-study data and follow-up data

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

Outcome measures

Outcome measures
Measure	Arm A n=1619 Participants 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 n=3399 Participants 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 n=3312 Participants 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 n=1389 Participants 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
5-year Distant Recurrence-free Interval	99.3 percentage of participants Interval 98.8 to 99.6	98.0 percentage of participants Interval 97.4 to 98.4	98.2 percentage of participants Interval 97.6 to 98.6	93.0 percentage of participants Interval 91.4 to 94.4

SECONDARY outcome

Timeframe: Assessed every 6 months within 5 years from registration and then annually up to 20 years, RFS rate estimated at 5 years

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

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.

Outcome measures

Outcome measures
Measure	Arm A n=1619 Participants 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 n=3399 Participants 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 n=3312 Participants 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 n=1389 Participants 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
5-year Recurrence-free Interval	98.8 percentage of participants Interval 98.1 to 99.2	96.9 percentage of participants Interval 96.2 to 97.4	97.0 percentage of participants Interval 96.3 to 97.6	91.0 percentage of participants Interval 89.1 to 92.5

SECONDARY outcome

Timeframe: Assessed every 6 months within 5 years from registration and then annually up to 20 years, OS rate estimated at 5 years

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

Overall survival (OS) is defined as time from date of randomization or registration to date of death from any cause. The distribution of OS (eg, 5-year OS rate) is estimated using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Arm A n=1619 Participants 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 n=3399 Participants 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 n=3312 Participants 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 n=1389 Participants 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
5-year Overall Survival	98.0 percentage of participants Interval 97.2 to 98.6	98.0 percentage of participants Interval 97.5 to 98.5	98.1 percentage of participants Interval 97.6 to 98.5	95.9 percentage of participants Interval 94.6 to 96.9

SECONDARY outcome

Timeframe: Assessed every 6 months within 5 years from registration and then annually up to 20 years, DFS rate estimated at 5 years

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

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.

Outcome measures

SECONDARY outcome

Timeframe: Assessed at 10 years after study entry

Population: Outcome will never be analyzed.

Adjuvant! is not currently available; additional work combining classical information with genomic tests will be reported separately.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Assessed every 6 months within 5 years from registration and then annually up to 20 years

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. The distribution of DFS (eg, 5-year DFS rate) is estimated using Kaplan-Meier method. 5-year DFS by individual RS gene groups (Proliferation Gene Group, HER2 Gene Group, ER Gene Group, Invasion Gene Group, and Other Genes) will be estimated in each arm.

Outcome measures

Outcome data not reported

Adverse Events

Arm A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm C

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm D

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

ECOG-ACRIN statistician

ECOG-ACRIN Cancer Research Group

Phone: 617-632-3000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Arm A n=1619 Participants 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 n=3399 Participants 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 n=3312 Participants 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 n=1389 Participants 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
5-year Disease-free Survival by Age and Recurrence Score Groups RS 0-10 & Age<=50	95.1 percentage of participants Interval 92.4 to 96.8	NA percentage of participants Patients with RS of 0-10 were assigned to arm A	NA percentage of participants Patients with RS of 0-10 were assigned to arm A	NA percentage of participants Patients with RS of 0-10 were assigned to arm A
5-year Disease-free Survival by Age and Recurrence Score Groups RS 0-10 & Age 51-65	94.7 percentage of participants Interval 93.0 to 96.1	NA percentage of participants Patients with RS of 0-10 were assigned to arm A	NA percentage of participants Patients with RS of 0-10 were assigned to arm A	NA percentage of participants Patients with RS of 0-10 were assigned to arm A
5-year Disease-free Survival by Age and Recurrence Score Groups RS 0-10 & Age 66-75	90.5 percentage of participants Interval 86.5 to 93.3	NA percentage of participants Patients with RS of 0-10 were assigned to arm A	NA percentage of participants Patients with RS of 0-10 were assigned to arm A	NA percentage of participants Patients with RS of 0-10 were assigned to arm A
5-year Disease-free Survival by Age and Recurrence Score Groups RS 11-15 & Age <=50	NA percentage of participants Patients with RS of 11-15 were randomized to arm B or arm C	95.1 percentage of participants Interval 92.5 to 96.8	94.3 percentage of participants Interval 91.1 to 96.3	NA percentage of participants Patients with RS of 11-15 were randomized to arm B or arm C
5-year Disease-free Survival by Age and Recurrence Score Groups RS 11-15 & Age 51-65	NA percentage of participants Patients with RS of 11-15 were randomized to arm B or arm C	95.5 percentage of participants Interval 93.4 to 96.9	93.9 percentage of participants Interval 91.7 to 95.6	NA percentage of participants Patients with RS of 11-15 were randomized to arm B or arm C
5-year Disease-free Survival by Age and Recurrence Score Groups RS 11-15 & Age 66-75	NA percentage of participants Patients with RS of 11-15 were randomized to arm B or arm C	87.1 percentage of participants Interval 80.9 to 91.4	91.4 percentage of participants Interval 85.3 to 95.0	NA percentage of participants Patients with RS of 11-15 were randomized to arm B or arm C
5-year Disease-free Survival by Age and Recurrence Score Groups RS 16-20 & Age <=50	NA percentage of participants Patients with RS of 16-20 were randomized to arm B or arm C	92.0 percentage of participants Interval 89.0 to 94.2	94.7 percentage of participants Interval 92.1 to 96.4	NA percentage of participants Patients with RS of 16-20 were randomized to arm B or arm C
5-year Disease-free Survival by Age and Recurrence Score Groups RS 16-20 & Age 51-65	NA percentage of participants Patients with RS of 16-20 were randomized to arm B or arm C	94.3 percentage of participants Interval 92.3 to 95.8	92.2 percentage of participants Interval 89.9 to 94.0	NA percentage of participants Patients with RS of 16-20 were randomized to arm B or arm C
5-year Disease-free Survival by Age and Recurrence Score Groups RS 16-20 & Age 66-75	NA percentage of participants Patients with RS of 16-20 were randomized to arm B or arm C	90.1 percentage of participants Interval 84.6 to 93.8	90.2 percentage of participants Interval 84.8 to 93.8	NA percentage of participants Patients with RS of 16-20 were randomized to arm B or arm C
5-year Disease-free Survival by Age and Recurrence Score Groups RS 21-25 & Age <=50	NA percentage of participants Patients with RS of 21-25 were randomized to arm B or arm C	86.3 percentage of participants Interval 81.1 to 90.2	92.1 percentage of participants Interval 87.7 to 95.0	NA percentage of participants Patients with RS of 21-25 were randomized to arm B or arm C
5-year Disease-free Survival by Age and Recurrence Score Groups RS 21-25 & Age 51-65	NA percentage of participants Patients with RS of 21-25 were randomized to arm B or arm C	91.6 percentage of participants Interval 88.4 to 93.9	93.4 percentage of participants Interval 90.5 to 95.4	NA percentage of participants Patients with RS of 21-25 were randomized to arm B or arm C
5-year Disease-free Survival by Age and Recurrence Score Groups RS 21-25 & Age 66-75	NA percentage of participants Patients with RS of 21-25 were randomized to arm B or arm C	93.8 percentage of participants Interval 87.9 to 96.8	90.9 percentage of participants Interval 84.2 to 94.9	NA percentage of participants Patients with RS of 21-25 were randomized to arm B or arm C
5-year Disease-free Survival by Age and Recurrence Score Groups RS >25 & Age <=50	NA percentage of participants Patients with RS of \>25 were assigned to arm D	NA percentage of participants Patients with RS of \>25 were assigned to arm D	NA percentage of participants Patients with RS of \>25 were assigned to arm D	86.4 percentage of participants Interval 82.1 to 89.7
5-year Disease-free Survival by Age and Recurrence Score Groups RS >25 & Age 51-65	NA percentage of participants Patients with RS of \>25 were assigned to arm D	NA percentage of participants Patients with RS of \>25 were assigned to arm D	NA percentage of participants Patients with RS of \>25 were assigned to arm D	87.5 percentage of participants Interval 84.7 to 89.9
5-year Disease-free Survival by Age and Recurrence Score Groups RS >25 & Age 66-75	NA percentage of participants Patients with RS of \>25 were assigned to arm D	NA percentage of participants Patients with RS of \>25 were assigned to arm D	NA percentage of participants Patients with RS of \>25 were assigned to arm D	89.8 percentage of participants Interval 84.4 to 93.4