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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00310180
Recruitment Status : Active, not recruiting
First Posted : April 3, 2006
Results First Posted : March 12, 2019
Last Update Posted : September 9, 2020
Sponsor:
Collaborators:
American College of Surgeons
Cancer and Leukemia Group B
NSABP Foundation Inc
NCIC Clinical Trials Group
North Central Cancer Treatment Group
Southwest Oncology Group
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Breast Adenocarcinoma
Estrogen Receptor and/or Progesterone Receptor Positive
Stage IA Breast Cancer AJCC v7
Stage IB Breast Cancer AJCC v7
Stage IIA Breast Cancer AJCC v6 and v7
Stage IIB Breast Cancer AJCC v6 and v7
Stage IIIB Breast Cancer AJCC v7
Interventions Drug: Anastrozole
Drug: Exemestane
Other: Laboratory Biomarker Analysis
Drug: Letrozole
Other: Quality-of-Life Assessment
Radiation: Radiation Therapy
Drug: Tamoxifen Citrate
Enrollment 10273
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Arm A Arm B Arm C Arm D
Hide Arm/Group 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

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

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

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

Period Title: Overall Study
Started 1629 3458 3449 1737
No On-study Data 0 2 10 172
Ineligible 3 4 6 7
No Follow-up Data 7 55 131 245
Completed [1] 1619 3399 3312 1389
Not Completed 10 59 137 348
[1]
Patients analyzed in the main analysis
Arm/Group Title Arm A Arm B Arm C Arm D Total
Hide Arm/Group 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

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

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

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 of all reporting groups
Overall Number of Baseline Participants 1619 3399 3312 1389 9719
Hide Baseline Analysis Population Description
All eligible patients who had on-study data and follow-up data were included in the analysis
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1619 participants 3399 participants 3312 participants 1389 participants 9719 participants
<=40 years
58
   3.6%
154
   4.5%
157
   4.7%
79
   5.7%
448
   4.6%
41-50 years
371
  22.9%
985
  29.0%
920
  27.8%
330
  23.8%
2606
  26.8%
51-60 years
563
  34.8%
1235
  36.3%
1206
  36.4%
512
  36.9%
3516
  36.2%
61-70 years
518
  32.0%
868
  25.5%
895
  27.0%
395
  28.4%
2676
  27.5%
71-75 years
109
   6.7%
157
   4.6%
134
   4.0%
73
   5.3%
473
   4.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1619 participants 3399 participants 3312 participants 1389 participants 9719 participants
Female
1619
 100.0%
3399
 100.0%
3312
 100.0%
1389
 100.0%
9719
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1619 participants 3399 participants 3312 participants 1389 participants 9719 participants
American Indian or Alaska Native
8
   0.5%
11
   0.3%
16
   0.5%
4
   0.3%
39
   0.4%
Asian
82
   5.1%
140
   4.1%
132
   4.0%
51
   3.7%
405
   4.2%
Native Hawaiian or Other Pacific Islander
8
   0.5%
7
   0.2%
14
   0.4%
1
   0.1%
30
   0.3%
Black or African American
107
   6.6%
236
   6.9%
235
   7.1%
115
   8.3%
693
   7.1%
White
1361
  84.1%
2883
  84.8%
2783
  84.0%
1162
  83.7%
8189
  84.3%
More than one race
2
   0.1%
5
   0.1%
2
   0.1%
1
   0.1%
10
   0.1%
Unknown or Not Reported
51
   3.2%
117
   3.4%
130
   3.9%
55
   4.0%
353
   3.6%
Recurrence score   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1619 participants 3399 participants 3312 participants 1389 participants 9719 participants
0-5
432
  26.7%
0
   0.0%
0
   0.0%
0
   0.0%
432
   4.4%
6-10
1187
  73.3%
0
   0.0%
0
   0.0%
0
   0.0%
1187
  12.2%
11-15
0
   0.0%
1214
  35.7%
1159
  35.0%
0
   0.0%
2373
  24.4%
16-20
0
   0.0%
1368
  40.2%
1344
  40.6%
0
   0.0%
2712
  27.9%
21-25
0
   0.0%
817
  24.0%
809
  24.4%
0
   0.0%
1626
  16.7%
26-30
0
   0.0%
0
   0.0%
0
   0.0%
598
  43.1%
598
   6.2%
31-35
0
   0.0%
0
   0.0%
0
   0.0%
315
  22.7%
315
   3.2%
36-40
0
   0.0%
0
   0.0%
0
   0.0%
158
  11.4%
158
   1.6%
41-50
0
   0.0%
0
   0.0%
0
   0.0%
202
  14.5%
202
   2.1%
>50
0
   0.0%
0
   0.0%
0
   0.0%
116
   8.4%
116
   1.2%
[1]
Measure Description: The Oncotype DX assay is a 21-gene assay that predicts the likelihood of chemotherapy benefit and 10-year risk of distant recurrence to inform adjuvant treatment decisions in certain women with early-stage invasive breast cancer. Oncotype DX test results assign a Recurrence Score, and the Oncotype DX Recurrence Score is a continuous score, ranged between 0 and 100, that provides an individual estimate of the 10 year risk of distant recurrence and predicts the likelihood of benefit from chemotherapy. Higher score indicate higher risk of recurrence.
1.Primary Outcome
Title 5-year Disease-free Survival
Hide 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. 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.
Time Frame Assessed every 6 months within 5 years from registration and then annually up to 20 years, DFS rate estimated at 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who had on-study data and follow-up data were included in the analysis
Arm/Group Title Arm A Arm B Arm C Arm D
Hide Arm/Group 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

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

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

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 Number of Participants Analyzed 1619 3399 3312 1389
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
94.0
(92.6 to 95.1)
92.8
(91.8 to 93.6)
93.1
(92.1 to 93.9)
87.6
(85.5 to 89.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm B, Arm C
Comments This study uses a noninferiority design, but the noninferiority question is formulated using the conventional superiority null hypothesis of equal DFS on the two arms (that is, the null hypothesis is that Arm B is not inferior to Arm C). The alternative hypothesis is that Arm B has substantially worse DFS than Arm C, specified by a hazard ratio for B vs. C of 1.322.
Type of Statistical Test Superiority
Comments Since the noninferiority comparison is formulated using a conventional superiority null hypothesis described as above, a type II error corresponds to concluding that Arm B is not inferior when in fact it is. The design therefore uses a one-sided type I error of 10% and is planned to have 95% power (5% type II error). If the null hypothesis is rejected (at the one-sided 10% level), then it will be concluded that endocrine therapy alone is inferior to chemoendocrine therapy.
Statistical Test of Hypothesis P-Value 0.13
Comments One-sided p value for stratified Cox proportional hazard analysis, stratified on recurrence score, tumor size and menopausal status.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
0.94 to 1.24
Estimation Comments [Not Specified]
2.Secondary Outcome
Title 5-year Distant Recurrence-free Interval
Hide Description 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.
Time Frame Assessed every 6 months within 5 years from registration and then annually up to 20 years, DRFI rate estimated at 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who had on-study data and follow-up data
Arm/Group Title Arm A Arm B Arm C Arm D
Hide Arm/Group 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

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

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

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 Number of Participants Analyzed 1619 3399 3312 1389
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
99.3
(98.8 to 99.6)
98.0
(97.4 to 98.4)
98.2
(97.6 to 98.6)
93.0
(91.4 to 94.4)
3.Secondary Outcome
Title 5-year Recurrence-free Interval
Hide 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.
Time Frame Assessed every 6 months within 5 years from registration and then annually up to 20 years, RFS rate estimated at 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who had on-study data and follow-up data were included in the analysis
Arm/Group Title Arm A Arm B Arm C Arm D
Hide Arm/Group 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

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

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

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 Number of Participants Analyzed 1619 3399 3312 1389
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
98.8
(98.1 to 99.2)
96.9
(96.2 to 97.4)
97.0
(96.3 to 97.6)
91.0
(89.1 to 92.5)
4.Secondary Outcome
Title 5-year Overall Survival
Hide Description 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.
Time Frame Assessed every 6 months within 5 years from registration and then annually up to 20 years, OS rate estimated at 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who had on-study data and follow-up data were included in the analysis
Arm/Group Title Arm A Arm B Arm C Arm D
Hide Arm/Group 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

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

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

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 Number of Participants Analyzed 1619 3399 3312 1389
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
98.0
(97.2 to 98.6)
98.0
(97.5 to 98.5)
98.1
(97.6 to 98.5)
95.9
(94.6 to 96.9)
5.Secondary Outcome
Title 5-year Disease-free Survival by Age and Recurrence Score Groups
Hide 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.
Time Frame Assessed every 6 months within 5 years from registration and then annually up to 20 years, DFS rate estimated at 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who had on-study data and follow-up data were included in the analysis
Arm/Group Title Arm A Arm B Arm C Arm D
Hide Arm/Group 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

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

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

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 Number of Participants Analyzed 1619 3399 3312 1389
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
RS 0-10 & Age<=50
95.1
(92.4 to 96.8)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
RS 0-10 & Age 51-65
94.7
(93.0 to 96.1)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
RS 0-10 & Age 66-75
90.5
(86.5 to 93.3)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
RS 11-15 & Age <=50
NA [2] 
(NA to NA)
95.1
(92.5 to 96.8)
94.3
(91.1 to 96.3)
NA [2] 
(NA to NA)
RS 11-15 & Age 51-65
NA [2] 
(NA to NA)
95.5
(93.4 to 96.9)
93.9
(91.7 to 95.6)
NA [2] 
(NA to NA)
RS 11-15 & Age 66-75
NA [2] 
(NA to NA)
87.1
(80.9 to 91.4)
91.4
(85.3 to 95.0)
NA [2] 
(NA to NA)
RS 16-20 & Age <=50
NA [3] 
(NA to NA)
92.0
(89.0 to 94.2)
94.7
(92.1 to 96.4)
NA [3] 
(NA to NA)
RS 16-20 & Age 51-65
NA [3] 
(NA to NA)
94.3
(92.3 to 95.8)
92.2
(89.9 to 94.0)
NA [3] 
(NA to NA)
RS 16-20 & Age 66-75
NA [3] 
(NA to NA)
90.1
(84.6 to 93.8)
90.2
(84.8 to 93.8)
NA [3] 
(NA to NA)
RS 21-25 & Age <=50
NA [4] 
(NA to NA)
86.3
(81.1 to 90.2)
92.1
(87.7 to 95.0)
NA [4] 
(NA to NA)
RS 21-25 & Age 51-65
NA [4] 
(NA to NA)
91.6
(88.4 to 93.9)
93.4
(90.5 to 95.4)
NA [4] 
(NA to NA)
RS 21-25 & Age 66-75
NA [4] 
(NA to NA)
93.8
(87.9 to 96.8)
90.9
(84.2 to 94.9)
NA [4] 
(NA to NA)
RS >25 & Age <=50
NA [5] 
(NA to NA)
NA [5] 
(NA to NA)
NA [5] 
(NA to NA)
86.4
(82.1 to 89.7)
RS >25 & Age 51-65
NA [5] 
(NA to NA)
NA [5] 
(NA to NA)
NA [5] 
(NA to NA)
87.5
(84.7 to 89.9)
RS >25 & Age 66-75
NA [5] 
(NA to NA)
NA [5] 
(NA to NA)
NA [5] 
(NA to NA)
89.8
(84.4 to 93.4)
[1]
Patients with RS of 0-10 were assigned to arm A
[2]
Patients with RS of 11-15 were randomized to arm B or arm C
[3]
Patients with RS of 16-20 were randomized to arm B or arm C
[4]
Patients with RS of 21-25 were randomized to arm B or arm C
[5]
Patients with RS of >25 were assigned to arm D
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm B, Arm C
Comments 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
Type of Statistical Test Other
Comments Treatment-by-Age and RS subset was performed via Cox proportional hazard analysis
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
6.Secondary Outcome
Title To Compare the Outcomes Projected at 10 Years by Adjuvant! With Those Made by the Genomic Health Oncotype DX Test
Hide Description Adjuvant! is not currently available; additional work combining classical information with genomic tests will be reported separately.
Time Frame Assessed at 10 years after study entry
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome will never be analyzed.
Arm/Group Title Arm A Arm B Arm C Arm D
Hide Arm/Group 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

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

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

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 Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title 5-year Disease-free Survival by Individual RS Gene Groups
Hide 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. 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.
Time Frame Assessed every 6 months within 5 years from registration and then annually up to 20 years
Outcome Measure Data Not Reported
Time Frame Both the chemotherapy and endocrine therapy given on this study were standard therapies for this population. To simplify the effort required for participating sites, adverse event data were not collected.
Adverse Event Reporting Description Both the chemotherapy and endocrine therapy given on this study were standard therapies for this population. To simplify the effort required for participating sites, adverse event data were not collected.
 
Arm/Group Title Arm A Arm B Arm C Arm D
Hide Arm/Group 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

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

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

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

All-Cause Mortality
Arm A Arm B Arm C Arm D
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
Hide Serious Adverse Events
Arm A Arm B Arm C Arm D
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A Arm B Arm C Arm D
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: ECOG-ACRIN statistician
Organization: ECOG-ACRIN Cancer Research Group
Phone: 617-632-3000
EMail: eatrials@jimmy.harvard.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00310180    
Obsolete Identifiers: NCT00554931
Other Study ID Numbers: NCI-2009-00707
NCI-2009-00707 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ECOG-PACCT-1
06-482
CDR0000472066
PACCT-1
PACCT-1 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
PACCT-1 ( Other Identifier: CTEP )
U10CA180820 ( U.S. NIH Grant/Contract )
U10CA021115 ( U.S. NIH Grant/Contract )
First Submitted: March 29, 2006
First Posted: April 3, 2006
Results First Submitted: December 17, 2018
Results First Posted: March 12, 2019
Last Update Posted: September 9, 2020