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S0221 Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer

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: NCT00070564
Recruitment Status : Active, not recruiting
First Posted : October 7, 2003
Results First Posted : April 17, 2017
Last Update Posted : December 30, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Biological: pegfilgrastim
Drug: AC regimen
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: paclitaxel
Enrollment 3294
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I Arm II Arm III Arm IV Arm V Arm VI
Hide Arm/Group Description

(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.

Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.

(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.

Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.

Period Title: Overall Study
Started 678 693 697 648 282 296
Completed 478 490 526 481 203 244
Not Completed 200 203 171 167 79 52
Reason Not Completed
Progression             2             4             7             7             1             0
Delinquent             1             4             2             0             0             0
Adverse Event             150             142             120             108             63             36
Death             4             1             5             3             0             1
Other, not protocol specified             17             15             14             19             6             7
Withdrawal by Subject             26             37             23             30             8             8
Not reported             0             0             0             0             1             0
Arm/Group Title Arm I Arm II Arm III Arm IV Arm V ARM VI Total
Hide Arm/Group Description

(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.

Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.

(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.

Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.

Total of all reporting groups
Overall Number of Baseline Participants 664 683 681 639 277 294 3238
Hide Baseline Analysis Population Description
Only eligible and analyzable patients were included in the analysis.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 664 participants 683 participants 681 participants 639 participants 277 participants 294 participants 3238 participants
50.5
(25 to 77)
50.9
(23 to 79)
51.8
(23 to 86)
50.7
(21 to 76)
52.7
(31 to 79)
53.2
(23 to 76)
52.7
(21 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 664 participants 683 participants 681 participants 639 participants 277 participants 294 participants 3238 participants
Female
658
  99.1%
679
  99.4%
676
  99.3%
636
  99.5%
275
  99.3%
291
  99.0%
3215
  99.3%
Male
6
   0.9%
4
   0.6%
5
   0.7%
3
   0.5%
2
   0.7%
3
   1.0%
23
   0.7%
Black Race  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 664 participants 683 participants 681 participants 639 participants 277 participants 294 participants 3238 participants
73
  11.0%
77
  11.3%
74
  10.9%
78
  12.2%
31
  11.2%
44
  15.0%
377
  11.6%
Menopausal status (females)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 658 participants 679 participants 676 participants 636 participants 275 participants 291 participants 3215 participants
Premenopausal
326
  49.5%
325
  47.9%
308
  45.6%
299
  47.0%
124
  45.1%
123
  42.3%
1505
  46.8%
Postmenopausal
332
  50.5%
354
  52.1%
368
  54.4%
337
  53.0%
148
  53.8%
166
  57.0%
1705
  53.0%
Unknown
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
   1.1%
2
   0.7%
5
   0.2%
[1]
Measure Analysis Population Description: Only females of the total eligible and analyzable patients were included in menopausal status measurement.
Nodal status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 664 participants 683 participants 681 participants 639 participants 277 participants 294 participants 3238 participants
Negative
161
  24.2%
153
  22.4%
159
  23.3%
146
  22.8%
105
  37.9%
109
  37.1%
833
  25.7%
1-3 positive nodes
260
  39.2%
266
  38.9%
276
  40.5%
245
  38.3%
103
  37.2%
98
  33.3%
1248
  38.5%
>= 4 positive nodes
241
  36.3%
264
  38.7%
243
  35.7%
244
  38.2%
68
  24.5%
87
  29.6%
1147
  35.4%
unknown
2
   0.3%
0
   0.0%
3
   0.4%
4
   0.6%
1
   0.4%
0
   0.0%
10
   0.3%
ER/PgR   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 664 participants 683 participants 681 participants 639 participants 277 participants 294 participants 3238 participants
Negative (both negative)
212
  31.9%
226
  33.1%
232
  34.1%
206
  32.2%
99
  35.7%
108
  36.7%
1083
  33.4%
Positive (either or both positive)
450
  67.8%
456
  66.8%
446
  65.5%
430
  67.3%
178
  64.3%
185
  62.9%
2145
  66.2%
Unknown
2
   0.3%
1
   0.1%
3
   0.4%
3
   0.5%
0
   0.0%
1
   0.3%
10
   0.3%
[1]
Measure Description: ER, estrogen receptor; PgR, progesterone receptor
HER2   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 664 participants 683 participants 681 participants 639 participants 277 participants 294 participants 3238 participants
Negative
528
  79.5%
556
  81.4%
554
  81.4%
525
  82.2%
208
  75.1%
235
  79.9%
2606
  80.5%
Positive
125
  18.8%
123
  18.0%
118
  17.3%
109
  17.1%
69
  24.9%
57
  19.4%
601
  18.6%
Unknown
11
   1.7%
4
   0.6%
9
   1.3%
5
   0.8%
0
   0.0%
2
   0.7%
31
   1.0%
[1]
Measure Description: HER2, human epidermal growth factor receptor 2.
1.Primary Outcome
Title Disease-free Survival
Hide Description Disease-free survival (DFS) defined as time from registration (randomization assignment) to first instance of disease recurrence (local, regional, or distant), new breast primary tumor, or death as a result of any cause. The results are entered as disease free survival at year 5.
Time Frame every 6 months (annually for mammograms) for 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Only eligible and analyzable patients were included in this analysis. Two patients in Arm II and one patient in Arm IV with no follow-up were excluded.
Arm/Group Title Arm I Arm II Arm III Arm IV Arm V Arm VI
Hide Arm/Group Description:

(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.

Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.

(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.

Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.

Overall Number of Participants Analyzed 664 681 681 638 277 294
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
83
(80 to 86)
79
(76 to 82)
81
(78 to 84)
81
(78 to 84)
84
(79 to 88)
85
(80 to 89)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I, Arm II
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.32
Confidence Interval (2-Sided) 95%
1.04 to 1.68
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm I, Arm III
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.072
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.24
Confidence Interval (2-Sided) 95%
0.98 to 1.59
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Arm I, Arm IV
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.38
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.12
Confidence Interval (2-Sided) 95%
0.87 to 1.44
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Arm I, Arm II, Arm III, Arm IV
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Arm V, Arm VI
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.733
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.61 to 1.41
Estimation Comments [Not Specified]
2.Primary Outcome
Title Overall Survival
Hide Description Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5.
Time Frame Every 6 months for 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Only eligible and analyzable patients were included in this analysis. Two patients in Arm II and one patient in Arm IV with no follow-up were excluded.
Arm/Group Title Arm I Arm II Arm III Arm IV Arm V Arm VI
Hide Arm/Group Description:

(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.

Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.

(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.

Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.

Overall Number of Participants Analyzed 664 681 681 638 277 294
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
90
(87 to 92)
87
(84 to 90)
87
(84 to 89)
87
(84 to 90)
90
(86 to 93)
91
(87 to 94)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I, Arm II
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.44
Confidence Interval (2-Sided) 95%
1.08 to 1.93
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm I, Arm III
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.46
Confidence Interval (2-Sided) 95%
1.09 to 1.95
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Arm I, Arm IV
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.24
Confidence Interval (2-Sided) 95%
0.91 to 1.68
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Arm I, Arm II, Arm III, Arm IV
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.040
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Arm V, Arm VI
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.724
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.54 to 1.53
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hide Description Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time Frame Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
Hide Outcome Measure Data
Hide Analysis Population Description
Limited to patients who started treatment, who did not have a major deviation in the treatment protocol, and whose toxicity profile has been completed.
Arm/Group Title ARM I ARM II ARM III ARM IV ARM V ARM VI
Hide Arm/Group Description:
(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.
(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.

Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.

Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.

(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.

Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.

Overall Number of Participants Analyzed 654 663 674 624 275 291
Measure Type: Number
Unit of Measure: Participants
ALT, SGPT (serum glutamic pyruvic transaminase) 7 4 3 4 3 1
AST, SGOT 5 3 2 2 4 1
Acidosis (metabolic or respiratory) 1 0 0 0 0 0
Adult respiratory distress syndrome (ARDS) 1 0 2 0 0 1
Albumin, serum-low (hypoalbuminemia) 1 2 0 0 0 0
Alkaline phosphatase 0 0 0 1 0 0
Allergic reaction/hypersensitivity 8 12 6 3 5 5
Anorexia 6 5 8 4 0 2
Apnea 0 0 1 0 0 0
Arthritis (non-septic) 0 0 0 0 0 1
Ataxia (incoordination) 2 0 1 0 0 0
Bilirubin (hyperbilirubinemia) 3 0 2 0 0 0
Bladder spasms 0 2 0 0 0 0
Blood/Bone Marrow-Other 1 2 2 0 0 0
Bronchospasm, wheezing 0 1 0 0 1 0
CNS cerebrovascular ischemia 0 0 1 1 0 0
Calcium, serum-high (hypercalcemia) 0 0 0 1 0 0
Calcium, serum-low (hypocalcemia) 2 1 1 0 1 1
Cardiac General-Other 2 1 1 0 0 0
Cardiac troponin I (cTnI) 0 0 1 1 0 0
Cardiac troponin T (cTnT) 3 0 2 0 0 0
Cardiac-ischemia/infarction 3 0 1 0 1 0
Cardiopulmonary arrest, cause unknown (non-fatal) 0 0 1 0 0 0
Cataract 0 1 0 0 0 0
Cholecystitis 1 0 0 0 0 0
Colitis 1 0 2 1 1 0
Colitis, infectious (e.g., Clostridium difficile) 0 0 1 2 0 0
Conduction abnormality - Asystole 0 0 1 0 0 0
Confusion 1 1 0 0 0 1
Constipation 3 3 3 3 1 0
Constitutional Symptoms-Other 1 1 0 0 0 0
Cough 3 5 4 0 1 1
Creatinine 1 0 0 0 0 0
Cystitis 0 3 0 0 0 0
Cytokine release syndrome/acute infusion reaction 0 0 0 2 1 0
DIC (disseminated intravascular coagulation) 1 0 0 0 0 0
Death - Multi-organ failure 1 0 1 0 0 0
Death not associated with CTCAE term - Death NOS 0 0 0 1 0 1
Dehydration 8 7 12 3 4 4
Dermatology/Skin-Other 0 3 0 1 1 0
Diarrhea 27 18 24 23 8 6
Distention/bloating, abdominal 0 0 1 1 0 0
Dizziness 5 2 2 5 0 2
Dysphagia (difficulty swallowing) 2 0 1 3 0 0
Dyspnea (shortness of breath) 21 18 25 16 2 4
Edema: head and neck 0 1 0 0 0 0
Edema: limb 0 2 2 3 1 1
Encephalopathy 1 0 0 0 0 0
Endocrine-Other 0 0 1 0 0 0
Esophagitis 5 4 0 3 0 0
Extrapyramidal/involuntary movement/restlessness 0 0 0 1 0 0
Extremity-upper (function) 0 0 1 0 0 0
Eyelid dysfunction 0 0 0 0 1 0
FEV(1) 0 0 1 0 0 0
Fatigue (asthenia, lethargy, malaise) 77 59 87 65 20 14
Febrile neutropenia 49 9 38 20 16 14
Fever in absence of neutropenia, ANC lt1.0x10e9/L 2 3 3 1 1 1
Fistula, GI - Oral cavity 0 0 0 1 0 0
Flu-like syndrome 0 1 1 1 0 0
Fracture 0 2 0 0 0 2
GGT (gamma-glutamyl transpeptidase) 2 0 0 1 0 0
Gastritis (including bile reflux gastritis) 0 0 0 1 0 0
Gastrointestinal-Other 1 0 0 3 0 0
Glucose, serum-high (hyperglycemia) 13 17 9 13 6 5
Glucose, serum-low (hypoglycemia) 4 2 0 1 0 0
Hair loss/Alopecia (scalp or body) 3 0 0 0 0 0
Heartburn/dyspepsia 1 0 3 5 1 1
Hemoglobin 87 48 101 47 21 19
Hemorrhage, GI - Lower GI NOS 0 1 0 1 1 0
Hemorrhage, GI - Oral cavity 0 0 0 1 0 0
Hemorrhage, GI - Rectum 1 0 0 0 1 0
Hemorrhage, GI - Upper GI NOS 1 0 0 0 0 0
Hemorrhage, GU - Urinary NOS 0 0 0 1 0 0
Hemorrhage, GU - Vagina 0 0 1 0 0 0
Hemorrhage, pulmonary/upper respiratory - Nose 0 0 0 1 0 1
Hemorrhage/Bleeding-Other 1 0 0 1 0 0
Hemorrhoids 1 3 1 0 0 1
Hot flashes/flushes 0 2 1 0 1 1
Hypertension 2 1 1 1 2 2
Hypotension 4 1 4 3 0 3
Hypoxia 2 3 3 2 3 1
INR (of prothrombin time) 2 5 1 3 1 2
Ileus, GI (functional obstruction of bowel) 0 0 1 1 0 0
Inf (clin/microbio) w/Gr 3-4 neuts - Abdomen NOS 0 1 0 0 0 0
Inf (clin/microbio) w/Gr 3-4 neuts - Bladder 0 1 1 0 0 0
Inf (clin/microbio) w/Gr 3-4 neuts - Blood 2 1 2 0 2 3
Inf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel 0 1 0 0 0 0
Inf (clin/microbio) w/Gr 3-4 neuts - Colon 0 0 0 0 0 1
Inf (clin/microbio) w/Gr 3-4 neuts - Eye NOS 0 0 1 0 0 0
Inf (clin/microbio) w/Gr 3-4 neuts - Lung 4 2 2 4 1 0
Inf (clin/microbio) w/Gr 3-4 neuts - Lymphatic 0 0 2 0 0 0
Inf (clin/microbio) w/Gr 3-4 neuts - Meninges 0 0 0 0 0 1
Inf (clin/microbio) w/Gr 3-4 neuts - Middle ear 0 0 1 1 0 0
Inf (clin/microbio) w/Gr 3-4 neuts - Mucosa 1 1 0 0 0 0
Inf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums 0 0 1 0 0 1
Inf (clin/microbio) w/Gr 3-4 neuts - Paranasal 0 0 0 2 0 0
Inf (clin/microbio) w/Gr 3-4 neuts - Pharynx 0 0 1 0 0 0
Inf (clin/microbio) w/Gr 3-4 neuts - Skin 3 1 2 3 1 2
Inf (clin/microbio) w/Gr 3-4 neuts - Soft tissue 0 0 0 0 1 0
Inf (clin/microbio) w/Gr 3-4 neuts - UTI 1 2 0 1 0 0
Inf (clin/microbio) w/Gr 3-4 neuts - Upper airway 0 0 1 0 0 0
Inf (clin/microbio) w/Gr 3-4 neuts - Wound 0 2 3 0 0 0
Inf w/normal ANC or Gr 1-2 neutrophils - Bil. tree 0 0 0 0 1 0
Inf w/normal ANC or Gr 1-2 neutrophils - Bladder 0 1 1 1 0 0
Inf w/normal ANC or Gr 1-2 neutrophils - Blood 2 0 0 2 0 1
Inf w/normal ANC or Gr 1-2 neutrophils - Bronchus 0 2 0 2 1 0
Inf w/normal ANC or Gr 1-2 neutrophils - Catheter 0 2 2 0 0 0
Inf w/normal ANC or Gr 1-2 neutrophils - Colon 0 0 1 1 0 1
Inf w/normal ANC or Gr 1-2 neutrophils - Dental 0 1 0 1 0 0
Inf w/normal ANC or Gr 1-2 neutrophils - Esophagus 0 0 0 1 0 0
Inf w/normal ANC or Gr 1-2 neutrophils - Kidney 1 1 0 0 1 0
Inf w/normal ANC or Gr 1-2 neutrophils - Lung 7 5 10 5 2 4
Inf w/normal ANC or Gr 1-2 neutrophils - Meninges 2 0 0 0 0 0
Inf w/normal ANC or Gr 1-2 neutrophils - Muscle 0 0 0 1 0 0
Inf w/normal ANC or Gr 1-2 neutrophils - Neck NOS 0 1 0 0 0 0
Inf w/normal ANC or Gr 1-2 neutrophils - Oral cav 1 0 0 1 0 0
Inf w/normal ANC or Gr 1-2 neutrophils - Sinus 2 2 2 0 0 0
Inf w/normal ANC or Gr 1-2 neutrophils - Skin 7 6 8 11 4 4
Inf w/normal ANC or Gr 1-2 neutrophils - Soft tiss 1 0 1 0 0 0
Inf w/normal ANC or Gr 1-2 neutrophils - UTI 5 3 0 1 0 0
Inf w/normal ANC or Gr 1-2 neutrophils - Ungual 0 1 1 2 0 1
Inf w/normal ANC or Gr 1-2 neutrophils - Up airway 0 1 2 2 1 1
Inf w/normal ANC or Gr 1-2 neutrophils - Vagina 0 1 0 1 0 0
Inf w/normal ANC or Gr 1-2 neutrophils - Vulva 1 0 0 0 0 0
Inf w/normal ANC or Gr 1-2 neutrophils - Wound 0 1 0 2 1 3
Inf w/normal ANC or Gr 1-2 neutrophils - perioral 0 0 1 0 0 0
Inf w/normal ANC or Gr 1-2 neutrophils -Nerve-cran 0 0 1 0 0 0
Inf w/normal ANC or Gr 1-2 neutrophils-Foreign bod 0 1 0 0 0 1
Infection with normal ANC or Grade 1 or 2 neutroph 1 0 1 1 0 0
Infection with unknown ANC - Appendix 1 0 0 0 0 0
Infection with unknown ANC - Blood 0 0 0 0 0 1
Infection with unknown ANC - Catheter-related 0 1 0 0 0 0
Infection with unknown ANC - Foreign body (e.g., g 0 0 0 0 0 1
Infection with unknown ANC - Kidney 0 0 0 1 0 0
Infection with unknown ANC - Lung (pneumonia) 0 1 0 0 1 0
Infection with unknown ANC - Skin (cellulitis) 1 0 0 0 0 1
Infection with unknown ANC - Wound 0 0 0 0 1 0
Infection-Other 4 3 5 0 2 1
Injection site reaction/extravasation changes 1 0 1 0 0 0
Insomnia 1 1 0 6 1 1
Intra-operative injury - Peripheral sensory NOS 0 0 0 0 0 2
Intra-operative injury - Spinal cord 0 0 0 1 0 0
Irregular menses (change from baseline) 1 1 0 0 0 0
Joint-function 0 1 0 0 0 0
Left ventricular diastolic dysfunction 3 0 3 0 0 0
Left ventricular systolic dysfunction 7 2 8 2 1 1
Leukocytes (total WBC) 128 98 157 128 38 34
Liver dysfunction/failure (clinical) 1 0 1 0 0 0
Lymphopenia 24 31 26 32 15 18
Magnesium, serum-low (hypomagnesemia) 0 0 1 0 0 0
Metabolic/Laboratory-Other 1 0 0 0 0 0
Mood alteration - agitation 1 0 0 0 0 0
Mood alteration - anxiety 1 2 1 0 0 0
Mood alteration - depression 1 6 4 4 1 2
Mucositis/stomatitis (clinical exam) - Anus 0 1 0 1 0 0
Mucositis/stomatitis (clinical exam) - Esophagus 1 0 0 2 0 0
Mucositis/stomatitis (clinical exam) - Oral cavity 17 56 23 57 4 3
Mucositis/stomatitis (clinical exam) - Pharynx 2 5 3 1 0 0
Mucositis/stomatitis (functional/symp) - Anus 0 1 0 0 0 0
Mucositis/stomatitis (functional/symp) - Esophagus 2 3 2 5 1 1
Mucositis/stomatitis (functional/symp) - Oral cav 11 38 28 40 1 6
Mucositis/stomatitis (functional/symp) - Pharynx 4 4 5 4 0 1
Mucositis/stomatitis (functional/symp) - Rectum 1 0 0 0 0 0
Muscle weakness, not d/t neuropathy - Extrem-lower 0 0 0 0 2 1
Muscle weakness, not d/t neuropathy - body/general 0 1 1 2 1 1
Musculoskeletal/Soft Tissue-Other 1 0 0 0 0 0
Myelodysplasia 0 1 1 0 0 0
Myocarditis 0 0 1 0 0 1
Nail changes 4 12 5 9 1 1
Nasal cavity/paranasal sinus reactions 1 0 0 0 0 0
Nausea 50 40 53 33 9 9
Neurology-Other 0 1 0 0 0 0
Neuropathy: CN V Motor-jaw muscles; Sensory-facial 1 0 1 1 0 0
Neuropathy: CN VII Motor-face; Sensory-taste 1 0 0 0 0 1
Neuropathy: cranial - CN VIII Hearing and balance 0 0 0 1 0 0
Neuropathy: cranial - CN XII Motor-tongue 1 0 0 0 0 0
Neuropathy: motor 10 13 8 6 5 8
Neuropathy: sensory 107 101 76 56 45 25
Neutrophils/granulocytes (ANC/AGC) 174 156 218 201 57 65
Obesity 0 0 0 0 1 3
Obstruction, GI - Small bowel NOS 0 1 0 0 0 0
Opportunistic inf associated w/gt=Gr 2 lymphopenia 0 0 1 0 0 0
PTT (Partial thromboplastin time) 0 1 0 0 0 0
Pain - Abdomen NOS 2 3 5 0 5 2
Pain - Anus 1 1 0 0 0 0
Pain - Back 0 5 1 3 2 2
Pain - Bone 10 36 15 9 15 1
Pain - Breast 0 0 0 0 0 2
Pain - Cardiac/heart 1 0 0 1 1 0
Pain - Chest wall 1 0 0 0 1 0
Pain - Chest/thorax NOS 0 1 0 3 0 0
Pain - Dental/teeth/peridontal 0 1 0 0 0 1
Pain - Esophagus 0 0 0 1 0 0
Pain - Extremity-limb 4 9 0 3 4 1
Pain - Head/headache 5 8 10 10 1 0
Pain - Joint 39 40 21 12 11 5
Pain - Kidney 0 0 0 2 0 0
Pain - Middle ear 0 1 0 1 0 0
Pain - Muscle 42 48 21 11 10 5
Pain - Neck 0 1 0 0 0 1
Pain - Neuralgia/peripheral nerve 1 3 2 3 1 0
Pain - Pain NOS 3 0 0 1 0 1
Pain - Pelvis 0 1 0 0 0 0
Pain - Rectum 2 1 0 2 0 0
Pain - Skin 0 1 0 0 0 0
Pain - Stomach 0 0 0 1 0 0
Pain - Uterus 0 0 0 0 1 0
Pain-Other 3 5 2 1 4 0
Pericardial effusion (non-malignant) 0 0 0 0 0 2
Phosphate, serum-low (hypophosphatemia) 0 3 0 2 0 0
Platelets 24 21 20 22 6 2
Pleural effusion (non-malignant) 0 1 1 0 0 1
Pneumonitis/pulmonary infiltrates 8 7 11 5 3 1
Potassium, serum-high (hyperkalemia) 1 1 0 1 0 0
Potassium, serum-low (hypokalemia) 18 12 18 7 8 8
Prolapse of stoma, GI 2 3 2 4 0 0
Proteinuria 0 1 0 0 0 0
Pruritus/itching 2 3 0 1 2 1
Psychosis (hallucinations/delusions) 0 0 1 0 0 0
Pulmonary/Upper Respiratory-Other 1 2 1 0 1 1
Rash/desquamation 4 5 1 4 1 1
Rash: acne/acneiform 0 0 1 0 0 0
Rash: hand-foot skin reaction 19 95 16 94 3 4
Restrictive cardiomyopathy 0 0 1 1 0 0
Right ventricular dysfunction (cor pulmonale) 0 1 0 0 0 0
Rigors/chills 1 0 0 0 0 0
SVT and nodal arrhythmia - Atrial fibrillation 1 1 5 1 0 0
SVT and nodal arrhythmia - SVT tachycardia 0 1 0 0 0 0
SVT and nodal arrhythmia - Sinus tachycardia 0 1 1 0 0 0
Salivary gland changes/saliva 0 1 0 0 0 0
Secondary Malignancy-poss rel to cancer Tx 2 2 4 3 1 0
Seizure 0 1 1 1 0 1
Seroma 0 0 2 0 0 0
Sodium, serum-high (hypernatremia) 1 0 0 0 0 0
Sodium, serum-low (hyponatremia) 7 4 5 4 1 3
Somnolence/depressed level of consciousness 2 1 0 1 0 2
Sudden death 2 0 0 0 0 0
Syncope (fainting) 5 5 7 5 5 7
Syndromes-Other 0 2 1 0 0 0
Taste alteration (dysgeusia) 1 0 2 0 0 0
Thrombosis/embolism (vascular access-related) 9 18 10 6 1 4
Thrombosis/thrombus/embolism 10 7 9 8 3 4
Ulcer, GI - Esophagus 1 0 0 0 0 0
Ulcer, GI - Rectum 0 0 0 0 1 0
Uric acid, serum-high (hyperuricemia) 1 0 0 0 0 0
Urticaria (hives, welts, wheals) 1 0 0 0 0 1
Vaginitis (not due to infection) 0 0 0 1 0 0
Valvular heart disease 1 0 0 0 0 0
Vasovagal episode 0 0 1 0 0 0
Ventricular arrhythmia - PVCs 1 0 0 0 0 0
Ventricular arrhythmia - Ventricular tachycardia 1 1 1 0 0 0
Viral hepatitis 1 0 0 0 0 1
Vision-blurred vision 1 0 1 2 0 0
Voice changes/dysarthria 0 0 0 0 0 1
Vomiting 31 29 38 17 8 6
Watery eye (epiphora, tearing) 0 2 0 0 0 0
Weight loss 2 2 1 1 0 2
Wound complication, non-infectious 0 1 1 0 1 0
4.Secondary Outcome
Title Disease-free Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group
Hide Description Disease-free survival (DFS) defined as time from registration (randomization assignment) to first instance of disease recurrence (local, regional, or distant), new breast primary tumor, or death as a result of any cause. The results are entered as disease free survival at year 5.
Time Frame Biomarkers were measured by gene expression analysis before study entry. DFS were measured every 6 months for 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with HR-positive, HER-2 negative at baseline in each arm were included in this analysis. Arm V and Arm VI were reopened under a new revised protocol and the data were not mature. And the results for Arm V and Arm VI will be reported in a subsequent publication.
Arm/Group Title Arm I Arm II Arm III Arm IV
Hide Arm/Group Description:

(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

Overall Number of Participants Analyzed 375 370 373 362
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
82
(78 to 86)
82
(77 to 86)
86
(82 to 89)
85
(80 to 88)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I, Arm II, Arm III, Arm IV
Comments Overall treatment differences.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm I, Arm II, Arm III, Arm IV
Comments Test of interaction of two treatments: AC and paclitaxel.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.42
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
5.Secondary Outcome
Title Overall Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group
Hide Description Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5.
Time Frame Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with HR-positive, HER-negative at baseline in each arm were included in this analysis. Arm V and Arm VI were reopened under a new revised protocol and the data were not mature. And the results for Arm V and Arm VI will be reported in a subsequent publication.
Arm/Group Title Arm I Arm II Arm III Arm IV
Hide Arm/Group Description:

(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

Overall Number of Participants Analyzed 375 370 373 362
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
91
(87 to 93)
92
(89 to 95)
91
(87 to 94)
90
(86 to 93)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I, Arm II, Arm III, Arm IV
Comments Test of overall treatment differences.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.90
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm I, Arm II, Arm III, Arm IV
Comments Test of interaction of two treatments: AC and paclitaxel.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
6.Secondary Outcome
Title Disease-free Survival Comparison Between 2 Treatments in HR-negative, HER-2 Negative Group
Hide Description Disease-free survival (DFS) defined as time from registration (randomization assignment) to first instance of disease recurrence (local, regional, or distant), new breast primary tumor, or death as a result of any cause. The results are entered as disease free survival at year 5.
Time Frame Biomarkers were measured by gene expression analysis before study entry. DFS was measured every 6 months for 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with HR-negative, HER-2 negative at baseline in each arm were included in this analysis. Arm V and Arm VI were reopened under a new revised protocol and the data were not mature. And the results for Arm V and Arm VI will be reported in a subsequent publication.
Arm/Group Title Arm I Arm II Arm III Arm IV
Hide Arm/Group Description:

(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

Overall Number of Participants Analyzed 153 185 180 162
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
83
(75 to 88)
71
(63 to 77)
72
(64 to 78)
75
(68 to 81)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I, Arm II, Arm III, Arm IV
Comments Test of overall treatment differences.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.076
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm I, Arm II, Arm III, Arm IV
Comments Test of interaction of two treatments: AC and paclitaxel.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
7.Secondary Outcome
Title Overall Survival Comparison Between 2 Treatments in HR-negative, HER-2 Negative Group
Hide Description Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5.
Time Frame Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with HR-negative, HER2-negative at baseline in each arm were included in this analysis. Arm V and Arm VI were reopened under a new revised protocol and the data were not mature. And the results for Arm V and Arm VI will be reported in a subsequent publication.
Arm/Group Title Arm I Arm II Arm III Arm IV
Hide Arm/Group Description:

(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

Overall Number of Participants Analyzed 153 185 180 162
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
85
(78 to 90)
76
(69 to 82)
78
(71 to 84)
82
(75 to 87)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I, Arm II, Arm III, Arm IV
Comments Test of overall treatment differences.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.062
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm I, Arm II, Arm III, Arm IV
Comments Test of interaction of two treatments: AC and paclitaxel.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
8.Secondary Outcome
Title Disease-free Survival Comparison Between 2 Treatments in HER2-positive Group
Hide Description Disease-free survival (DFS) defined as time from registration (randomization assignment) to first instance of disease recurrence (local, regional, or distant), new breast primary tumor, or death as a result of any cause. The results are entered as disease free survival at year 5.
Time Frame Biomarkers were measured by gene expression analysis before study entry. DFS was measured every 6 months for 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with HER2-positive at baseline in each arm were included in this analysis. One patient in Arm II with no follow-up was excluded. Arm V and Arm VI were reopened under a new revised protocol and the data were not mature. And the results for Arm V and Arm VI will be reported in a subsequent publication.
Arm/Group Title Arm I Arm II Arm III Arm IV
Hide Arm/Group Description:

(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

Overall Number of Participants Analyzed 125 122 118 109
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
85
(77 to 90)
83
(74 to 89)
82
(74 to 88)
80
(71 to 87)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I, Arm II, Arm III, Arm IV
Comments Test of overall treatment differences.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm I, Arm II, Arm III, Arm IV
Comments Test of interaction two treatments: AC and paclitaxel.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.66
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
9.Secondary Outcome
Title Overall Survival Comparison Between 2 Treatments in HER-2 Positive Group.
Hide Description Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5.
Time Frame Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with HER2-positive at baseline in each arm were included in this analysis. One patient in Arm II with no follow-up was excluded. Arm V and Arm VI were reopened under a new revised protocol and the data were not mature. And the results for Arm V and Arm VI will be reported in a subsequent publication.
Arm/Group Title Arm I Arm II Arm III Arm IV
Hide Arm/Group Description:

(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.

pegfilgrastim: Given IV

AC regimen: Given IV

cyclophosphamide: Given IV

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

Overall Number of Participants Analyzed 125 122 118 109
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
94
(88 to 97)
89
(81 to 94)
89
(82 to 94)
88
(80 to 93)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I, Arm II, Arm III, Arm IV
Comments Test of overall treatment differences
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.40
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm I, Arm II, Arm III, Arm IV
Comments Test of interaction of two treatments: AC and paclitaxel.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Time Frame Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ARM I ARM II ARM III ARM IV ARM V ARM VI
Hide Arm/Group Description (closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses. (closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I. (closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses. (closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.

Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.

Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.

(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.

Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.

All-Cause Mortality
ARM I ARM II ARM III ARM IV ARM V ARM VI
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
ARM I ARM II ARM III ARM IV ARM V ARM VI
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/654 (1.53%)   8/663 (1.21%)   17/674 (2.52%)   9/624 (1.44%)   5/275 (1.82%)   8/291 (2.75%) 
Blood and lymphatic system disorders             
Blood/Bone Marrow-Other  1  1/654 (0.15%)  0/663 (0.00%)  0/674 (0.00%)  0/624 (0.00%)  0/275 (0.00%)  0/291 (0.00%) 
DIC (disseminated intravascular coagulation)  1  1/654 (0.15%)  0/663 (0.00%)  0/674 (0.00%)  0/624 (0.00%)  0/275 (0.00%)  0/291 (0.00%) 
Febrile neutropenia  1  0/654 (0.00%)  0/663 (0.00%)  0/674 (0.00%)  0/624 (0.00%)  1/275 (0.36%)  2/291 (0.69%) 
Cardiac disorders             
Cardiac-ischemia/infarction  1  0/654 (0.00%)  0/663 (0.00%)  1/674 (0.15%)  0/624 (0.00%)  0/275 (0.00%)  0/291 (0.00%) 
Conduction abnormality - Asystole  1  0/654 (0.00%)  0/663 (0.00%)  1/674 (0.15%)  0/624 (0.00%)  0/275 (0.00%)  0/291 (0.00%) 
Left ventricular diastolic dysfunction  1  1/654 (0.15%)  0/663 (0.00%)  1/674 (0.15%)  0/624 (0.00%)  0/275 (0.00%)  0/291 (0.00%) 
Left ventricular systolic dysfunction  1  1/654 (0.15%)  0/663 (0.00%)  0/674 (0.00%)  0/624 (0.00%)  1/275 (0.36%)  0/291 (0.00%) 
Myocarditis  1  0/654 (0.00%)  0/663 (0.00%)  1/674 (0.15%)  0/624 (0.00%)  0/275 (0.00%)  0/291 (0.00%) 
Pericardial effusion (non-malignant)  1  0/654 (0.00%)  0/663 (0.00%)  0/674 (0.00%)  0/624 (0.00%)  0/275 (0.00%)  1/291 (0.34%) 
Ventricular arrhythmia - PVCs  1  1/654 (0.15%)  0/663 (0.00%)  0/674 (0.00%)  0/624 (0.00%)  0/275 (0.00%)  0/291 (0.00%) 
General disorders             
Constitutional Symptoms-Other  1  0/654 (0.00%)  1/663 (0.15%)  0/674 (0.00%)  0/624 (0.00%)  0/275 (0.00%)  0/291 (0.00%) 
Death - Multi-organ failure  1  1/654 (0.15%)  0/663 (0.00%)  1/674 (0.15%)  0/624 (0.00%)  0/275 (0.00%)  0/291 (0.00%) 
Death not associated with CTCAE term - Death NOS  1  0/654 (0.00%)  0/663 (0.00%)  0/674 (0.00%)  1/624 (0.16%)  0/275 (0.00%)  1/291 (0.34%) 
Hepatobiliary disorders             
Liver dysfunction/failure (clinical)  1  1/654 (0.15%)  0/663 (0.00%)  1/674 (0.15%)  0/624 (0.00%)  0/275 (0.00%)  0/291 (0.00%) 
Infections and infestations             
Inf (clin/microbio) w/Gr 3-4 neuts - Lung  1  1/654 (0.15%)  1/663 (0.15%)  0/674 (0.00%)  2/624 (0.32%)  0/275 (0.00%)  0/291 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Blood  1  1/654 (0.15%)  0/663 (0.00%)  0/674 (0.00%)  0/624 (0.00%)  0/275 (0.00%)  0/291 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Lung  1  0/654 (0.00%)  0/663 (0.00%)  0/674 (0.00%)  1/624 (0.16%)  0/275 (0.00%)  0/291 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Soft tiss  1  0/654 (0.00%)  0/663 (0.00%)  1/674 (0.15%)  0/624 (0.00%)  0/275 (0.00%)  0/291 (0.00%) 
Infection with unknown ANC - Blood  1  0/654 (0.00%)  0/663 (0.00%)  0/674 (0.00%)  0/624 (0.00%)  0/275 (0.00%)  1/291 (0.34%) 
Infection with unknown ANC - Skin (cellulitis)  1  0/654 (0.00%)  0/663 (0.00%)  0/674 (0.00%)  0/624 (0.00%)  0/275 (0.00%)  1/291 (0.34%) 
Injury, poisoning and procedural complications             
Thrombosis/embolism (vascular access-related)  1  0/654 (0.00%)  1/663 (0.15%)  0/674 (0.00%)  0/624 (0.00%)  0/275 (0.00%)  0/291 (0.00%) 
Investigations             
ALT, SGPT (serum glutamic pyruvic transaminase)  1  0/654 (0.00%)  0/663 (0.00%)  2/674 (0.30%)  0/624 (0.00%)  0/275 (0.00%)  0/291 (0.00%) 
AST, SGOT  1  0/654 (0.00%)  0/663 (0.00%)  1/674 (0.15%)  0/624 (0.00%)  0/275 (0.00%)  0/291 (0.00%) 
Bilirubin (hyperbilirubinemia)  1  0/654 (0.00%)  0/663 (0.00%)  1/674 (0.15%)  0/624 (0.00%)  0/275 (0.00%)  0/291 (0.00%) 
Cardiac troponin I (cTnI)  1  0/654 (0.00%)  0/663 (0.00%)  1/674 (0.15%)  0/624 (0.00%)  0/275 (0.00%)  0/291 (0.00%) 
Neutrophils/granulocytes (ANC/AGC)  1  0/654 (0.00%)  0/663 (0.00%)  1/674 (0.15%)  0/624 (0.00%)  3/275 (1.09%)  0/291 (0.00%) 
Metabolism and nutrition disorders             
Potassium, serum-low (hypokalemia)  1  0/654 (0.00%)  0/663 (0.00%)  0/674 (0.00%)  0/624 (0.00%)  0/275 (0.00%)  1/291 (0.34%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Myelodysplasia  1  0/654 (0.00%)  1/663 (0.15%)  1/674 (0.15%)  0/624 (0.00%)  0/275 (0.00%)  0/291 (0.00%) 
Secondary Malignancy-poss rel to cancer Tx  1  2/654 (0.31%)  1/663 (0.15%)  4/674 (0.59%)  3/624 (0.48%)  1/275 (0.36%)  0/291 (0.00%) 
Nervous system disorders             
CNS cerebrovascular ischemia  1  0/654 (0.00%)  0/663 (0.00%)  0/674 (0.00%)  1/624 (0.16%)  0/275 (0.00%)  0/291 (0.00%) 
Seizure  1  0/654 (0.00%)  0/663 (0.00%)  0/674 (0.00%)  0/624 (0.00%)  0/275 (0.00%)  1/291 (0.34%) 
Somnolence/depressed level of consciousness  1  0/654 (0.00%)  0/663 (0.00%)  0/674 (0.00%)  0/624 (0.00%)  0/275 (0.00%)  1/291 (0.34%) 
Psychiatric disorders             
Confusion  1  0/654 (0.00%)  1/663 (0.15%)  0/674 (0.00%)  0/624 (0.00%)  0/275 (0.00%)  0/291 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Adult respiratory distress syndrome (ARDS)  1  1/654 (0.15%)  0/663 (0.00%)  0/674 (0.00%)  0/624 (0.00%)  0/275 (0.00%)  0/291 (0.00%) 
Dyspnea (shortness of breath)  1  0/654 (0.00%)  0/663 (0.00%)  1/674 (0.15%)  0/624 (0.00%)  0/275 (0.00%)  0/291 (0.00%) 
Pleural effusion (non-malignant)  1  0/654 (0.00%)  1/663 (0.15%)  0/674 (0.00%)  0/624 (0.00%)  0/275 (0.00%)  0/291 (0.00%) 
Pneumonitis/pulmonary infiltrates  1  0/654 (0.00%)  0/663 (0.00%)  1/674 (0.15%)  0/624 (0.00%)  0/275 (0.00%)  0/291 (0.00%) 
Pulmonary/Upper Respiratory-Other  1  1/654 (0.15%)  1/663 (0.15%)  1/674 (0.15%)  0/624 (0.00%)  0/275 (0.00%)  0/291 (0.00%) 
Vascular disorders             
Hypotension  1  0/654 (0.00%)  0/663 (0.00%)  1/674 (0.15%)  0/624 (0.00%)  0/275 (0.00%)  0/291 (0.00%) 
Thrombosis/thrombus/embolism  1  1/654 (0.15%)  2/663 (0.30%)  2/674 (0.30%)  1/624 (0.16%)  0/275 (0.00%)  0/291 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ARM I ARM II ARM III ARM IV ARM V ARM VI
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   381/654 (58.26%)   412/663 (62.14%)   389/674 (57.72%)   391/624 (62.66%)   131/275 (47.64%)   126/291 (43.30%) 
Blood and lymphatic system disorders             
Febrile neutropenia  1  49/654 (7.49%)  9/663 (1.36%)  38/674 (5.64%)  20/624 (3.21%)  15/275 (5.45%)  12/291 (4.12%) 
Hemoglobin  1  87/654 (13.30%)  48/663 (7.24%)  101/674 (14.99%)  47/624 (7.53%)  21/275 (7.64%)  19/291 (6.53%) 
Gastrointestinal disorders             
Mucositis/stomatitis (clinical exam) - Oral cavity  1  17/654 (2.60%)  56/663 (8.45%)  23/674 (3.41%)  57/624 (9.13%)  4/275 (1.45%)  3/291 (1.03%) 
Mucositis/stomatitis (functional/symp) - Oral cav  1  11/654 (1.68%)  38/663 (5.73%)  28/674 (4.15%)  40/624 (6.41%)  1/275 (0.36%)  6/291 (2.06%) 
Nausea  1  50/654 (7.65%)  40/663 (6.03%)  53/674 (7.86%)  33/624 (5.29%)  9/275 (3.27%)  9/291 (3.09%) 
Vomiting  1  31/654 (4.74%)  29/663 (4.37%)  38/674 (5.64%)  17/624 (2.72%)  8/275 (2.91%)  6/291 (2.06%) 
General disorders             
Fatigue (asthenia, lethargy, malaise)  1  77/654 (11.77%)  59/663 (8.90%)  87/674 (12.91%)  65/624 (10.42%)  20/275 (7.27%)  14/291 (4.81%) 
Investigations             
Leukocytes (total WBC)  1  128/654 (19.57%)  98/663 (14.78%)  157/674 (23.29%)  128/624 (20.51%)  38/275 (13.82%)  34/291 (11.68%) 
Lymphopenia  1  24/654 (3.67%)  31/663 (4.68%)  26/674 (3.86%)  32/624 (5.13%)  15/275 (5.45%)  18/291 (6.19%) 
Neutrophils/granulocytes (ANC/AGC)  1  174/654 (26.61%)  156/663 (23.53%)  217/674 (32.20%)  201/624 (32.21%)  54/275 (19.64%)  65/291 (22.34%) 
Musculoskeletal and connective tissue disorders             
Pain - Bone  1  10/654 (1.53%)  36/663 (5.43%)  15/674 (2.23%)  9/624 (1.44%)  15/275 (5.45%)  1/291 (0.34%) 
Pain - Joint  1  39/654 (5.96%)  40/663 (6.03%)  21/674 (3.12%)  12/624 (1.92%)  11/275 (4.00%)  5/291 (1.72%) 
Pain - Muscle  1  42/654 (6.42%)  48/663 (7.24%)  21/674 (3.12%)  11/624 (1.76%)  10/275 (3.64%)  5/291 (1.72%) 
Nervous system disorders             
Neuropathy: sensory  1  107/654 (16.36%)  101/663 (15.23%)  76/674 (11.28%)  56/624 (8.97%)  45/275 (16.36%)  25/291 (8.59%) 
Skin and subcutaneous tissue disorders             
Rash: hand-foot skin reaction  1  19/654 (2.91%)  95/663 (14.33%)  16/674 (2.37%)  94/624 (15.06%)  3/275 (1.09%)  4/291 (1.37%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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: Breast Committee Statistician
Organization: SWOG Statistical Center
Phone: 206-667-4623
EMail: jmiao@fredhutch.org
Layout table for additonal information
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00070564    
Other Study ID Numbers: CDR0000334899
S0221 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: October 3, 2003
First Posted: October 7, 2003
Results First Submitted: January 9, 2017
Results First Posted: April 17, 2017
Last Update Posted: December 30, 2019