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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00070564
First Posted: October 7, 2003
Last Update Posted: April 17, 2017
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
Results First Submitted: January 9, 2017  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The interaction of the doxorubicin- cyclophosphamide and paclitaxel factors was found to be significant (P = 0.024), thus the two factors could not be analyzed separately. The analysis was therefore limited to patients participated in Arm I to Arm IV. Information of Arm V, Arm VI were still present in Participant Flow.

Reporting Groups
  Description
Arm I

(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

Arm II

(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

Arm III

(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

Arm 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

Arm V

(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.

Arm VI

(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.


Participant Flow:   Overall Study
    Arm I   Arm II   Arm III   Arm IV   Arm V   Arm VI
STARTED   678   693   697   648   282   296 
COMPLETED   478   490   526   481   203   244 
NOT COMPLETED   200   203   171   167   79   52 
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 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only eligible and analyzable patients were included in the analysis.

Reporting Groups
  Description
Arm I

(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

Arm II

(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

Arm III

(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

Arm 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

Total Total of all reporting groups

Baseline Measures
   Arm I   Arm II   Arm III   Arm IV   Total 
Overall Participants Analyzed 
[Units: Participants]
 664   683   681   639   2667 
Age 
[Units: Years]
Median (Full Range)
         
Participants Analyzed 
[Units: Participants]
 664   683   681   639   2667 
   50.5 
 (25 to 77) 
 50.9 
 (23 to 79) 
 51.8 
 (23 to 86) 
 50.7 
 (21 to 76) 
 51.0 
 (21 to 86) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Participants Analyzed 
[Units: Participants]
 664   683   681   639   2667 
Female      658  99.1%      679  99.4%      676  99.3%      636  99.5%      2649  99.3% 
Male      6   0.9%      4   0.6%      5   0.7%      3   0.5%      18   0.7% 
Black Race 
[Units: Participants]
Count of Participants
         
Participants Analyzed 
[Units: Participants]
 664   683   681   639   2667 
   73   77   74   78   302 
Menopausal status (females) [1] 
[Units: Participants]
Count of Participants
         
Participants Analyzed 
[Units: Participants]
 658   679   676   636   2649 
Premenopausal      326  49.5%      325  47.9%      308  45.6%      299  47.0%      1258  47.5% 
Postmenopausal      332  50.5%      354  52.1%      368  54.4%      337  53.0%      1391  52.5% 
[1] Only females of the total eligible and analyzable patients were included in menopausal status measurement.
Nodal status 
[Units: Participants]
Count of Participants
         
Participants Analyzed 
[Units: Participants]
 664   683   681   639   2667 
Negative      161  24.2%      153  22.4%      159  23.3%      146  22.8%      619  23.2% 
1-3 positive nodes      260  39.2%      266  38.9%      276  40.5%      245  38.3%      1047  39.3% 
>= 4 positive nodes      241  36.3%      264  38.7%      243  35.7%      244  38.2%      992  37.2% 
unknown      2   0.3%      0   0.0%      3   0.4%      4   0.6%      9   0.3% 
ER/PgR [1] 
[Units: Participants]
Count of Participants
         
Participants Analyzed 
[Units: Participants]
 664   683   681   639   2667 
Negative (both negative)      212  31.9%      226  33.1%      232  34.1%      206  32.2%      876  32.8% 
Positive (either or both positive)      450  67.8%      456  66.8%      446  65.5%      430  67.3%      1782  66.8% 
Unknown      2   0.3%      1   0.1%      3   0.4%      3   0.5%      9   0.3% 
[1] ER, estrogen receptor; PgR, progesterone receptor
HER2 [1] 
[Units: Participants]
Count of Participants
         
Participants Analyzed 
[Units: Participants]
 664   683   681   639   2667 
Negative      528  79.5%      556  81.4%      554  81.4%      525  82.2%      2163  81.1% 
Positive      125  18.8%      123  18.0%      118  17.3%      109  17.1%      475  17.8% 
Unknown      11   1.7%      4   0.6%      9   1.3%      5   0.8%      29   1.1% 
[1] HER2, human epidermal growth factor receptor 2.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Disease-free Survival   [ Time Frame: every 6 months (annually for mammograms) for 5 years ]

2.  Primary:   Overall Survival   [ Time Frame: Every 6 months for 5 years ]

3.  Secondary:   Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs   [ Time Frame: Toxicity assessment was evaluated every 4 weeks while on protocol therapy. ]

4.  Secondary:   Disease-free Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group   [ Time Frame: Biomarkers were measured by gene expression analysis before study entry. DFS were measured every 6 months for 5 years ]

5.  Secondary:   Overall Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group   [ Time Frame: Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 years ]

6.  Secondary:   Disease-free Survival Comparison Between 2 Treatments in HR-negative, HER-2 Negative Group   [ Time Frame: Biomarkers were measured by gene expression analysis before study entry. DFS was measured every 6 months for 5 years ]

7.  Secondary:   Overall Survival Comparison Between 2 Treatments in HR-negative, HER-2 Negative Group   [ Time Frame: Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 years ]

8.  Secondary:   Disease-free Survival Comparison Between 2 Treatments in HER2-positive Group   [ Time Frame: Biomarkers were measured by gene expression analysis before study entry. DFS was measured every 6 months for 5 years ]

9.  Secondary:   Overall Survival Comparison Between 2 Treatments in HER-2 Positive Group.   [ Time Frame: Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Breast Committee Statistician
Organization: SWOG Statistical Center
phone: 206-667-4623
e-mail: jmiao@fredhutch.org


Publications of Results:

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00070564     History of Changes
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: April 17, 2017