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Combination Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA (cT1-3, N0-1, M0) Breast Cancer and Positive Axillary Lymph Nodes

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: NCT00003782
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : October 31, 2012
Last Update Posted : January 18, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
NSABP Foundation Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: cyclophosphamide
Drug: docetaxel
Drug: doxorubicin
Enrollment 5351
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1: Doxorubicin + Cyclophosphamide, Then Docetaxel Arm 2: Doxorubicin + Docetaxel Arm 3: Doxorubicin + Docetaxel + Cyclophosphamide
Hide Arm/Group Description Doxorubicin + Cyclophosphamide, then Docetaxel Doxorubicin + Docetaxel Doxorubicin + Docetaxel + Cyclophosphamide
Period Title: Overall Study
Started 1783 1784 1784
Completed 1753 1753 1758
Not Completed 30 31 26
Reason Not Completed
No follow up data             30             31             26
Arm/Group Title Doxorubicin + Cyclophosphamide, Then Docetaxel Doxorubicin + Docetaxel Doxorubicin + Docetaxel + Cyclophosphamide Total
Hide Arm/Group Description Doxorubicin + Cyclophosphamide, then Docetaxel Doxorubicin + Docetaxel Doxorubicin + Docetaxel + Cyclophosphamide Total of all reporting groups
Overall Number of Baseline Participants 1783 1784 1784 5351
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1783 participants 1784 participants 1784 participants 5351 participants
50  (9.8) 50  (9.5) 51  (9.9) 51  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1783 participants 1784 participants 1784 participants 5351 participants
Female
1783
 100.0%
1784
 100.0%
1784
 100.0%
5351
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame 8 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Doxorubicin + Cyclophosphamide, Then Docetaxel Arm 2: Doxorubicin + Docetaxel Arm 3: Doxorubicin + Docetaxel + Cyclophosphamide
Hide Arm/Group Description:
Doxorubicin + Cyclophosphamide, then Docetaxel
Doxorubicin + Docetaxel
Doxorubicin + Docetaxel + Cyclophosphamide
Overall Number of Participants Analyzed 1753 1753 1758
Measure Type: Number
Unit of Measure: percentage of patients alive
83 79 79
2.Primary Outcome
Title Disease Free Survival
Hide Description [Not Specified]
Time Frame time to event: breast cancer recurrence; second primary cancer; death from any cause as a first event
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Toxicities Among the 3 Regimens
Hide Description [Not Specified]
Time Frame 9 years
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Quality of Life Among Breast Cancer Patients
Hide Description [Not Specified]
Time Frame baseline, 9 weeks, and 6, 12, 18, and 24 months
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Amenorrhea in Premenopausal Women
Hide Description [Not Specified]
Time Frame baseline, 9 weeks, and 6, 12, 18, and 24 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description Participants at Risk includes any patient who submitted an AE form.
 
Arm/Group Title Doxorubicin + Cyclophosphamide, Then Docetaxel Doxorubicin + Docetaxel Doxorubicin + Docetaxel + Cyclophosphamide
Hide Arm/Group Description Doxorubicin + Cyclophosphamide, then Docetaxel Doxorubicin + Docetaxel Doxorubicin + Docetaxel + Cyclophosphamide
All-Cause Mortality
Doxorubicin + Cyclophosphamide, Then Docetaxel Doxorubicin + Docetaxel Doxorubicin + Docetaxel + Cyclophosphamide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Doxorubicin + Cyclophosphamide, Then Docetaxel Doxorubicin + Docetaxel Doxorubicin + Docetaxel + Cyclophosphamide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   66/1748 (3.78%)   43/1748 (2.46%)   46/1745 (2.64%) 
Blood and lymphatic system disorders       
Febrile neutropenia  1  2/1748 (0.11%)  1/1748 (0.06%)  7/1745 (0.40%) 
Cardiac disorders       
Cardiac disorders - Other, specify  1  3/1748 (0.17%)  1/1748 (0.06%)  1/1745 (0.06%) 
Conduction disorder  1  0/1748 (0.00%)  0/1748 (0.00%)  1/1745 (0.06%) 
Myocardial infarction  1  0/1748 (0.00%)  1/1748 (0.06%)  0/1745 (0.00%) 
Ventricular arrhythmia  1  1/1748 (0.06%)  0/1748 (0.00%)  1/1745 (0.06%) 
Left ventricular systolic dysfunction  1  0/1748 (0.00%)  1/1748 (0.06%)  1/1745 (0.06%) 
Gastrointestinal disorders       
Colitis  1  1/1748 (0.06%)  1/1748 (0.06%)  2/1745 (0.11%) 
Diarrhea  1  0/1748 (0.00%)  1/1748 (0.06%)  1/1745 (0.06%) 
Duodenal ulcer  1  0/1748 (0.00%)  1/1748 (0.06%)  0/1745 (0.00%) 
Esophagitis  1  0/1748 (0.00%)  1/1748 (0.06%)  0/1745 (0.00%) 
Gastrointestinal disorders - Other, specify  1  1/1748 (0.06%)  0/1748 (0.00%)  1/1745 (0.06%) 
Mucositis oral  1  0/1748 (0.00%)  1/1748 (0.06%)  0/1745 (0.00%) 
Typhlitis  1  1/1748 (0.06%)  3/1748 (0.17%)  1/1745 (0.06%) 
Vomiting  1  2/1748 (0.11%)  1/1748 (0.06%)  0/1745 (0.00%) 
General disorders       
General disorders and administration site conditions - Other, specify  1  0/1748 (0.00%)  0/1748 (0.00%)  1/1745 (0.06%) 
Hepatobiliary disorders       
Hepatic failure  1  0/1748 (0.00%)  1/1748 (0.06%)  0/1745 (0.00%) 
Hepatobiliary disorders - Other, specify  1  0/1748 (0.00%)  0/1748 (0.00%)  1/1745 (0.06%) 
Immune system disorders       
Anaphylaxis  1  1/1748 (0.06%)  3/1748 (0.17%)  0/1745 (0.00%) 
Infections and infestations       
Infections and infestations - Other, specify  1  9/1748 (0.51%)  7/1748 (0.40%)  10/1745 (0.57%) 
Wound infection  1  1/1748 (0.06%)  1/1748 (0.06%)  0/1745 (0.00%) 
Injury, poisoning and procedural complications       
Dermatitis radiation  1  0/1748 (0.00%)  0/1748 (0.00%)  2/1745 (0.11%) 
Investigations       
Alanine aminotransferase increased (ALT/SGPT)  1  1/1748 (0.06%)  0/1748 (0.00%)  1/1745 (0.06%) 
Aspartate aminotransferase increased (AST/SGOT)  1  1/1748 (0.06%)  1/1748 (0.06%)  2/1745 (0.11%) 
Blood bilirubin increased  1  0/1748 (0.00%)  0/1748 (0.00%)  1/1745 (0.06%) 
Creatinine increased  1  1/1748 (0.06%)  1/1748 (0.06%)  0/1745 (0.00%) 
Neutrophil count decreased  1  1/1748 (0.06%)  0/1748 (0.00%)  0/1745 (0.00%) 
White blood cell decreased  1  1/1748 (0.06%)  0/1748 (0.00%)  0/1745 (0.00%) 
Metabolism and nutrition disorders       
Anorexia  1  0/1748 (0.00%)  2/1748 (0.11%)  1/1745 (0.06%) 
Dehydration  1  2/1748 (0.11%)  0/1748 (0.00%)  2/1745 (0.11%) 
Hyperglycemia  1  14/1748 (0.80%)  5/1748 (0.29%)  2/1745 (0.11%) 
Hypertriglyceridemia  1  1/1748 (0.06%)  0/1748 (0.00%)  0/1745 (0.00%) 
Hypocalcemia  1  0/1748 (0.00%)  1/1748 (0.06%)  0/1745 (0.00%) 
Hypokalemia  1  1/1748 (0.06%)  0/1748 (0.00%)  1/1745 (0.06%) 
Hyponatremia  1  0/1748 (0.00%)  1/1748 (0.06%)  1/1745 (0.06%) 
Musculoskeletal and connective tissue disorders       
Musculoskeletal and connective tissue disorder - Other, specify  1  1/1748 (0.06%)  0/1748 (0.00%)  0/1745 (0.00%) 
Nervous system disorders       
Intracranial hemorrhage  1  0/1748 (0.00%)  1/1748 (0.06%)  0/1745 (0.00%) 
Nervous system disorders - Other, specify  1  2/1748 (0.11%)  4/1748 (0.23%)  2/1745 (0.11%) 
Peripheral motor neuropathy  1  2/1748 (0.11%)  0/1748 (0.00%)  0/1745 (0.00%) 
Vasovagal reaction  1  0/1748 (0.00%)  0/1748 (0.00%)  1/1745 (0.06%) 
Psychiatric disorders       
Anxiety  1  1/1748 (0.06%)  0/1748 (0.00%)  1/1745 (0.06%) 
Confusion  1  2/1748 (0.11%)  0/1748 (0.00%)  0/1745 (0.00%) 
Depression  1  5/1748 (0.29%)  6/1748 (0.34%)  2/1745 (0.11%) 
Psychosis  1  1/1748 (0.06%)  0/1748 (0.00%)  0/1745 (0.00%) 
Renal and urinary disorders       
Hematuria  1  0/1748 (0.00%)  0/1748 (0.00%)  1/1745 (0.06%) 
Urinary tract obstruction  1  1/1748 (0.06%)  0/1748 (0.00%)  0/1745 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Adult respiratory distress syndrome  1  2/1748 (0.11%)  0/1748 (0.00%)  0/1745 (0.00%) 
Dyspnea  1  6/1748 (0.34%)  0/1748 (0.00%)  3/1745 (0.17%) 
Hypoxia  1  1/1748 (0.06%)  1/1748 (0.06%)  0/1745 (0.00%) 
Pneumonitis  1  1/1748 (0.06%)  0/1748 (0.00%)  0/1745 (0.00%) 
Respiratory, thoracic and mediastinal disorders - Other, specify  1  1/1748 (0.06%)  0/1748 (0.00%)  0/1745 (0.00%) 
Skin and subcutaneous tissue disorders       
Stevens-Johnson syndrome  1  1/1748 (0.06%)  0/1748 (0.00%)  0/1745 (0.00%) 
Vascular disorders       
Capillary leak syndrome  1  0/1748 (0.00%)  0/1748 (0.00%)  1/1745 (0.06%) 
Hypertension  1  1/1748 (0.06%)  0/1748 (0.00%)  0/1745 (0.00%) 
Hypotension  1  1/1748 (0.06%)  1/1748 (0.06%)  0/1745 (0.00%) 
Thromboembolic event  1  12/1748 (0.69%)  4/1748 (0.23%)  8/1745 (0.46%) 
Visceral arterial ischemia  1  0/1748 (0.00%)  0/1748 (0.00%)  2/1745 (0.11%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE v4.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Doxorubicin + Cyclophosphamide, Then Docetaxel Doxorubicin + Docetaxel Doxorubicin + Docetaxel + Cyclophosphamide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   845/1748 (48.34%)   561/1748 (32.09%)   641/1745 (36.73%) 
Blood and lymphatic system disorders       
Febrile neutropenia  1  383/1748 (21.91%)  223/1748 (12.76%)  275/1745 (15.76%) 
Gastrointestinal disorders       
Diarrhea  1  78/1748 (4.46%)  66/1748 (3.78%)  111/1745 (6.36%) 
Nausea  1  162/1748 (9.27%)  127/1748 (7.27%)  155/1745 (8.88%) 
Vomiting  1  140/1748 (8.01%)  90/1748 (5.15%)  119/1745 (6.82%) 
General disorders       
Fatigue  1  212/1748 (12.13%)  135/1748 (7.72%)  167/1745 (9.57%) 
Infections and infestations       
Infections and infestations - Other, specify  1  200/1748 (11.44%)  144/1748 (8.24%)  137/1745 (7.85%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  126/1748 (7.21%)  22/1748 (1.26%)  33/1745 (1.89%) 
Myalgia  1  148/1748 (8.47%)  29/1748 (1.66%)  35/1745 (2.01%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE v4.0
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: Director, Division of Regulatory Affairs
Organization: NSABP Foundation, Inc.
Phone: 412-330-4600
Publications of Results:
Ganz PA, Land SR, Geyer CE, et al.: NSABP B-30: definitive analysis of quality of life (QOL) and menstrual history (MH) outcomes from a randomized trial evaluating different schedules and combinations of adjuvant therapy containing doxorubicin, docetaxel and cyclophosphamide in women with operable, node-positive breast cancer. [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-76, 2008.
Swain SM, Jeong JH, Geyer CE, et al.: NSABP B-30: definitive analysis of patient outcome from a randomized trial evaluating different schedules and combinations of adjuvant therapy containing doxorubicin, docetaxel and cyclophosphamide in women with operable, node-positive breast cancer. [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-75, 2008.
Swain SM, Land SR, Sundry R, et al.: Amenorrhea in premenopausal women on the doxorubicin (A) and cyclophosphamide (C) followed-by docetaxel (T) arm of NSABP B-30: preliminary results. [Abstract] J Clin Oncol 23 (Suppl 16): A-537, 13s, 2005.
Layout table for additonal information
Responsible Party: NSABP Foundation Inc
ClinicalTrials.gov Identifier: NCT00003782    
Other Study ID Numbers: NSABP B-30
CDR0000066914
First Submitted: November 1, 1999
First Posted: January 27, 2003
Results First Submitted: August 24, 2012
Results First Posted: October 31, 2012
Last Update Posted: January 18, 2013