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 : March 21, 2024

View this study on the modernized ClinicalTrials.gov

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

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Arm 1: Doxorubicin + Cyclophosphamide, Then Docetaxel	Arm 2: Doxorubicin + Docetaxel	Arm 3: Doxorubicin + Docetaxel + Cyclophosphamide
Arm/Group Description	Doxorubicin + Cyclophosphamide, the...	Doxorubicin + Docetaxel	Doxorubicin + Docetaxel + Cyclophos...
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

Baseline Characteristics

Arm/Group Title		Doxorubicin + Cyclophosphamide, Then Docetaxel	Doxorubicin + Docetaxel	Doxorubicin + Docetaxel + Cyclophosphamide	Total
Arm/Group Description		Doxorubicin + Cyclophosphamide, the...	Doxorubicin + Docetaxel	Doxorubicin + Docetaxel + Cyclophos...	Total of all reporting groups
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
Baseline Analysis Population Description		[Not Specified]
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%

Outcome Measures

1.Primary Outcome


Title	Overall Survival
Description	[Not Specified]
Description	[Not Specified]
Time Frame	8 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Arm 1: Doxorubicin + Cyclophosphamide, Then Docetaxel	Arm 2: Doxorubicin + Docetaxel	Arm 3: Doxorubicin + Docetaxel + Cyclophosphamide
Arm/Group Description:	Doxorubicin + Cyclophosphamide, the...	Doxorubicin + Docetaxel	Doxorubicin + Docetaxel + Cyclophos...
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
Description	[Not Specified]
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
Description	[Not Specified]
Description	[Not Specified]
Time Frame	9 years

Outcome Measure Data Not Reported

4.Secondary Outcome


Title	Quality of Life Among Breast Cancer Patients
Description	[Not Specified]
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
Description	[Not Specified]
Description	[Not Specified]
Time Frame	baseline, 9 weeks, and 6, 12, 18, and 24 months

Outcome Measure Data Not Reported

Adverse Events

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
Arm/Group Description	Doxorubicin + Cyclophosphamide, the...	Doxorubicin + Docetaxel	Doxorubicin + Docetaxel + Cyclophos...
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	--/--	--/--	--/--
Serious Adverse Events 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
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

Limitations and Caveats

[Not Specified]

More Information

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:

Swain SM, Land SR, Ritter MW, Costantino JP, Cecchini RS, Mamounas EP, Wolmark N, Ganz PA. Amenorrhea in premenopausal women on the doxorubicin-and-cyclophosphamide-followed-by-docetaxel arm of NSABP B-30 trial. Breast Cancer Res Treat. 2009 Jan;113(2):315-20. doi: 10.1007/s10549-008-9937-0. Epub 2008 Feb 27.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bandos H, Melnikow J, Rivera DR, Swain SM, Sturtz K, Fehrenbacher L, Wade JL 3rd, Brufsky AM, Julian TB, Margolese RG, McCarron EC, Ganz PA. Long-term Peripheral Neuropathy in Breast Cancer Patients Treated With Adjuvant Chemotherapy: NRG Oncology/NSABP B-30. J Natl Cancer Inst. 2018 Feb 1;110(2):djx162. doi: 10.1093/jnci/djx162.

Swain SM, Jeong JH, Geyer CE Jr, Costantino JP, Pajon ER, Fehrenbacher L, Atkins JN, Polikoff J, Vogel VG, Erban JK, Rastogi P, Livingston RB, Perez EA, Mamounas EP, Land SR, Ganz PA, Wolmark N. Longer therapy, iatrogenic amenorrhea, and survival in early breast cancer. N Engl J Med. 2010 Jun 3;362(22):2053-65. doi: 10.1056/NEJMoa0909638.

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:	March 21, 2024

To Top