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Type(s) of Cancer
Breast
Study Phase
Phase 3
Study Completion Date
2002
NCT00041119Uploaded 07-28-2017
Available for Download
PDS UID: Breast_Allianc_2002_200
N/A
Provider Information
Provider Data DescriptionTo determine the equivalence of paclitaxel given every two weeks with cyclophosphamide and doxorubicin hydrochloride (CA) given every two weeks as adjuvant therapy for women with 0-3 positive axillary lymph nodes, for disease-free survival. To determine if longer therapy, 12 weeks, is superior to shorter therapy, 8 weeks, of either CA or paclitaxel for disease-free survival for women with primary breast cancer with 0-3 positive axillary lymph nodes. To determine the equivalence of paclitaxel given every two weeks with CA given every two weeks, and the potential superiority of longer vs. shorter therapy, in relation to overall survival, local control (regardless of metastatic status) and time to distant metastases (regardless of local recurrence status). To compare toxicities of short and long course CA and paclitaxel as adjuvant therapy for women with 0-3 positive axillary lymph node breast cancer. To determine the effect of long and short course CA and paclitaxel on the induction of menopause for pre-menopausal patients.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderAlliance for Clinical Trials in Oncology
Partial set or SubsetOriginal Data
Patients in dataset3871
# of Patients Control1142
# of Patients Experimental2729
DOIhttps://doi.org/10.34949/ksa0-vq66
CDISC StandardADS
Study ArmsBoth comparator and experimental arm data
Clinical Trials.gov Information
Brief SummaryN/A
ConditionsN/A
Intervention TypeChemotherapy
Drug(s)N/A
Total EnrolledN/A
RandomizationN/A
Blinding MethodN/A
Arms InterventionN/A
Secondary IDN/A
PubMed (PMID)N/A
Collaborator(s)N/A
Region(s)N/A
Age RangeN/A
Files:
PROTOCOL40101-10.pdf
CRF40101_Annotated_CRFs.pdf
DATA DICTIONARYdata_dictionary_40101b.docx
DATA (ACTIVE ARM)all_finalb.sas7bdat
DATA (ACTIVE ARM)aeclean_finalb.sas7bdat
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