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Type(s) of Cancer
Breast
Study Phase
Phase 3
Study Completion Date
2002
NCT00041119Uploaded 07-20-2017
Available for Download
PDS UID: Breast_Allianc_2002_194
N/A
Provider Information
Provider Data Description-To determine the equivalence of paclitaxel given every two weeks as adjuvant therapy for women with 0-3 positive axillary lymph nodes, for disease-free survival. -To determine the potential superiority of longer vs. shorter therapy, in relation to overall survival, local control and time to distant metastases. -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/10.34949/290c-k254
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
CRFCALGB40101_CRF.pdf
DATA DICTIONARYdata_dictionary_40101a.docx
DATA (BOTH COMPARATOR AND ACTIVE ARMS)eval46_3_finala.sas7bdat
DATA (BOTH COMPARATOR AND ACTIVE ARMS)aeclean_finala.sas7bdat
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