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Type(s) of Cancer
Breast
Study Phase
Phase 3
Study Completion Date
April 2012
NCT00041119Uploaded 12-31-2021
Access via NCI by Request
PDS UID: nci-data-486
Cyclophosphamide And Doxorubicin (CA) (4 VS 6 Cycles) Versus Paclitaxel (4 VS 6 Cycles) As Adjuvant Therapy For Breast Cancer in Women With 0-3 Positive Axillary Lymph Nodes:A 2X2 Factorial Phase III Randomized Study
Provider Information
Provider Data DescriptionThe NCT00041119_D1_(FactorA_Patients) dataset is one of 2 datasets associated with PubMed ID 22826271. This dataset contains de-identified patient-level information. The information includes baseline characteristics, eligibility, and endpoint data.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies cyclophosphamide and doxorubicin hydrochloride compared with paclitaxel as adjuvant therapy in treating breast cancer in women with 0-3 positive axillary lymph nodes. Giving additional cancer treatment after surgery may help to lower the risk that the cancer will come back (adjuvant therapy). Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether the standard adjuvant therapy of cyclophosphamide and doxorubicin hydrochloride is more effective than paclitaxel in treating women with breast cancer
ConditionsBreast Cancer
Intervention TypeDrug: AC regimen
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: paclitaxel
Drug(s)Drug: AC regimen
Drug: doxorubicin hydrochloride
Drug: cyclophosphamide
Drug: paclitaxel
Total Enrolled3871
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm I (CA for 4 courses) - Active Comparator
Arm II (CA for 6 courses [closed to accrual 12/15/2007]) - Experimental
Arm III (paclitaxel for 4 courses) - Experimental
Arm IV (paclitaxel for 6 courses [closed 12/15/2007]) - Experimental
Secondary IDCDR0000069444
PubMed (PMID)22843789
22826271
30409792
24934787
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
South Africa
Age Range18 Years and older (Adult, Older Adult)
Files: NCT00041119-D1
Data DictionaryNCT00041119-D1-Data-Dictionary_0.pdf
DATANCT00041119-D1-Dataset_0.csv
OTHERREADME.pdf
Files: NCT00041119-D2
Data DictionaryNCT00041119-D2-Data-Dictionary_0.pdf
DATANCT00041119-D2-Dataset_0.csv
OTHERREADME.pdf
Files: NCT00041119-D3
Data DictionaryNCT00041119-D3-Data-Dictionary_0.pdf
DATANCT00041119-D3-Dataset_0.csv
OTHERREADME.pdf
Files: NCT00041119-D4
Data DictionaryNCT00041119-D4-Data-Dictionary_0.pdf
DATANCT00041119-D4-Dataset_0.csv
OTHERREADME.pdf
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