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Type(s) of Cancer
Breast
Study Phase
Phase 3
Study Completion Date
April 2012
NCT00041119Uploaded 07-28-2017
Available for Download
PDS UID: Breast_Allianc_2002_200
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 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 SubsetN/A
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 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:
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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