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Breast

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

Unique Data Set IDBreast_Allianc_2002_194
DownloadableYes
SponsorAlliance for Clinical Trials in OncologyData ProviderThe Alliance for Clinical Trials in OncologyTotal Study Enrolled Patients3871Comparator (Control) Arm Enrolled Patients1142Experimental (Active) Arm Enrolled Patients2729RandomizationYesClinicalTrial.gov IDNCT00041119ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/study/NCT00041119?term=CALGB+40101&rank=1&view=record
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataBoth comparator and experimental arm dataIntervention TypeChemotherapyData Set TypeADS

Clinical Trial Title

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

Trial Summary and Conditions

This 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

Data Summary

Control and experimental arms include raw data on safety, efficacy, and demographics

Study Objectives

-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.

Outcome Measures

1. Comparing therapy length with regard to relapse free survival. 2. 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). 3. 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. 4. To determine the effect of long and short course CA and paclitaxel on the induction of menopause for pre-menopausal patients.

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: 40101-10.pdf

CRF: CALGB40101_CRF.pdf

DATA DICTIONARY: data_dictionary_40101a.docx

DATA (BOTH COMPARATOR AND ACTIVE ARMS): eval46_3_finala.sas7bdat

DATA (BOTH COMPARATOR AND ACTIVE ARMS): aeclean_finala.sas7bdat