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Breast

CALGB 9741: A Randomized Phase III Trial of Sequential Chemotherapy Using Doxorubicin, Paclitaxel, and Cyclophosphamide or Concurrent Doxorubicin and Cyclophosphamide Followed by Paclitaxel at 14 or 21 Day Intervals in Women With Node Positive Stage II/IIIA Breast Cancer

Unique Data Set IDBreast_Allianc_1997_180
DownloadableYes
SponsorAlliance for Clinical Trials in OncologyData ProviderAlliance for Clinical Trials in OncologyTotal Study Enrolled Patients2005Comparator (Control) Arm Enrolled Patients0Experimental (Active) Arm Enrolled Patients1973RandomizationYesClinicalTrial.gov IDNCT00003088ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00003088
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataBoth comparator and experimental arm dataIntervention TypeChemotherapyData Set TypeADS

Clinical Trial Title

CALGB 9741: A Randomized Phase III Trial of Sequential Chemotherapy Using Doxorubicin, Paclitaxel, and Cyclophosphamide or Concurrent Doxorubicin and Cyclophosphamide Followed by Paclitaxel at 14 or 21 Day Intervals in Women With Node Positive Stage II/IIIA Breast Cancer

Trial Summary and Conditions

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs at different times or combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy consisting of either doxorubicin, cyclophosphamide, or paclitaxel given at different times with that of combination chemotherapy consisting of doxorubicin plus cyclophosphamide followed by paclitaxel in treating women with stage II or stage IIIA breast cancer.

Data Summary

Control and experimental arm data files include data on efficacy, demographics, etc. See the data dictionary provided for more details.

Study Objectives

OBJECTIVES: I. Compare the sequential chemotherapy with doxorubicin, paclitaxel and cyclophosphamide to combined doxorubicin and cyclophosphamide followed by paclitaxel for disease free and overall survival in women with node positive stage II or IIIA breast cancer. II. Determine whether increasing the dose density of adjuvant chemotherapy will improve disease free and overall survival. III. Compare the toxicity in patients treated with these regimens.

Outcome Measures

Primary Outcome Measure: Disease free survival

Available Downloads:

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

PROTOCOL: 9741_protocol.pdf

CRF: 9741_CRF.pdf

DATA DICTIONARY: 9741_datadictionary.pdf

DATA (ACTIVE ARM): dosered.csv

DATA (ACTIVE ARM): comp_by_pt.csv

DATA (ACTIVE ARM): comp_by_cyc.csv

DATA (ACTIVE ARM): treated.csv

DATA (ACTIVE ARM): toxicity.csv