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Type(s) of Cancer
Breast
Study Phase
Phase 3
Study Completion Date
April 2003
NCT00003088Uploaded 08-24-2017
Access via NCI by Request
PDS UID: nci-data-363
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
Provider Information
Provider Data DescriptionThe NCT00003088_D10_(treated) dataset is one of 5 datasets associated with PubMed ID 12668651. This dataset contains one record for treated patients only (N=1973). The dataset contains the primary and secondary endpoint survival data. Dataset NCT00003088-D5 and NCT00003088-D10 each contain the same clinical data. NCT00003088-D10 also contains a patient reference (patid) that can be tied to patient information submitted to NCTN Navigator submissions.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: 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.
ConditionsBreast Cancer
Intervention TypeDrug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: paclitaxel
Drug(s)Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: paclitaxel
Total Enrolled2005
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionSequential chemotherapy 21 days - Experimental
Concurrent chemotherapy 14 days - Experimental
Sequential chemotherapy 14 days - Experimental
Concurrent chemotherapy 21 days - Experimental
Secondary IDU10CA031946
PubMed (PMID)17704418
16609087
16039867
16381623
15743513
15668278
12668651
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Canada
Age Range18 Years and older (Adult, Older Adult)
Files: NCT00003088-D10
Data DictionaryNCT00003088-D10-Data-Dictionary.pdf
DATANCT00003088-D10-Dataset.csv
OTHERREADME.pdf
Files: NCT00003088-D9
Data DictionaryNCT00003088-D9-Data-Dictionary.pdf
DATANCT00003088-D9-Dataset.csv
OTHERREADME.pdf
Files: NCT00003088-D8
Data DictionaryNCT00003088-D8-Data-Dictionary.pdf
DATANCT00003088-D8-Dataset.csv
OTHERREADME.pdf
Files: NCT00003088-D7
Data DictionaryNCT00003088-D7-Data-Dictionary.pdf
DATANCT00003088-D7-Dataset.csv
OTHERREADME.pdf
Files: NCT00003088-D6
Data DictionaryNCT00003088-D6-Data-Dictionary.pdf
DATANCT00003088-D6-Dataset.csv
OTHERREADME.pdf
Files: NCT00003088-D5
Data DictionaryNCT00003088-D5-Data-Dictionary.pdf
DATANCT00003088-D5-Dataset.csv
OTHERREADME.pdf
Files: NCT00003088-D4
Data DictionaryNCT00003088-D4-Data-Dictionary.pdf
DATANCT00003088-D4-Dataset.csv
OTHERREADME.pdf
Files: NCT00003088-D3
Data DictionaryNCT00003088-D3-Data-Dictionary.pdf
DATANCT00003088-D3-Dataset.csv
OTHERREADME.pdf
Files: NCT00003088-D2
Data DictionaryNCT00003088-D2-Data-Dictionary.pdf
DATANCT00003088-D2-Dataset.csv
OTHERREADME.pdf
Files: NCT00003088-D1
Data DictionaryNCT00003088-D1-Data-Dictionary.pdf
DATANCT00003088-D1-Dataset.csv
OTHERREADME.pdf
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