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Type(s) of Cancer
Breast
Study Phase
Phase 3
Study Completion Date
2014-01-07
NCT00433511Uploaded 02-09-2020
Access via NCI by Request
PDS UID: nci-data-398
A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide Followed by Paclitaxel With Bevacizumab or Placebo in Patients With Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer
Provider Information
Provider Data DescriptionThere are four submissions (each with one dataset) for PMID 30040523 (trial NCT00433511). This dataset, NCT00433511-D2, contains toxicity data. Dataset NCT00433511-D1 contains baseline, treatment, and efficacy data. Dataset NCT00433511-D4 contains updated time-to-event data that have undergone further data cleaning from those in NCT00433511-D1. Dataset NCT00433511-D5 contains data on time to local-regional recurrence and time to distant recurrence that were collected on the trial, but not published.
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, and paclitaxel to see how well they work with or without bevacizumab in treating patients with cancer that has spread to the lymph nodes (lymph node-positive) or cancer that has not spread to the lymph nodes but is at high risk for returning (high-risk, lymph node-negative breast cancer). Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, 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. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery and help prevent the tumor from returning. It is not yet known whether doxorubicin hydrochloride, cyclophosphamide, and paclitaxel are more effective with or without bevacizumab.
ConditionsBreast Adenocarcinoma
Intervention TypeBiological: Bevacizumab
Drug: Cyclophosphamide
Drug: Doxorubicin Hydrochloride
Other: Laboratory Biomarker Analysis
Drug: Paclitaxel
Other: Placebo Administration
Other: Quality-of-Life Assessment
Drug(s)Drug: Cyclophosphamide
Drug: Doxorubicin Hydrochloride
Drug: Paclitaxel
Total Enrolled4994
RandomizationRandomized
Blinding MethodNone
Arms InterventionArm I (chemotherapy, placebo) - Active Comparator
Arm II (chemotherapy, bevacizumab) - Experimental
Arm III (chemotherapy, bevacizumab monotherapy) - Experimental
Secondary IDNCI-2009-00561
PubMed (PMID)35226083
34726788
30054636
30040523
28646344
Collaborator(s)Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
North Central Cancer Treatment Group
Region(s)United States
Peru
South Africa
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT00433511-D2
Data DictionaryNCT00433511-D2-Data-Dictionary_2.pdf
DATANCT00433511-D2-Dataset.csv
OTHERREADME.pdf
Files: NCT00433511-D1
Data DictionaryNCT00433511-D1-Data-Dictionary_2.pdf
DATANCT00433511-D1-Dataset_1.csv
OTHERREADME.pdf
Files: NCT00433511-D4
Data DictionaryNCT00433511-D4-Data-Dictionary_1.pdf
DATANCT00433511-D4-Dataset.csv
OTHERREADME.pdf
Files: NCT00433511-D5
Data DictionaryNCT00433511-D5-Data-Dictionary_1.pdf
DATANCT00433511-D5-Dataset_2.csv
OTHERREADME.pdf
Files: NCT00433511-D3
Data DictionaryNCT00433511-D3-Data-Dictionary_5.pdf
DATANCT00433511-D3-Dataset_4.csv
OTHERREADME.pdf
Files: NCT00433511-D6
Data DictionaryNCT00433511-D6-Data-Dictionary_0.pdf
DATANCT00433511-D6-Dataset.csv
OTHERREADME.pdf
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