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Type(s) of Cancer
Breast
Study Phase
Phase 3
Study Completion Date
2014-06-30
NCT00601900Uploaded 01-18-2020
Access via NCI by Request
PDS UID: nci-data-378
Endocrine Therapy With or Without Anti-VEGF Therapy: A Randomized, Phase III Trial of Endocrine Therapy Alone or Endocrine Therapy Plus Bevacizumab (NSC 704865) for Women With Hormone Receptor-Positive Advanced Breast Cancer
Provider Information
Provider Data DescriptionNCT00601900-D2 (AE) data set allows you to reproduce the reported adverse events for this study.
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies tamoxifen citrate or letrozole together with bevacizumab to see how well it works compared with tamoxifen citrate or letrozole alone in treating women with stage IIIB or stage IV breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate or letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Immunotherapy with monoclonal antibodies, such as bevacizumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving hormone therapy is more effective with or without bevacizumab in treating advanced breast cancer.
ConditionsInvasive Breast Carcinoma
Recurrent Breast Carcinoma
Stage III Breast Cancer AJCC v6
Stage IV Breast Cancer AJCC v6 and v7
Intervention TypeBiological: Bevacizumab
Other: Laboratory Biomarker Analysis
Drug: Letrozole
Other: Questionnaire Administration
Drug: Tamoxifen Citrate
Drug(s)Drug: Letrozole
Drug: Tamoxifen Citrate
Total Enrolled394
RandomizationRandomized
Blinding MethodNone
Arms InterventionArm I (endocrine therapy with monoclonal antibody) - Experimental
Arm II (endocrine therapy) - Active Comparator
Secondary IDNCI-2009-00477
PubMed (PMID)34616010
31276981
29789969
27138575
Collaborator(s)N/A
Region(s)United States
Puerto Rico
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT00601900-D2
Data DictionaryNCT00601900-D2-Data-Dictionary_2.pdf
DATANCT00601900-D2-Dataset_2.csv
OTHERREADME.pdf
Files: NCT00601900-D1
Data DictionaryNCT00601900-D1-Data-Dictionary_3.pdf
DATANCT00601900-D1-Dataset_2.csv
OTHERREADME.pdf
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