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Type(s) of Cancer
Breast
Study Phase
Phase 3
Study Completion Date
2013-12-31
NCT00785291Uploaded 09-30-2022
Access via NCI by Request
PDS UID: nci-data-496
A Randomized Phase III Trial of Weekly Paclitaxel Compared to Weekly Nanoparticle Albumin Bound Nab-paclitaxel or Ixabepilone With or Without Bevacizumab as First-Line Therapy for Locally Recurrent or Metastatic Breast Cancer
Provider Information
Provider Data DescriptionThe NCT00785291_D1_(c40502_ae) dataset is one of 3 datasets associated with PubMed ID 26056183. This dataset contains one record per adverse event (AE) per patient for those who began treatment.
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies the side effects and how well different chemotherapy regimens with or without bevacizumab work in treating patients with stage IIIC or stage IV breast cancer. Drugs used in chemotherapy, such as paclitaxel, paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel), and ixabepilone, 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. Bevacizumab may block tumor growth by targeting certain cells and slowing the growth of blood vessels to the tumor. It is not yet known which treatment regimen is more effective in treating patients with breast cancer.
ConditionsEstrogen Receptor Negative
Estrogen Receptor Positive
HER2/Neu Negative
HER2/Neu Positive
Progesterone Receptor Negative
Progesterone Receptor Positive
Recurrent Breast Carcinoma
Stage IIIC Breast Cancer AJCC v6
Stage IV Breast Cancer AJCC v6 and v7
Intervention TypeBiological: Bevacizumab
Drug: Ixabepilone
Other: Laboratory Biomarker Analysis
Drug: Nab-paclitaxel
Drug: Paclitaxel
Other: Questionnaire Administration
Drug(s)Drug: Paclitaxel
Drug: Nab-paclitaxel
Drug: Ixabepilone
Total Enrolled799
RandomizationRandomized
Blinding MethodNone
Arms InterventionArm A (Paclitaxel) - Active Comparator
Arm B (Nab-paclitaxel) - Experimental
Arm C (Ixabepilone) - Experimental
Secondary IDNCI-2009-00476
PubMed (PMID)34616010
28620884
26056183
Collaborator(s)N/A
Region(s)United States
Puerto Rico
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT00785291-D1
Data DictionaryNCT00785291-D1-Data-Dictionary_1.pdf
DATANCT00785291-D1-Dataset_1.csv
OTHERREADME.pdf
Files: NCT00785291-D2
Data DictionaryNCT00785291-D2-Data-Dictionary_1.pdf
DATANCT00785291-D2-Dataset_1.csv
OTHERREADME.pdf
Files: NCT00785291-D3
Data DictionaryNCT00785291-D3-Data-Dictionary_1.pdf
DATANCT00785291-D3-Dataset_2.csv
OTHERREADME.pdf
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