Alert icon

To align with industry best practices for security and data integrity, Project Data Sphere is requiring users to upgrade their browsers to one that supports encryption protocol TLS 1.2 by December 15, 2017. On that date, Project Data Sphere will disable support of browsers that permit SSL 3.0/TLS 1.0. To prevent any disruption to your access to Project Data Sphere, you must take action.
This browser was not recognized and may not be compatible with TLS 1.2 or higher. Please check with the browser's developer to confirm.
To view information about this, please visit the FAQ. If you have any further questions, please contact us.

Back to the List
Type(s) of Cancer
Breast
Study Phase
Phase 3
Study Completion Date
2001
NCT00046527Uploaded 10-31-2014
Available for Download
PDS UID: Breast_Celgene_2001_107
A Controlled, Randomized, Phase III, Multicenter, Open Label Study of ABI-007(a Cremophor Free, Protein Stabilized, Nanoparticle Paclitaxel) and Taxol in Patients With Metastatic Breast Cancer
Provider Information
Provider Data DescriptionTo compare antitumor activity of ABI-007 with that of TAXOL in metastatic breast cancer patients; and to evaluate the safety/tolerability of ABI-007 compared to that of TAXOL. Additionally, a secondary objectives are to evaluate time to disease progression, survival and to evaluate changes from Baseline in Quality of Life (QOL); and to determine the pharmacokinetics of ABI-007.
SponsorCelgene Corporation
Data ProviderCelgene
Partial set or SubsetOriginal Data
Patients in dataset460
# of Patients Control225
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/m3zx-yn17
CDISC StandardRaw or Case Report Form data
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryPaclitaxel (Taxol, Bristol-Meyers Squibb) has been shown to be very effective against metastatic breast cancer, as well as other cancers. Because the Taxol formulation of paclitaxel is dissolved in Cremophor, an organic solvent containing castor oil, and ethanol, prolonged intravenous administration times are required; and because the solvent has caused hypersensitivity reactions, a premedication schedule is required. ABI-007 is a new anticancer medication containing the same active ingredient as Taxol, paclitaxel, but formulated as a protein-stabilized material that is suspended in salt water and administered intravenously. The time of administration is reduced, the dose of paclitaxel can be higher than is safe for Taxol, and there is no premedication required. This study will determine the efficacy of this new formulation of paclitaxel, as compared to Taxol, for patients with metastatic breast cancer. This is an open label comparative study, so patients will be randomly assigned to receive either the Taxol or ABI-007 forms of paclitaxel, but will know what medication they are receiving. Treatment will be repeated every three weeks unless adverse events or treatment failure require discontinuing study medication.
ConditionsBreast Neoplasms
Metastases, Neoplasm
Intervention TypeDrug: ABI-007
Drug(s)N/A
Total Enrolled460
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionN/A
Secondary IDN/A
PubMed (PMID)N/A
Collaborator(s)N/A
Region(s)United States
Age Range16 Years and older (Child, Adult, Older Adult)
Files:
PROTOCOLCA012 mBC Amendment 3.pdf
CRFCA012 mBC Annotated CRF.pdf
DATA DICTIONARYPDS_Data_Profile_Created_107.xlsx
DATA (COMPARATOR ARM)CA012 Data Files.zip
© 2024 Project Data Sphere
All rights reserved
Privacy PolicyTerms of Use