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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

Unique Dataset IDNCT00046527
SponsorCelgene CorporationData ProviderCelgeneTotal Study Enrolled Patients460Comparator (Control) Arm Enrolled Patients225RandomizationYes
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypeDrugDataset TypeOther

Clinical Trial Title

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

Trial Summary and Conditions

This is a controlled, randomized, multicenter, open label, phase III study to evaluate the safety/tolerability and anti-tumor effect of intravenously administered ABI-007 compared to that of TAXOL in patients with metastatic breast cancer. Patients who received anthracycline prior to study enrollment must have a four week interval between last dose of anthracycline and starting study drug. Within each country, patients will be randomized separately according to whether they have or have not received prior therapy with anthracyclines. Patients will receive either ABI-007 or TAXOL for up to 6 cycles. In addition, patients who complete 6 cycles of therapy and do not have progressive disease will be able to continue their arm of treatment (ABI-007 or TAXOL) at the investigator's discretion, provided the withdrawal criteria as defined in Section 3.3.4 have not been met. All patients who were randomized and received at least one dose of ABI-007 or TAXOL will be included in the intent to treat population and will be evaluated for efficacy. All patients in the intent to treat population will be assessed every month for the first three months after completion/withdrawal from this study and then every three months thereafter for survival and time to disease progression.

Data Summary

All data collected are from the comparator arm. This de-identified data set represents 225 patients enrolled from an FDA-approved comparator treatment arm: Polyethylated castor oil-based standard paclitaxel. A total of 454 patients were accrued to the study globally.

Study Objectives

To 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.

Outcome Measures

PRIMARY: The primary efficacy measure was overall response rate (ORR). SECONDARY: Secondary efficacy measures were time to treatment progression (TTP) and overall survival (OS). Quality-of-life (QOL) assessment data (ECOG performance status, scores from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30, and body weight) were also collected

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: CA012 mBC Amendment 3.pdf

CRF: CA012 mBC Annotated CRF.pdf

DATA DICTIONARY: CA012 Data Dictionary Placeholder.docx

DATA SUMMARY: Proc Contents Data Dictionary PDS107.pdf