Trial of Paclitaxel, Bevacizumab, and Enzastaurin Versus Paclitaxel, Bevacizumab and Placebo for Breast Cancer - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 26, 2007

Last Updated Date

August 12, 2008

Start Date ^†

November 2007

Current Primary Outcome Measures ^†

Progression Free Survival [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00536939 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Response rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
Safety [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Trial of Paclitaxel, Bevacizumab, and Enzastaurin Versus Paclitaxel, Bevacizumab and Placebo for Breast Cancer

Official Title ^†

A Randomized, Double-Blind, Phase 2 Trial of Paclitaxel Plus Bevacizumab and Enzastaurin Versus Paclitaxel Plus Bevacizumab and Placebo for Locally Recurrent or Metastatic Breast Cancer

Brief Summary

The purpose of this study is to determine efficacy and safety of paclitaxel, bevacizumab and enzastaurin versus paclitaxel, bevacizumab, and placebo in patients who are diagnosed with locally recurrent or metastatic breast cancer.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Breast Cancer

Intervention ^†

Drug: enzastaurin
Drug: bevacizumab
Drug: paclitaxel
Drug: placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

March 2008

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Must have signed an inform consent document
Have histologic or cytologic diagnosis of breast cancer with evidence of unresectable locally recurrent or metastatic disease
Have not received any prior chemotherapy for locally recurrent or metastatic disease
Have not had adjuvant or neoadjuvant taxane therapy within 12 months prior to assignment to study treatment
Age 18 years or older at time of informed consent

Exclusion Criteria:

Have any clinical evidence of central nervous system (CNS) metastases
Have a history of seizure
Have had a major surgical procedure within 4 weeks prior to assignment to study treatment
Have had a minor surgical procedure, placement of an access device, or fine needle aspiration within 7 days prior to assignment to study treatment
Have symptomatic peripheral vascular disease

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00536939

Responsible Party

Chief Medical Officer, Eli Lilly

Secondary IDs ^††

H6Q-MC-S038

Study Sponsor ^†

Eli Lilly and Company

Collaborators ^††

Genentech

Investigators ^†

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

Information Provided By

Eli Lilly and Company

Verification Date

August 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.