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
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Breast Cancer
Both
Breast Cancer
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Progression Free Survival
Outcome Time Frame:
baseline to measured progressive disease
Safety Issue:
No
Principal Investigator
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)
Investigator Role:
Study Director
Investigator Affiliation:
Eli Lilly and Company
Authority:
United States: Food and Drug Administration
Study ID:
11396
NCT ID:
NCT00536939
Start Date:
November 2007
Completion Date:
March 2008
Related Keywords:
- Breast Cancer
- Breast Neoplasms
Name | Location |
|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chicago, Illinois 60674 |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Indianapolis, Indiana 46227 |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Newark, Delaware 19713 |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Omaha, Nebraska 68114 |
