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

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00536939
First received: September 26, 2007
Last updated: October 5, 2009
Last verified: October 2009

September 26, 2007
October 5, 2009
November 2007
March 2008   (final data collection date for primary outcome measure)
Progression Free Survival [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
Progression Free Survival
Complete list of historical versions of study NCT00536939 on ClinicalTrials.gov Archive Site
  • Response rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
  • Response rate
  • Safety
Not Provided
Not Provided
 
Trial of Paclitaxel, Bevacizumab, and Enzastaurin Versus Paclitaxel, Bevacizumab and Placebo for Breast Cancer
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Breast Cancer
  • Drug: enzastaurin
    1125 mg loading dose then 500 mg, oral daily, until progressive disease
    Other Name: LY317615
  • Drug: bevacizumab
    10 mg/kg, IV, Day 1 and 15 every 28 days, until disease progression
  • Drug: paclitaxel
    90 mg/m2, IV, Days 1 ,8, and 15 every 28 days until disease progression
  • Drug: placebo
    oral, daily, until disease progression
  • Experimental: A
    Interventions:
    • Drug: enzastaurin
    • Drug: bevacizumab
    • Drug: paclitaxel
  • Placebo Comparator: B
    Interventions:
    • Drug: bevacizumab
    • Drug: paclitaxel
    • Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2
March 2008
March 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00536939
11396, H6Q-MC-S038
Yes
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
Genentech, Inc.
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
Eli Lilly and Company
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP