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

Lilly

Status and phase

Terminated

Phase 2

Conditions

Breast Cancer

Treatments

Drug: Paclitaxel

Drug: Placebo

Drug: Enzastaurin

Drug: Bevacizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00536939

11396

H6Q-MC-S038 (Other Identifier)

Details and patient eligibility

About

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

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

2 participants in 2 patient groups, including a placebo group

Enzastaurin + Bevacizumab + Paclitaxel

Experimental group

Description:

Participants randomized to this arm (Arm A) will receive enzastaurin, paclitaxel and bevacizumab until disease progression. Prior to randomization, a safety lead-in will be conducted in 6 participants who will be treated according to Arm A for 2 cycles (1 cycle = 28 days). Only after an acceptable safety analysis of the safety lead-in, will other participants be randomized to Phase 2 (either Arm A or Arm B). In Phase 2, participants from the safety lead-in will continue treatment according to Enzastaurin + Bevacizumab + Paclitaxel (Arm A).

Treatment:

Drug: Bevacizumab

Drug: Enzastaurin

Drug: Paclitaxel

Bevacizumab + Paclitaxel + Placebo

Placebo Comparator group

Description:

Participants randomized to this arm (Arm B) will receive bevacizumab, paclitaxel and placebo until disease progression.

Treatment:

Drug: Placebo

Drug: Bevacizumab

Drug: Paclitaxel