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

Conditions

• Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Enzastaurin — DRUG
  1125 milligrams (mg) loading dose on Day 1 of Cycle 1 only then 500 mg oral once daily, until disease progression
• Bevacizumab — DRUG
  10 milligrams per kilogram (mg/kg) intravenously, Days 1 and 15 every 28 days, until disease progression
• Paclitaxel — DRUG
  90 milligrams per square meter (mg/m\^2), intravenously, Days 1 ,8, and 15 every 28 days until disease progression
• Placebo — DRUG
  Oral, daily, until disease progression

Study Details

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.

Key Dates

First listed

Sep 28, 2007

Start date

Nov 30, 2007

Status verified

Sep 2020

Primary completion

Mar 31, 2008

Completion

Mar 31, 2008

Study Design

Enrollment

2 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Enzastaurin + Bevacizumab + Paclitaxel
  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).
• Placebo Comparator: Bevacizumab + Paclitaxel + Placebo
  Participants randomized to this arm (Arm B) will receive bevacizumab, paclitaxel and placebo until disease progression.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Baseline to measured PD (up to 15 days) ]

Locations (7)

Find similar trials in Newark, DE

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