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

Phase 2TerminatedNCT00536939

Eli Lilly and Company2 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Breast Cancer

Interventions

EnzastaurinDRUG

1125 milligrams (mg) loading dose on Day 1 of Cycle 1 only then 500 mg oral once daily, until disease progression

BevacizumabDRUG

10 milligrams per kilogram (mg/kg) intravenously, Days 1 and 15 every 28 days, until disease progression

PaclitaxelDRUG

90 milligrams per square meter (mg/m\^2), intravenously, Days 1 ,8, and 15 every 28 days until disease progression

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

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, United States

Outcomes

Primary Outcomes

Progression Free Survival (PFS)

PFS was defined as the time from the date of study enrollment to the first date of objectively determined progressive disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST version 1.0). PD is ≥20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. For participants not known to have died and who did not have PD, PFS was censored at the date of the last progression-free assessment. For participants who received subsequent systemic anticancer therapy (after discontinuation from the study treatment) prior to disease progression or death, PFS was censored at the date of last progression-free assessment prior to the initiation of post-discontinuation systemic anticancer therapy. No participant completed a full cycle of therapy and thus no formal analysis was performed.

Time frame: Baseline to measured PD (up to 15 days)

Secondary Outcomes

Overall Response Rate (ORR)

ORR was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR), assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST version 1.0). CR was defined as the disappearance of all tumor lesions; PR was defined as either ≥30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LDs or complete disappearance of target lesions, with persistence (but not worsening) of 1 or more non-target lesions. In either case of PR, no new lesions should have appeared. The percentage of participants with ORR was calculated as a total number of participants with CR or PR from the start of study treatment until disease progression or recurrence divided by the total number of participants treated, then multiplied by 100. No participant completed a full cycle of therapy and thus no formal analysis was performed.

Time frame: Baseline to measured Progressive disease (up to 15 days)

Number of Participants With Adverse Events (AEs) or Any Serious AEs (SAEs)

A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.

Data from ClinicalTrials.gov

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