A Study Of SU011248 Plus Paclitaxel Versus Bevacizumab Plus Paclitaxel In Patients With Advanced Breast Cancer

Pfizer488 enrolled

Overview

To compare treatment with SU011248 plus paclitaxel versus bevacizumab plus paclitaxel to determine which treatment works better against breast cancer

On May 27, 2009, the independent Data Monitoring Committee (DMC) reviewed the progress of Study A6181094. The DMC determined Study A6181094 had met pre-specified futility criteria and was unlikely to meet its primary endpoint to demonstrate a statistically significant improvement in progression-free survival (PFS) in patients treated with sunitinib plus paclitaxel versus bevacizumab plus paclitaxel. Pfizer notified clinical trial investigators involved in the study and regulatory agencies of these findings. Enrollment in this study has been stopped.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

488

Conditions

Breast Neoplasms

Interventions

SunitinibDRUG

Sunitinib 25 mg daily by oral capsules with titration up to 37.5 mg,

paclitaxelDRUG

Paclitaxel 90 mg/m2 IV, 3 weekly doses every 28 days until progression or unacceptable toxicity.

bevacizumabDRUG

Bevacizumab 10 mg/kg IV every 2 weeks.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of advanced breast cancer. * Measurable disease as per RECIST (Response Evaluation Criterion) in Solid Tumors or bone-only disease. * ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1. Exclusion Criteria: * No prior treatment with cytotoxics in the advanced disease setting. * HER2/neu positive disease unless trastuzumab was previously received or is contraindicated. * Treatment with a taxane in the adjuvant setting unless disease free interval \>12 months after end of treatment.

Locations (250)

Outcomes

Primary Outcomes

Progression-Free Survival (PFS)

Time from date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS = (first event date minus randomization date +1) divided by 30.4

Time frame: From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months or death

Secondary Outcomes

Number of Participants With Objective Response

Objective response = participants with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions. A PR was defined as a \> = 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Time frame: From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months

Duration of Response (DR)

DR=time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to first documentation of objective disease progression or death due to any cause, whichever was first. DR was calculated as \[the date response ended (ie, date of progressive disease or death) minus first CR or PR date that was subsequently confirmed +1)\] divided by 30.4.

Time frame: From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months or death due to any cause

Overall Survival (OS)

OS was defined as the time from date of randomization to death due to any cause. OS (in months) was calculated as (date of death minus randomization date +1) divided by 30.4.

Time frame: From date of randomization up to 5 years. Survival follow-up changed to 28-days after treatment discontinuation when study was discontinued.

Percentage of Participants Surviving at 1 and 2 Years

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Bessemer, Alabama, United States

Pfizer Investigational Site