Randomized, Placebo-Controlled, Double-Blind, Phase 2 Study Of AG-013736 In Combination With Docetaxel Versus Docetaxel Alone In Patients With Metastatic Breast Cancer Preceded By A Phase 1 Evaluation Of The Combination
Placebo
+ Docetaxel
+ AG-013736 (axitinib)
Breast Diseases+2
+ Breast Neoplasms
+ Neoplasms
Treatment Study
Summary
Study start date: February 1, 2004
Actual date on which the first participant was enrolled.The primary purpose of the study is to determine the time to progression of the combination of study drug (AG-013736) and docetaxel versus docetaxel alone in patients who have not received prior chemotherapy for metastatic breast cancer. The secondary purpose of the study is to determine the dose of study drug that can be given with docetaxel administered on an every 3 week schedule.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.174 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Female patients with histologically/cytologically proven metastatic breast carcinoma (stage IV, or recurrent with local or regional spread or distant metastatic disease) * Adequate bone marrow, liver, and renal function Exclusion Criteria: * Adjuvant chemotherapy given in the past 12 months * Uncontrolled brain metastases
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Group II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 54 locations
Pfizer Investigational Site
Sheffield, United KingdomPfizer Investigational Site
Tucson, United StatesPfizer Investigational Site
Tucson, United States