A PHASE 3 STUDY OF SU011248 IN COMBINATION WITH PACLITAXEL VERSUS BEVACIZUMAB WITH PACLITAXEL IN THE FIRST-LINE ADVANCED DISEASE SETTING IN PATIENTS HAVING BREAST CANCER - ND

• Conditions: ocally Recurrent or Metastatic Breast Cancer; MedDRA version: 9.1Level: LLTClassification code 10055113Term: Breast cancer metastatic

• Registration Number: EUCTR2007-002969-12-IT
• Lead Sponsor: PFIZER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-27
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 740

Inclusion Criteria

1. Histologically or cytologically proven diagnosis of breast cancer with evidence of 1) unresectable, locally recurrent, or 2) metastatic disease. Locally recurrent disease must not be amenable to resection OR radiation therapy with curative intent. 2. Measurable disease as per RECIST. Measurable lesions that have been previously radiated will not be considered target lesions unless increase in size has been observed following completion of radiation therapy. 3. Male or female, 18 years of age or older. 4. ECOG performance status 0 or 1. 5. Resolution of all acute toxic effects of prior therapy or surgical procedures to grade /=3.0 g/dL · Absolute neutrophil count (ANC) >/=1500/mL · Platelets >/=100,000/mL · Hemoglobin >/=9.0 g/dL · Serum creatinine Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. HER2/neu positive disease unless trastuzumab was previously received and the patient experience progression or trastuzumab was contraindicated. 2. Receipt of a taxane in the adjuvant setting unless disease free interval >/=12 months after end of treatment. 3. Prior treatment with bevacizumab or SU011248. 4. Prior treatment with cytotoxic anti-cancer therapies in the advanced disease setting. 5. History of dose-limiting hypersensitivity reactions to paclitaxel, Cremophor EL, Chinese hamster ovary cell product or other recombinant human antibodies. 6. Radiation therapy within 2 weeks of first study treatment. 7. Major surgery within 4 weeks of first study treatment. At least 7 days should elapse from the time of minor surgical procedure including placement of an access device. 8. Wounds that have not completely healed, active ulcer(s), or bone fracture(s). 9. Prior high-dose chemotherapy requiring hematopoietic stem cell rescue. 10. Prior radiation therapy to >25% of the bone marrow. 11. Current treatment on another clinical trial. 12. Presence of brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease. 13. Diagnosis of any second malignancy within the last 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix. 14. Any of the following within the 12 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, pulmonary embolus, deep vein thrombosis or other significant thromboembolic events. 15. Ongoing cardiac dysrhythmias of NCI CTCAE grade >/=2, atrial fibrillation of any grade, or QTc interval >450 msec for males or >470 msec for females. 16. Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy). 17. Current treatment with therapeutic doses of coumarin-derived anticoagulant (low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed). 18. History of gross hemorrhage within the past 6 months (eg, hemoptysis or hematuria requiring medical intervention). 19. Known human immunodeficiency virus infection. 20. Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to first day of study medication. 21. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified