Phase III Randomized, Multi Center Study of Sunitinib Malate (SU 011248) or Capecitabine in Subjects with Advanced Breast Cancer who failed both a taxane and an anthracycline chemotherapy regimen or failed with a taxane and for whom further anthracycline therapy is not indicated. - ND
- Conditions
- Treatment of subjects with advanced breast cancer (ABC) who have failed both a taxane and an anthracycline-containing chemotherapy regimen/s (either concurrently or sequentially) or who failed a taxane treatment and for whom further anthracycline therapy is not indicated.MedDRA version: 9.1Level: LLTClassification code 10055113Term: Breast cancer metastatic
- Registration Number
- EUCTR2006-001267-33-IT
- Lead Sponsor
- PFIZER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 700
1. Histologically or cytologically proven diagnosis of breast adenocarcinoma that is not amenable to surgery, radiation, or combined modality 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. Tumor must be HER 2 negative (immunostaining 0, 1+ or FISH negative) 4. Must have received prior treatment with an anthracycline and a taxane either concurrently or sequentially in the neoadjuvant, adjuvant and or/ advanced disease treatment settings. No more than 1 chemotherapy regimen in the advanced setting. 5. Must have received an adequate course of anthracyclines, considered standard for adjuvant and/or metastatic disease therapy. Prior hormonal therapy or immunotherapy in the adjuvant and/or advanced/metastatic disease settings permitted but is to be discontinued at least 3 weeks before enrollment in the study. 6. May have received prior radiation therapy. A measurable lesion that has been previously irradiated will not be considered as target lesion and will be evaluated only when it increases in size. Radiotherapy is to be completed >/=3 weeks prior to study randomization. 7. Female, 18 years of age or older. 8. ECOG performance status 0 or 1. 9. Resolution of all acute toxic effects of prior therapy or surgical procedures to grade /=3.0 g/dL ? Absolute neutrophil count (ANC) >/=1500/?L ? Platelets >/=100,000/?L ? Hemoglobin >/=9.0 g/dL ? Serum creatinine /= 50 ml/min. ? Left ventricular ejection fraction (LVEF) >/=50% as measured by either multigated acquisition (MUGA) scan or echocardiogram (ECHO) 11.Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment. 12. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
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
1. Prior treatment with regimens of chemotherapy in the advanced/metastatic disease setting beyond those containing anthracyclines and taxanes or multiple anthracyclines/ taxanes treatments. Any prior regimen with capecitabine 2. Major surgery, radiation therapy, or systemic therapy within 3 weeks of first study treatment. At least 7 days should elapse from the time of minor surgical procedure including placement of an access device or fine needle aspiration before randomization into this study can occur. 3. Wounds that have not completely healed, active ulcer(s), or bone fracture(s). 4. Prior high-dose chemotherapy requiring hematopoietic stem cell rescue. 5. Prior radiation therapy to >25% of the bone marrow. 6. Current treatment on another clinical trial. 7. Brain metastases, spinal cord compression, or carcinomatous meningitis, or leptomeningeal disease. 8. Bone lesions as the only manifestation of current metastatic breast cancer. 9. 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. 10. 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. 11. Ongoing cardiac dysrhythmias of NCI CTCAE grade >/=2, atrial fibrillation of any grade, or QTc interval >470 msec for females. 12. Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy). 13. Current treatment with therapeutic doses of anticoagulant (low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed). Low molecular weight heparin monitored by INR is allowed. 14. Known human immunodeficiency virus infection. 15. Female patients who are pregnant or nursing, Female patients of child-bearing potential who are unwilling or unable to use adequate contraception to prevent pregnancy during the program. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to first day of study medication. 16. 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. 17. Known hypersensitivity to 5-fluorouracil or capecitbabine 18. Known dihydropyrimidine dehydrogenase deficiency.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method