Advanced Breast Cancer MedDRA version: 9.1 Level: LLT Classification code 10006202 Term: Breast cancer stage IV
Conditions
Interventions
Product Name: sunitinib malate
Product Code: SU011248
Pharmaceutical Form: Capsule, hard
CAS Number: 341031-54-7
Current Sponsor code: SU011248
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
PFIZER
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically proven diagnosis of breast cancer with evidence of a unresectable, locally recurrent, or b metastatic disease. Locally recurrent disease must not be amenable to resection or radiation therapy with curative intent. 2. Tumors over-expressing Her-2 3 by immunohistochemistry IHC or FISH-positive . 3. Measurable disease as per RECIST. Presence of at least 1 measurable lesion not previously irradiated. 4. Candidate for treatment with trastuzumab and docetaxel. 5. May have received Prior adjuvant or neo-adjuvant chemotherapy. If adjuvant therapy included trastuzumab, relapse must have occurred / 6 months since last dose of trastuzumab. If adjuvant therapy included a taxane, relapse must have occurred / 12 months since last dose of chemotherapy. Hormonal therapy concurrent or sequential to adjuvant chemotherapy is allowed. Hormonal therapy for advanced disease is allowed but is to be discontinued / 3 weeks prior to study randomization. Not allowed a prior treatment with chemotherapy in the advanced disease setting. 6. May have received prior radiation therapy. A measurable lesion that has been previously irradiated will not be considered a 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 / 1 except alopecia . 10. Adequate organ function as defined by the following criteria Serum aspartate transaminase AST and serum alanine transaminase ALT / 1.5 x upper limit of normal ULN or AST and ALT / 2.5 x ULN if liver function abnormalities are due to underlying malignancy Alkaline phosphatase ALP / 2.5 x ULN Total serum bilirubin 1 x ULN Serum albumin / 3.0 g/dL Absolute neutrophil count ANC / 1500/ L Platelets / 100,000/ L Hemoglobin / 9.0 g/dL Serum creatinine / 1.5 x ULN 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
Exclusion criteria
Exclusion criteria: 1. Histology of inflammatory carcinoma. 2. Prior treatment on a SU011248 clinical trial. 3. Prior treatment with any tyrosine kinase inhibitors, VEGF inhibitors, or other angiogenic inhibitors. 4. History of severe hypersensitivity reactions to docetaxel or to other drugs formulated with polysorbate 80. 5. History of severe hypersensitivity reactions to trastuzumab. 6. AST and/or ALT 1.5 x ULN concomitant with ALP 2.5 x ULN. 7. Major surgery, radiation therapy, or systemic therapy within 3 weeks of study registration. At least 1 week should elapse since minor surgical procedure including placement of an access device or fine needle aspiration. 8. Prior high-dose chemotherapy requiring hematopoietic stem cell rescue. 9. Prior radiation therapy to 25 of the bone marrow whole pelvis is 25 . 10. Current treatment on another clinical trial. 11. Known brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease. 12. Diagnosis of any second malignancy within the last 3 years, except for adequately treated basal cell carcinoma or squamous cell skin cancer or in situ carcinoma of the cervix uteri. 13. 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, or pulmonary embolus. 14. Ongoing cardiac dysrhythmias of grade / 2, atrial fibrillation of any grade, or QTc interval 470 msec. 15. Hypertension that cannot be controlled by medications 150/100 mmHg despite optimal medical therapy . 16. Current treatment with therapeutic doses of Coumadin low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed . 17. Known human immunodeficiency virus infection. 18. Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test serum or urine prior to randomization. 19. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the tolerability of the combination of SU011248 37.5 mg once daily Schedule 2/1 with docetaxel 75 mg/m2 every 3 weeks and trastuzumab therapeutic dose in patients with advanced breast cancer over-expressing Her-2;Secondary Objective: To assess preliminary anti-tumor activity of the combination To determine trough plasma concentrations Ctrough of SU011248 and its active metabolite SU012662, plasma concentrations of paclitaxel and serum concentrations of trastuzumab.;Primary end point(s): Safety profile characterized by type, incidence, severity, timing, seriousness, and relatedness of adverse events; and laboratory abnormalities | — |
Countries
Italy
Outcome results
None listed