METASTATIC BREAST CANCER (MBC)
Conditions
Sponsors
SONUS Pharmaceuticals, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a)Female patient with histologic diagnosis of breast carcinoma. b)Stage IV (M1) disease (see Appendix 2). c)No more than one cytotoxic chemotherapy regimen for treatment of MBC. A chemotherapy regimen is defined as a minimum of 2 consecutive cycles of chemotherapy. Such a regimen should preferably have included an anthracycline. d)Adult (18 years of age or older) patients. e)ANC ³ 1,500 cells/mm3, platelets ³ 100,000/mm3 and hemoglobin ³ 10 g/dL. f)Serum creatinine £ 2.5 mg/dL (or £ 221 µmol/L). g)Total bilirubin £ 1.5 times the upper limit of institutional normal values (ULN). h)AST/SGOT and ALT/SGPT £ 2.5 times the ULN. i)PT and PTT within institutional normal range. j)ECOG performance status 0-1 (see Appendix 3). k)At least one unidimensionally measurable lesion as defined by RECIST, assessable by radiographic evaluation (see Section 9.2). l)A signed IRB / Ethics Committee approved Informed Consent. m)Life expectancy of at least 12 weeks. n)Fully recovered from any previous surgery (at least 4 weeks since major surgery). o)If of child bearing potential, a negative pregnancy test within 1 week of randomization. (Such patients must agree to use a medically effective form of contraception during the treatment). p)Agree not to take vitamin E supplementation while receiving study medication, other than vitamin E that may be included in over the counter multi-vitamin supplement. 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: a)Patients treated with a taxane within the past 1-year. b)Patients whose tumor tissue is known to show over expression (e.g., FISH analysis = 2 or IHC = 2+) of HER2/neu. c)Bone metastasis, effusions/ascites or elevated serum tumor markers as the only evidence of metastatic disease. d)Brain metastases or neurologic examination suggesting a mass effect. e)Active bowel obstruction. f)Patients who were known to have a cancer of other primary origin (excluding Stage I skin cancer) within the last 5 years or cancer of other primary origin that cannot be histologically distinguished from breast cancer. g)Patients who are pregnant or lactating. h)Peripheral neuropathy NCI-CTCAE Grade 2 or higher. i)Wide-field irradiation within 4 months before first dose of study drug. j)Treatment with a cytotoxic chemotherapy or any investigational agent within 4 weeks, or mitomycin or nitrosoureas within 6 weeks before first dose of study drug. k)Concurrent therapy with warfarin at doses greater than 1 mg/day or equivalent doses of other coumarin derivatives. l)Active infection or any other serious medical condition likely to impair the patient’s ability to tolerate cytotoxic chemotherapy. m) History of hypersensitivity to Cremophor EL or anaphylactoid reaction to taxanes. n)Any circumstance likely to impair the patient’s ability to comply with the requirements of the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Compare the median OS and PFS durations in patients treated with these regimens. These endpoints will be the basis for secondary analyses. Compare TTP and clinical benefit duration in patients treated with these regimens. These endpoints will be the basis for additional analyses. Compare the toxicities of the two treatment regimens. ;Primary end point(s): The primary endpoint for this study is the confirmed overall response rate (ORR = OR/n and OR = CR + PR) . Thus, patients observed to have CR or PR should have confirmatory studies performed no sooner than 4 weeks but no later than 5 weeks after CR or PR is observed. ;Main Objective: The goals of the present study are to: Compare objective response rate (ORR) in patients with MBC treated with TOCOSOL Paclitaxel or Taxol weekly as first or second-line therapy. This endpoint will be the basis for the primary efficacy analysis. | — |
Countries
Belgium, Hungary, Italy, Slovakia, Spain, United Kingdom
Outcome results
None listed