Breast Neoplasms
Conditions
Keywords
breast, cancer, tumor, tumour, intravenous, epothilone, taxane, anthracycline
Brief summary
This study will examine whether the investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause breast cancer.
Interventions
DRUGepothilone b
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
The following patients may be eligible for this study: * Histologically or cytologically documented evidence of disease with at least one measurable lesion; * Life expectancy of greater than three (3) months; * Patients who have had only one prior therapy for metastatic disease; * Patients who have received prior treatment with hormonal agents or who have had prior treatment regimens of radiotherapy in addition to one or no previous chemotherapy regimens are eligible; * Patients who have had no prior therapy for metastatic disease, but who have received a taxane and an anthracycline (single or combination therapy) as adjuvant treatment, are eligible. For patients who have had previous radiation therapy to the target lesion(s), the lesion(s) must since have demonstrated progression.
Exclusion criteria
The following patients are not eligible for this study: * Bone-only disease; * Symptomatic pleural effusions; * Symptomatic CNS metastases or leptomeningeal involvement; * Any peripheral neuropathy or unresolved diarrhea greater than Grade 1; * Severe cardiac insufficiency; * Patients taking Coumadin or other warfarin-containing agents with the exception of low dose Coumadin (1 mg or less) for the maintenance of in-dwelling lines or ports; * History of another malignancy within 5 years prior to study entry except curatively treated non-melanoma ckin cancer or cervical cancer in situ; * Active or suspected acute or chronic uncontrolled infection including abcesses or fistulae; * HIV+ patients; * Pregnant or lactating females; * Patients who have had radiation, chemotherapy, or hormonal therapy within the last four (4) weeks excluding palliative radiotherapy to isolated peripheral bone metastases not being used as markers for efficacy; * Patients taking Herceptin less than three (3) weeks prior to study start.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST) | Every 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Time to progression | until disease progression, death or date of last follow-up |
| Overall survival | date of death or last date patient was known to be alive |
| Duration of overall response | every 8 weeks as clinically needed |
| Safety of study drug | weekly for the first 8 weeks, then every other week |
| pharmacokinectics of study drug | every 8 weeks |
Countries
United States
Outcome results
None listed