Breast Neoplasms
Conditions
Brief summary
To determine the antitumor efficacy and the safety of SU-014813 at a dose of 100 mg orally once daily in patients with Metastatic Breast Cancer
Interventions
DRUGSU014813
100 mg capsule/day for 6 cycle of 21 days
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically proven diagnosis of metastatic breast adenocarcinoma that is not amenable to surgery, radiation, or combined modality therapy with curative intent. * Must have received prior treatment with an anthracycline and a taxane either concurrently or sequentially in the adjuvant and/or advanced disease treatment settings. Patients may have received as many as 2 other chemotherapy regimens in the advanced disease setting. Patients whose tumors are Her-2-positive must have received prior trastuzumab therapy. Prior hormonal therapy or immunotherapy in the adjuvant and/or advanced/metastatic disease settings is permitted. Prior treatment with surgery, radiotherapy, chemoembolization therapy, or cryotherapy is allowed if these therapies did not affect the areas of measurable disease.
Exclusion criteria
* Prior treatment with \>/= 3 regimens of chemotherapy in the metastatic disease setting beyond those containing anthracyclines and taxanes * Uncontrolled brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease. Patients should have completed surgery or radiation therapy for existing brain metastases, should not have documented increase in size over the previous 3 months and should be asymptomatic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the antitumor efficacy of single agent SU-014813 at a dose of 100 mg orally once daily in patients with MBC | June 2008 |
Secondary
| Measure | Time frame |
|---|---|
| To assess onset and duration of tumor control and 1-year survival rate | AUG 2008 |
| To evaluate the safety of SU-014813To assess patient reported outcomes | AUG 2008 |
| To determine SU-014813 plasma trough concentration (Ctrough) | AUG 2008 |
| To explore the relationship between Ctrough and efficacy, safety, and biomarkers | AUG 2008 |
| To explore the correlations of cancer biomarkers with treatment-related outcomes | AUG 2008 |
Countries
Germany, Italy, Netherlands, United Kingdom, United States
Outcome results
None listed