Breast Neoplasms
Conditions
Keywords
Breast Cancer, Cancer of the Breast
Brief summary
The purpose of this study is to determine the effectiveness of enzastaurin in the treatment of patients with metastatic breast cancer.
Interventions
Sponsors
Eli Lilly and Company
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
* Clinical diagnosis of metastatic breast cancer or recurrent breast cancer where surgery can not be done for curative intent * Have received prior therapy with an anthracycline (class of drugs) and a taxane (class of drugs). * Tumors must not be positive for HER2, but if positive, the treatment plan should not include further treatment with the drug Herceptin. * Disease that can be definitely measured on Cat Scans or other radiological tests. * May have received high dose chemotherapy for autologous stem cell support greater than or equal to 6 months of starting this study.
Exclusion criteria
* More than 2 chemotherapy regimens for metastatic or locally recurrent disease. * Have brain cancer from breast cancer * Pregnant or breastfeeding * Have an inability to swallow tablets * Within 6 months have had a serious heart condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the effects of enzastaurin in the treatment of patients with breast cancer by measuring its ability to reduce the size of the tumor or prevent further increases in tumor size. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the length of time that enzastaurin is able to effect control of the disease. | — |
| To evaluate the side effects of enzastaurin in patients with breast cancer | — |
| To determine whether changes in laboratory tests of patients treated with enzastaurin is associated with the response of their tumors to the drug. | — |
Countries
United States
Outcome results
None listed