Breast Cancer
Conditions
Brief summary
The purposes of this study are to determine the safety of pemetrexed and any side effects that might be associated with it, whether pemetrexed can help patients with breast cancer and how much pemetrexed should be given to patients.
Interventions
DRUGpemetrexed
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be at least 18 years of old. * Have been diagnosed with breast cancer * At least one year disease-free interval after initial treatment. * Have pre-study laboratory tests that are within the requirements of this study. * Be able to visit the doctor's office weekly during the treatment period.
Exclusion criteria
* To be pregnant or breastfeeding. * To be currently taking aspirin or aspirin- like medicine and unable to stop for a few days during each cycle of therapy. * To have received prior chemotherapy for the treatment of metastatic cancer. Patients may have received prior hormonal treatment. * To have another illness that your doctor thinks would make you unable to participate. * To be unable or not willing to take folic acid and vitamin B12.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess tumor response. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the toxicity profile of two doses of pemetrexed in breast cancer patients. | — |
| To assess the following time-to-event efficacy variables: time to response, duration of response, duration of stable disease, time to documented progressive disease, time to treatment failure, progression-free survival, and overall survival. | — |
| To identify the relationships, if any, that may exist between various molecular markers and pemetrexed efficacy and toxicity. | — |
Countries
Argentina, Belgium, Germany, Romania, Spain, United Kingdom
Outcome results
None listed