None listed
Conditions
Interventions
pemetrexed plus doxorubicin Type of group
Pemetrexed 500 mg / m2 in infusion is administered for 10 minutes, followed by 50 mg / m2 of doxorubicin in the form of slow intravenous injection. All patients will receive the following vitamin supplement: 350 to 1000 pg of folic acid by mouth.
Sponsors
ELI LILLY INTERAMERICA INC.,
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosis of locally advanced or metastatic breast cancer that is not amenable to local treatment. Patients must be chemo-naive or have received only neoadjuvant and/or adjuvant chemotherapy. At least one measurable lesion. No chemotherapy within 4 weeks prior to enrollment. Signed informed consent from the patient.
Exclusion criteria
Exclusion criteria: Prior chemotherapy for metastatic breast cancer. Prior treatment with any anthracyclines or anthracenedione-containing regimen. Treatment within the last 30 days with any drug that has not received regulatory approval. Pregnancy and/or breast feeding. Inability or unwillingness to take folic acid or vitamin B12 supplementation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:To assess the antitumor activity of pemetrexed plus doxorubicin, as measured by overall tumor response rate Measure:To assess the antitumor activity of pemetrexed plus doxorubicin, as measured by overall tumor response rate Timepoints:4 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Time to progressive disease Measure:Time to progressive disease Timepoints:4 month | — |
Countries
Brazil, Greece, Hungary, Peru, Poland, Spain, Venezuela
Outcome results
None listed