A Phase 2 Study of ALIMTA Plus Doxorubicin Administered Every 21 Days in Patients With Advanced Breast Cancer
- Diagnosis of locally advanced or metastatic breast cancer that is not amenable to
- Patients must be chemo-naive or have received only neoadjuvant and/or adjuvant
- At least one measurable lesion.
- No chemotherapy within 4 weeks prior to enrollment.
- Signed informed consent from the patient.
- 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
- Pregnancy and/or breast feeding.
- Inability or unwillingness to take folic acid or vitamin B12 supplementation.
Type of Study:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the antitumor activity of pemetrexed plus doxorubicin, as measured by overall tumor response rate
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Eli Lilly and Company
United States: Food and Drug Administration
- Breast Cancer
- Breast Neoplasms