A Phase 2 Study of ALIMTA Plus Doxorubicin Administered Every 21 Days in Patients With Advanced Breast Cancer
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer
Female
Breast Cancer
Trial Information
A Phase 2 Study of ALIMTA Plus Doxorubicin Administered Every 21 Days in Patients With Advanced Breast Cancer
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:
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To assess the antitumor activity of pemetrexed plus doxorubicin, as measured by overall tumor response rate
Principal Investigator
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
Investigator Role:
Study Director
Investigator Affiliation:
Eli Lilly and Company
Authority:
United States: Food and Drug Administration
Study ID:
8426
NCT ID:
NCT00102219
Start Date:
October 2004
Completion Date:
October 2007
Related Keywords:
- Breast Cancer
- Breast Neoplasms
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