A Phase 1/2 Dose-Escalating Study of ALIMTA and Cyclophosphamide Administered Every 21 Days in Patients With Locally Advanced or Metastatic Breast Cancer
Phase 1/Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer
Female
Breast Cancer
Trial Information
A Phase 1/2 Dose-Escalating Study of ALIMTA and Cyclophosphamide Administered Every 21 Days in Patients With Locally Advanced or Metastatic Breast Cancer
Inclusion Criteria:
- You must be female and at least 18 years old.
- You must have been diagnosed with breast cancer.
- Your pre-study lab tests are within study requirements.
- You must be willing to take folic acid and vitamin B12.
Exclusion Criteria:
- You are pregnant or breastfeeding.
- You have another illness that your doctor thinks would make you unable to
participate.
- You are currently taking aspirin or aspirin-like medicine and are unable to stop for
a few days during each cycle of therapy.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Best Tumor Response
Outcome Time Frame:
baseline to measured progressive disease
Safety Issue:
No
Principal Investigator
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9am- 5pm 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:
4029
NCT ID:
NCT00190671
Start Date:
June 2005
Completion Date:
March 2008
Related Keywords:
- Breast Cancer
- Advanced Breast Cancer
- Breast Neoplasms
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