A Phase II Study of Alimta and Carboplatin in the Treatment of Patients With Locally Advanced or Metastatic Breast Cancer
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Neoplasm Metastasis
Female
Breast Cancer, Neoplasm Metastasis
Trial Information
A Phase II Study of Alimta and Carboplatin in the Treatment of Patients With Locally Advanced or Metastatic Breast Cancer
Inclusion Criteria:
- Histologic or cytologic diagnosis of locally advanced or metastatic breast cancer
- No prior chemotherapy for locally advanced or metastatic breast disease.
- Patient may have received prior adjuvant therapy finished greater than 1 year prior
to enrollment.
- Adequate bone marrow, liver and kidney function
- RECIST criteria for disease status
Exclusion Criteria:
- Prior treatment with pemetrexed
- Pregnant or breast feeding
- Brain Metastasis
- unable or unwilling to take folic acid, vitamin B12 supplementation, or
dexamethasone.
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:
antitumor activity
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:
7771
NCT ID:
NCT00072865
Start Date:
June 2003
Completion Date:
September 2005
Related Keywords:
- Breast Cancer
- Neoplasm Metastasis
- Breast Neoplasms
- Neoplasms
- Neoplasm Metastasis
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