Pemetrexed and Carboplatin in Locally Advanced or Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a nonrandomized study of pemetrexed plus carboplatin, with the primary objective of determining the efficacy of the combination in tumor reduction, in patients with locally advanced or metastatic breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Carboplatin; Pemetrexed

Criteria

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.