Pemetrexed and Carboplatin in Locally Advanced or Metastatic Breast Cancer

Lilly

Status and phase: Completed; Phase 2

Conditions: Breast Cancer; Neoplasm Metastasis

Treatments: Drug: Carboplatin; Drug: Pemetrexed

Study type: Interventional

Funder types: Industry

Identifiers

NCT00072865

7771

H3E-MW-JMGJ

Details and patient eligibility

About

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)