Pemetrexed and Carboplatin in Locally Advanced or Metastatic Breast Cancer
Phase 2
Completed
- Conditions
- Breast CancerNeoplasm Metastasis
- Registration Number
- NCT00072865
- Lead Sponsor
- Eli Lilly and Company
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 50
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method antitumor activity
- Secondary Outcome Measures
Name Time Method duration of response;time to progressive disease;time to treatment failure
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
🇷🇺Saint Petersburg, Russia, Russian Federation