A Phase II Study of Biweekly Pemetrexed and Gemcitabine in Patients With Metastatic Breast Cancer
1. Have a performance status of 0 to 2 on the ECOG performance status schedule.
2. Patients may have had up to one prior systemic chemotherapy for metastatic disease is
allowed. Prior adjuvant therapy is allowed if it has been more than one year since
the end of therapy.
3. Patients must have measurable disease as defined by RECIST criteria (Therasse et al.
4. Have adequate organ function including the following
1. Have serious concomitant systemic disorders (eg, active infection) that, in the opinion
of the investigator, would compromise the safety of the patient or compromise the
patient's ability to complete the study.
Type of Study:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the objective tumor response rate for pemetrexed plus gemcitabine administered every 14 days, in patients with MBC who have received up to one prior chemotherapy for metastatic disease(not including prior adjuvant chemotherapy)
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Canada: Health Canada
- Breast Cancer
- Breast Neoplasms