Gemcitabine Monotherapy for Metastatic Breast Cancer After Anthracycline and Taxane Regimen

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

To investigate efficacy, safety and PK of GEM monotherapy after prior chemotherapy with anthracycline and taxane regimen for patients with metastatic breast cancer

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

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Gemcitabine; Taxane

Criteria

Inclusion Criteria:

• Histologically and/or cytologically confirmed breast cancer

• Received prior chemotherapy for metastatic breast cancer with anthracycline and taxane regimen

• To have at least one measurable region

• PS: 0-1

• To have adequate organ function (bone marrow, liver and renal function)

Exclusion Criteria:

• To have Interstitial pneumonia or pulmonary fibrosis

• To have inflammatory carcinoma

• Within 28 days after the latest chemotherapy or radiotherapy, 14 days after the latest hormonal/immunotherapy or 7 days after surgery

• To have brain metastasis with symptom

• To have severe complication (cardiac infarction, infection, drug hyper sensitivity or diabetes)