Combination Chemotherapy of Gemcitabine and Paclitaxel for Metastatic Breast Cancer

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

Summary

To investigate efficacy, safety and PK of gemcitabine and paclitaxel combination in patients with metastatic breast cancer after adjuvant/neo-adjuvant chemotherapy with anthracycline regimen

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

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Paclitaxel

Criteria

Inclusion Criteria:

• Histologically and/or cytologically confirmed breast cancer

• Received adjuvant/neo-adjuvant chemotherapy for breast cancer with anthracycline regimen

• To have at least one measurable region

• Eastern Cooperative Oncology Group (ECOG) Performance Status: 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 breast cancer

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

• To have brain metastases with symptoms

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