Overview

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)