Efficacy Study of Gemcitabine-Paclitaxel to Treat Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine the response rate to a gemcitabine-paclitaxel combination administered on a 3-weekly schedule in Chinese patients with unresectable, locally recurrent breast cancer or metastatic breast cancer.

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

Details

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

Criteria

Inclusion Criteria:

• Female patients of Chinese origin with histologically or cytologically proven diagnosis of breast cancer.

• Unresectable, locally recurrent breast cancer or stage IV disease.

• Have at least one measurable lesion as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.

• Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Scale

• Treatment with an anthracycline-based chemotherapy regimen in the adjuvant/neoadjuvant setting with subsequent disease relapse.

Exclusion Criteria:

• Prior chemotherapy for unresectable, locally advanced breast cancer or metastatic disease.

• Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.

• Known or suspected brain metastasis or second primary malignancy that is clinically detectable at the time of consideration for study enrollment.

• Active infection or other serious condition.

• Pregnant or breastfeeding.