Efficacy Study of Gemcitabine-Paclitaxel to Treat Metastatic Breast Cancer

Lilly

Status and phase: Completed; Phase 2

Conditions: Metastatic Breast Cancer

Treatments: Drug: gemcitabine; Drug: paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00316199

9803

B9E-MC-JHST

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

A

Experimental group

Treatment:

Drug: paclitaxel

Drug: gemcitabine