Combination Chemotherapy of Gemcitabine and Paclitaxel for Metastatic Breast Cancer

Lilly

Status and phase

Completed

Phase 2

Conditions

Metastatic Breast Cancer

Treatments

Drug: paclitaxel

Drug: gemcitabine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00334802

B9E-JE-MB22 (Other Identifier)

9066 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Enrollment

62 patients

Sex

Female

Ages

20 to 74 years old

Volunteers

No Healthy Volunteers

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)