Trastuzumab in Combination With Vinorelbine or Taxane-Based Chemotherapy in Patients With Metastatic Breast Cancer

Completed · Phase 3

Conditions studied: Breast Cancer, Stage IV Breast Cancer

In brief

The purpose of this study is to compare two different combinations of chemotherapy with trastuzumab as initial treatment for HER2 positive advanced breast cancer. Half of the patients will receive trastuzumab in combination with a taxane form of chemotherapy (either paclitaxel or docetaxel), while the other group will receive trastuzumab in combination with vinorelbine.

Key facts

Study ID

NCT00146549

Run by

Dana-Farber Cancer Institute

People needed

250

Starts

2001-08-01

Expected to finish

2007-12-01

Last updated by the study team

2009-11-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed invasive breast cancer, with stage IV disease
• Tumors must be HER2 overexpressing
• Measurable disease, defined as a least one lesion that can be accurately measured in at least one dimension
• 18 years of age or older
• Life expectancy of greater than 6 months
• ECOG performance status of 0-2
• ANC count > 1,500/mm3
• Platelets > 100,000/mm3
• Total bilirubin < 1.5 mg/dl
• AST/ALT < 115 U/I
• Creatinine < 2.0 mg/dl
• Glucose < 200 mg/dl
• LVEF > 50%

You may not qualify if…

• Prior chemotherapy or prior trastuzumab therapy for metastatic breast cancer
• Concurrent hormonal therapy, chemotherapy, or radiation treatments
• Pregnant or lactating women
• Known brain metastases or leptomeningeal carcinomatosis
• History of grade 3 or 4 allergic reactions attributed to compounds of similar chemical or biologic composition to the agents in this study
• Pre-existing neuropathy from any cause in excess of grade 1
• Uncontrolled intercurrent illness
• History of other non-breast cancer malignancy except for carcinoma in situ of the cervix or non-melanoma skin cancer
• Patients taking macrolide antibiotics, ketoconazole, or AZT

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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