A Study of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Advanced and/or Metastatic Breast Cancer

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

Summary

This study will assess the efficacy and safety of intravenous (IV) trastuzumab (Herceptin) and IV docetaxel (Taxotere), with or without oral capecitabine (Xeloda), in women with previously untreated HER2-positive advanced and/or metastatic breast cancer.

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

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Capecitabine; Docetaxel; Trastuzumab

Criteria

Inclusion Criteria:

• Histologically confirmed, HER2-positive advanced and/or metastatic breast cancer not amenable to curative therapy

• At least one measurable lesion according to RECIST

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Baseline left ventricular ejection fraction (LVEF) at least 50%

Exclusion Criteria:

• Pregnant, lactating, or women of childbearing potential who are not surgically sterile or not willing to use adequate contraceptive methods

• Previous treatment with Herceptin or other anti-HER therapies, or any previous chemotherapy for advanced or metastatic disease

• Past medical history significant for any cardiac or central nervous system (CNS) disorders

• Poor hematologic, renal, or hepatic function

• Chronic corticosteroid therapy