A Study to Evaluate the Efficacy and Safety of Herceptin® (Trastuzumab) in Combination With Arimidex® (Anastrozole) an Aromatase Inhibitor Compared to Arimidex® Alone in Patients With Metastatic Breast Cancer

Completed · Phase 3

Conditions studied: Breast Cancer

In brief

This 2 arm study assessed the safety and efficacy of adding intravenous trastuzumab (Herceptin®) to daily oral anastrozole (Arimidex®) tablets as first- and second-line treatment in postmenopausal patients with human epidermal growth factor receptor-2 (HER2) overexpressing metastatic breast cancer (ER+ve and/or PR+ve). Patients were randomized to receive either anastrazole 1 mg per os (po) daily, or anastrazole 1 mg po daily + a loading dose of Herceptin® 4 mg/kg intravenous (iv) followed by weekly doses of Herceptin® 2 mg/kg iv. The anticipated time on study treatment was until disease progression, and the target sample size was 100-500 individuals.

Key facts

Study ID

NCT00022672

Run by

Hoffmann-La Roche

People needed

208

Starts

2001-01-01

Expected to finish

2009-10-01

Last updated by the study team

2013-06-13

Who can join

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

You may qualify if…

• postmenopausal women;
• metastatic breast cancer suitable for endocrine therapy;
• positive hormone receptor status;
• Human epidermal growth factor receptor 2 (HER2) overexpression.

You may not qualify if…

• patients on hormone replacement therapy;
• previous chemotherapy for metastatic disease;
• uncontrolled cardiac disease and history of cardiac failure.

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Los Angeles, California, United States
• Study site — Vallejo, California, United States
• Study site — Gainsville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Plantation, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Chicago, Illinois, United States
• Study site — Kansas City, Kansas, United States
• Study site — Scarborough, Maine, United States
• Study site — Detroit, Michigan, United States
• Study site — Omaha, Nebraska, United States
• Study site — Hackensack, New Jersey, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Santa Fe, New Mexico, United States
• Study site — Rochester, New York, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Cleveland, Ohio, United States
• Study site — Hershey, Pennsylvania, United States
• Study site — Box Hill, Australia
• Study site — Darlinghurst, Australia
• Study site — Waratah, Australia
• Study site — Porto Alegre, Brazil
• Study site — Plovdiv, Bulgaria
• Study site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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