Official Title: “A Randomized, Open-Label Study of the Effect of Herceptin Plus Arimidex Compared With Arimidex Alone on Progression-Free Survival in Patients With HER2-Positive and Hormone-Receptor Positive Metastatic Breast Cancer”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: trastuzumab [Herceptin]
  • 4mg/kg iv loading dose, followed by 2mg/kg iv weekly
• Drug: Anastrazole
  • 1mg po daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• Tumor measurements
  • Time Frame: Event driven
    Safety Issue?: No

Secondary Measures

• Hematology, serum chemistry, clinical safety assessments, cardiac monitoring.
  • Time Frame: Throughout study
    Safety Issue?: No

Inclusion Criteria:

• postmenopausal women;
• metastatic breast cancer suitable for endocrine therapy;
• positive hormone receptor status;
• HER2 overexpression.

Exclusion Criteria:

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Hoffmann-La Roche

Overall Clinical Trial Officials and Contacts

Clinical Trials Study Director Hoffmann-La Roche, +1 973 235 5000  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00022672

Study ID Number: BO16216

ClinicalTrials.gov Identifier: NCT00022672

Health Authority: United States: Food and Drug Administration