A Study to Evaluate the Efficacy and Safety of Herceptin (Trastuzumab) in Combination With an Aromatase Inhibitor in Patients With Metastatic Breast Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

August 10, 2001

Last Updated Date

September 16, 2009

Start Date ^ICMJE

January 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Tumor measurements [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Tumor measurements

Change History

Complete list of historical versions of study NCT00022672 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Hematology, serum chemistry, clinical safety assessments, cardiac monitoring. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Safety: Hematology, serum chemistry, clinical safety assessments, and cardiac monitoring.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Drug: trastuzumab [Herceptin]
Drug: Anastrazole

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

202

Estimated Completion Date

July 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Brazil, Bulgaria, Canada, China, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Lithuania, Mexico, Netherlands, Norway, Poland, Russian Federation, South Africa, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00022672

Responsible Party

Clinical Trials, Study Director, Hoffmann-La Roche

Study ID Numbers ^ICMJE

BO16216

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

Information Provided By

Hoffmann-La Roche

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP