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

This study has been completed.

First Received: August 10, 2001 Last Updated: May 13, 2009 History of Changes

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00022672

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: trastuzumab [Herceptin] Drug: Anastrazole	Phase III

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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Anastrozole Trastuzumab

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	208
Study Completion Date:	July 2008

Arms	Assigned Interventions
1: Experimental	Drug: trastuzumab [Herceptin] 4mg/kg iv loading dose, followed by 2mg/kg iv weekly Drug: Anastrazole 1mg po daily
2: Active Comparator	Drug: Anastrazole 1mg po daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022672

Show 132 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	BO16216
Study First Received:	August 10, 2001
Last Updated:	May 13, 2009
ClinicalTrials.gov Identifier:	NCT00022672 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anastrozole
Antineoplastic Agents, Hormonal
Skin Diseases
Trastuzumab
Disease Progression

Breast Neoplasms
Aromatase Inhibitors
Hormones
Breast Diseases

Additional relevant MeSH terms:

Anastrozole
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Breast Neoplasms
Enzyme Inhibitors

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Trastuzumab
Aromatase Inhibitors
Breast Diseases

ClinicalTrials.gov processed this record on July 02, 2009