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| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 132 Study Locations| Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
More Information
| 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 |
|
Anastrozole Antineoplastic Agents, Hormonal Skin Diseases Trastuzumab Disease Progression |
Breast Neoplasms Aromatase Inhibitors Hormones Breast Diseases |
|
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 |