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
Public ClinicalTrials.gov record NCT00022672. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00022672
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 208 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 2001 (Type not available)
- Primary completion
- Oct 2009 (Actual)
- Completion
- Oct 2009 (Actual)
- Last update posted
- Jun 13, 2013
2001 – 2009
United States locations
- U.S. sites
- 20
- U.S. states
- 14
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Phoenix | Arizona | 85006 | — |
| Not listed | Little Rock | Arkansas | 72205-7199 | — |
| Not listed | Los Angeles | California | 90048 | — |
| Not listed | Vallejo | California | 94589 | — |
| Not listed | Gainsville | Florida | 32605 | — |
| Not listed | Miami | Florida | 33176 | — |
| Not listed | Plantation | Florida | 33324 | — |
| Not listed | Chicago | Illinois | 60612 | — |
| Not listed | Chicago | Illinois | 60637 | — |
| Not listed | Kansas City | Kansas | 66160 | — |
| Not listed | Scarborough | Maine | 04074 | — |
| Not listed | Detroit | Michigan | 48202-2689 | — |
| Not listed | Omaha | Nebraska | 68114 | — |
| Not listed | Hackensack | New Jersey | 07601 | — |
| Not listed | Albuquerque | New Mexico | 87131-5636 | — |
| Not listed | Santa Fe | New Mexico | 87505 | — |
| Not listed | Rochester | New York | 14642 | — |
| Not listed | Cincinnati | Ohio | 45267-0562 | — |
| Not listed | Cleveland | Ohio | 44106 | — |
| Not listed | Hershey | Pennsylvania | 17033-0850 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 112 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00022672, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 13, 2013 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00022672 live on ClinicalTrials.gov.