Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00022672 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 208
- Enrollment target
NCT00022672 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 208 participants.
The verdict
NCT00022672, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 208 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG trastuzumab (Herceptin®)
- DRUG anastrazole (Arimidex®)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 208 participants |
| Start Date | 2001-01 |
| Est. Completion | 2009-10 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00022672
The ClinicalTrials.gov registry entry for NCT00022672 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 208 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which trastuzumab (Herceptin®) is the first listed.
NCT00022672 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00022672 about?
NCT00022672 is a clinical study titled "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". 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 (...
What is the current status of trial NCT00022672?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 208 participants. The study started on 2001-01. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00022672?
The interventions under investigation include: trastuzumab (Herceptin®) (DRUG), anastrazole (Arimidex®) (DRUG).
Who is sponsoring clinical trial NCT00022672?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.