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NCT00073528 · ClinicalTrials.gov registry record · Phase 3
Study Comparing Lapatinib (GW572016) And Letrozole Versus Letrozole In Subjects With Advanced Or Metastatic Breast Cancer
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,286
- Enrollment target
NCT00073528: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT00073528 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 1,286 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00073528, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,286 participants
- Enrollment target
Study Summary
This study evaluated and compared the efficacy and tolerability of lapatinib and letrozole, with letrozole and placebo in post-menopausal women with hormone receptor positive (ER positive and/or PgR positive) advanced or metastatic breast cancer, who had not received prior therapy for advanced or metastatic disease.
Primary Outcome
PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. The date of documented PD is defined as the date of radiological PD as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0), PD is defined as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference th
Interventions
- DRUG Placebo
- DRUG Letrozole
- DRUG Lapatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,286 participants |
| Start Date | 2003-12-09 |
| Est. Completion | 2018-03-22 |
| Phase | Phase 3 |
What the finished NCT00073528 record still lists
NCT00073528 is an interventional study that assigns participants to a tested intervention. Its 1,286 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00073528 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00073528 about?
NCT00073528 is a clinical study titled "Study Comparing Lapatinib (GW572016) And Letrozole Versus Letrozole In Subjects With Advanced Or Metastatic Breast Cancer". This study evaluated and compared the efficacy and tolerability of lapatinib and letrozole, with letrozole and placebo in post-menopausal women with hormone receptor positive (ER positive and/or PgR positive) advanced or metastatic breast cancer, who had not received prior therapy for advanced or me...
What is the current status of trial NCT00073528?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,286 participants. The study started on 2003-12-09. Estimated completion is 2018-03-22.
What interventions are being tested in trial NCT00073528?
The interventions under investigation include: Placebo (DRUG), Letrozole (DRUG), Lapatinib (DRUG).
Who is sponsoring clinical trial NCT00073528?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00073528's enrollment target sits among peer trials
1,286 197th of 2000 higher than 1,804 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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