Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00097344 · ClinicalTrials.gov registry record · Phase 3
The CAT Study: Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer
A Phase 3 study, sponsored by Intarcia Therapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 842
- Enrollment target
NCT00097344: Clinical Trial Phase 3 study, sponsored by Intarcia Therapeutics.
NCT00097344 is a Phase 3 study that was terminated before completion, run by Intarcia Therapeutics. The registered enrollment target is 842 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00097344, a Phase 3 study, was terminated before completion, sponsored by Intarcia Therapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 842 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether maximal estrogen suppression achieved via the combination of an experimental drug, atamestane, plus an FDA-approved drug, toremifene (Fareston®), is more effective than another approved drug, letrozole (Femara®), in delaying the growth of breast cancer, and whether the side effects of the combined hormonal therapy are different from the side effects of letrozole.
Interventions
- DRUG Letrozole
- DRUG Toremifene
- DRUG Atamestane
- DRUG Aromatase inhibition
- DRUG Estrogen receptor blocker
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 842 participants |
| Start Date | 2004-12 |
| Est. Completion | 2006-08 |
| Phase | Phase 3 |
Why NCT00097344 stopped before completion
NCT00097344 is an interventional study that assigns participants to a tested intervention. The registered 842 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Letrozole is the first listed.
NCT00097344 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00097344 about?
NCT00097344 is a clinical study titled "The CAT Study: Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer". The purpose of this study is to determine whether maximal estrogen suppression achieved via the combination of an experimental drug, atamestane, plus an FDA-approved drug, toremifene (Fareston®), is more effective than another approved drug, letrozole (Femara®), in delaying the growth of breast canc...
What is the current status of trial NCT00097344?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 842 participants. The study started on 2004-12. Estimated completion is 2006-08.
What interventions are being tested in trial NCT00097344?
The interventions under investigation include: Letrozole (DRUG), Toremifene (DRUG), Atamestane (DRUG), Aromatase inhibition (DRUG), Estrogen receptor blocker (DRUG).
Who is sponsoring clinical trial NCT00097344?
This trial is sponsored by Intarcia Therapeutics, which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00097344's enrollment target sits among peer trials
842 392nd of 2000 higher than 1,609 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06027788 · 842 participants · NA
CTSN Embolic Protection Trial
- NCT06439979 · 843 participants · NA
Rural Adult and Youth Sun Protection Study
- NCT06747949 · 844 participants · Phase 3
A Long-term Extension Study of Dazodalibep in Participants With Sjögren's Syndrome (SS)
- NCT04831580 · 840 participants · NA
A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia