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NCT00267553 · ClinicalTrials.gov registry record · Phase 3

Treatment and Survival Continuation Study of Atamestane Plus Toremifene vs Letrozole in Advanced Breast Cancer

A Phase 3 study, sponsored by Intarcia Therapeutics.

Terminated
Registry status
Phase 3
Development phase
200
Enrollment target

NCT00267553: Clinical Trial Phase 3 study, sponsored by Intarcia Therapeutics.

NCT00267553 is a Phase 3 study that was terminated before completion, run by Intarcia Therapeutics. The registered enrollment target is 200 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00267553, a Phase 3 study, was terminated before completion, sponsored by Intarcia Therapeutics.

TERMINATED
Registry status
Phase 3
Development phase
200 participants
Enrollment target

Study Summary

Protocol 777-CLP-32 is the treatment and survival continuation protocol of Biomed 777-CLP-29, and will continue to compare combined hormonal therapy using the experimental aromatase inhibitor (AI) atamestane combined with the FDA-approved anti-estrogen toremifene (Fareston®), to the single agent FDA-approved aromatase inhibitor letrozole (Femara®) for the treatment of advanced breast cancer. The purpose of this study is to determine whether maximal estrogen suppression achieved via the combination of atamestane, plus toremifene (Fareston®), is more effective than letrozole (Femara®) in delaying the growth of breast cancer.

Interventions

  • DRUG letrozole
  • DRUG toremifene
  • DRUG Atamestane

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2005-11
Est. Completion 2006-06
Phase Phase 3
Intarcia Therapeutics

16 total trials

Why NCT00267553 stopped before completion

NCT00267553 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower).

The record links to 0 conditions, and to 3 interventions - of which letrozole is the first listed.

NCT00267553 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00267553 about?

NCT00267553 is a clinical study titled "Treatment and Survival Continuation Study of Atamestane Plus Toremifene vs Letrozole in Advanced Breast Cancer". Protocol 777-CLP-32 is the treatment and survival continuation protocol of Biomed 777-CLP-29, and will continue to compare combined hormonal therapy using the experimental aromatase inhibitor (AI) atamestane combined with the FDA-approved anti-estrogen toremifene (Fareston®), to the single agent FDA...

What is the current status of trial NCT00267553?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2005-11. Estimated completion is 2006-06.

What interventions are being tested in trial NCT00267553?

The interventions under investigation include: letrozole (DRUG), toremifene (DRUG), Atamestane (DRUG).

Who is sponsoring clinical trial NCT00267553?

This trial is sponsored by Intarcia Therapeutics, which has 16 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00267553's enrollment target sits among peer trials

200 1353rd of 2000 higher than 613 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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Source: ClinicalTrials.gov NCT00267553, the US trial registry maintained by the National Library of Medicine. NCT00267553 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.