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NCT00417885 · ClinicalTrials.gov registry record · Phase 1

A Clinical Trial Assessing Efficacy and Safety of Sunitinib and Exemestane in Patients With ER [Estrogen Receptor] + and/or PgR [Progesterone Receptor] + Breast Cancer

A Phase 1 study, sponsored by Pfizer.

Terminated
Registry status
Phase 1
Development phase
6
Enrollment target

NCT00417885: Clinical Trial Phase 1 study, sponsored by Pfizer.

NCT00417885 is a Phase 1 study that was terminated before completion, run by Pfizer. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00417885, a Phase 1 study, was terminated before completion, sponsored by Pfizer.

TERMINATED
Registry status
Phase 1
Development phase
6 participants
Enrollment target

Study Summary

To assess progression-free survival at the combination dose determined in the Phase 1 portion of the study, and safety of sunitinib combined with exemestane in patients with metastatic or locally-recurrent, unresectable breast cancer.

Primary Outcome

PFS was defined as the time from enrollment to first documentation of objective tumor progression or to death on study due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS was to be calculated as (first event date - the date of enrollment +1)/7.

Interventions

  • DRUG exemestane
  • DRUG sunitinib malate

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2007-06
Est. Completion 2009-07
Phase Phase 1
Pfizer

1,845 total trials

Why NCT00417885 stopped before completion

NCT00417885 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 2 interventions - of which exemestane is the first listed.

NCT00417885 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00417885 about?

NCT00417885 is a clinical study titled "A Clinical Trial Assessing Efficacy and Safety of Sunitinib and Exemestane in Patients With ER [Estrogen Receptor] + and/or PgR [Progesterone Receptor] + Breast Cancer". To assess progression-free survival at the combination dose determined in the Phase 1 portion of the study, and safety of sunitinib combined with exemestane in patients with metastatic or locally-recurrent, unresectable breast cancer.

What is the current status of trial NCT00417885?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2007-06. Estimated completion is 2009-07.

What interventions are being tested in trial NCT00417885?

The interventions under investigation include: exemestane (DRUG), sunitinib malate (DRUG).

Who is sponsoring clinical trial NCT00417885?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00417885's enrollment target sits among peer trials

6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT00417885, the US trial registry maintained by the National Library of Medicine. NCT00417885 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.