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NCT00201864 · ClinicalTrials.gov registry record · Phase 2

Exemestane in Combination With Fulvestrant in Postmenopausal Women With Hormone Sensitive Advanced Breast Cancer

A Phase 2 study, sponsored by Ohio State University Comprehensive Cancer Center.

Completed
Registry status
Phase 2
Development phase
40
Enrollment target

NCT00201864: Completed Phase 2 study, sponsored by Ohio State University Comprehensive Cancer Center.

NCT00201864 is a Phase 2 study that has completed, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00201864, a Phase 2 study, has completed, sponsored by Ohio State University Comprehensive Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
40 participants
Enrollment target

Study Summary

The purpose of this trial is to evaluate time to progression in women with hormone responsive advanced breast cancer treated with a combination of exemestane and fulvestrant.

Primary Outcome

TTP is defined as the time from first treatment to objective evidence of progression on the basis of radiological evaluation and/or physical exam (if physical examination identifies a site of measurable disease). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Interventions

  • DRUG Exemestane
  • DRUG Fulvestrant

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2005-09
Est. Completion 2014-02
Phase Phase 2

What the finished NCT00201864 record still lists

NCT00201864 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).

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

NCT00201864 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00201864 about?

NCT00201864 is a clinical study titled "Exemestane in Combination With Fulvestrant in Postmenopausal Women With Hormone Sensitive Advanced Breast Cancer". The purpose of this trial is to evaluate time to progression in women with hormone responsive advanced breast cancer treated with a combination of exemestane and fulvestrant.

What is the current status of trial NCT00201864?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2005-09. Estimated completion is 2014-02.

What interventions are being tested in trial NCT00201864?

The interventions under investigation include: Exemestane (DRUG), Fulvestrant (DRUG).

Who is sponsoring clinical trial NCT00201864?

This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 341 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00201864's enrollment target sits among peer trials

40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00201864, the US trial registry maintained by the National Library of Medicine. NCT00201864 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.