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NCT00534417 · ClinicalTrials.gov registry record · Phase 2

Phase II Trial of Capecitabine With Fulvestrant for Postmenopausal Women With Hormone Receptor Positive Metastatic Breast Cancer

A Phase 2 study of Metastatic Breast Cancer, sponsored by Accelerated Community Oncology Research Network.

Completed
Registry status
Phase 2
Development phase
41
Enrollment target
10
Study locations

NCT00534417: Completed Phase 2 study of Metastatic Breast Cancer, sponsored by Accelerated Community Oncology Research Network.

NCT00534417 is a Phase 2 study of Metastatic Breast Cancer that has completed, run by Accelerated Community Oncology Research Network. The registered enrollment target is 41 participants, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (80% lower). The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00534417, a Phase 2 study of Metastatic Breast Cancer, has completed, sponsored by Accelerated Community Oncology Research Network.

COMPLETED
Registry status
Phase 2
Development phase
41 participants
Enrollment target
10
Study locations

Study Summary

The purpose of this study is to determine if the combination of continuous daily capecitabine with fulvestrant on a loading dose schedule will delay disease progression in metastatic breast cancer (MBC) patients.

Primary Outcome

Time to progression is defined as the time from treatment start until objective tumor progression. Progression is defined per Response Evaluation Criteria in Solid Tumors (RECIST)v1.0 guidelines as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions. The median time to progression is the parameter used to describe TTP.

Conditions Studied

Interventions

  • DRUG fulvestrant
  • DRUG capecitabine

Study Locations (10)

Georgia

  • Northeast Georgia Cancer Care - Athens
  • Augusta Oncology Associates - Augusta

Illinois

  • Medical & Surgical Specialists - Galesburg
  • Oncology Specialists - Park Ridge

Florida

  • Advanced Medical Specialties - Miami

Montana

  • Hematology Oncology Centers of the Northern Rockies - Billings

Nevada

  • Las Vegas Cancer Center - Henderson

Pennsylvania

  • The Lancaster Cancer Center, Ltd - Lancaster

Tennessee

  • The West Clinic - Memphis

Virginia

  • Cancer Specialists of Tidewater - Chesapeake

Trial Details

FieldValue
Enrollment Target 41 participants
Start Date 2007-10
Est. Completion 2011-09
Phase Phase 2

What the finished NCT00534417 record still lists

NCT00534417 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (80% lower).

The record links to 1 condition, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which fulvestrant is the first listed.

NCT00534417 lists 10 locations in 8 states (Georgia, Illinois, Florida).

Frequently Asked Questions

What is clinical trial NCT00534417 about?

NCT00534417 is a clinical study titled "Phase II Trial of Capecitabine With Fulvestrant for Postmenopausal Women With Hormone Receptor Positive Metastatic Breast Cancer". The purpose of this study is to determine if the combination of continuous daily capecitabine with fulvestrant on a loading dose schedule will delay disease progression in metastatic breast cancer (MBC) patients.

What is the current status of trial NCT00534417?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2007-10. Estimated completion is 2011-09.

What conditions does trial NCT00534417 study?

This clinical trial studies the following conditions: Metastatic Breast Cancer.

What interventions are being tested in trial NCT00534417?

The interventions under investigation include: fulvestrant (DRUG), capecitabine (DRUG).

Who is sponsoring clinical trial NCT00534417?

This trial is sponsored by Accelerated Community Oncology Research Network, which has 16 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00534417 being conducted?

This trial has 10 study locations across Florida, Georgia, Illinois, Montana, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Metastatic Breast Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00534417's enrollment target sits among peer trials

41 90th of 139 higher than 48 of 139 other Metastatic Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Metastatic Breast Cancer 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 NCT00534417, the US trial registry maintained by the National Library of Medicine. NCT00534417 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.