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COMPLETED Phase 2

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

NCT00534417 · View on ClinicalTrials.gov ↗

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.

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

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00534417

The ClinicalTrials.gov registry entry for NCT00534417 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Accelerated Community Oncology Research Network, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00534417 reports 10 study locations spanning 8 distinct geographic areas — top geographies include Georgia, Illinois, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00534417?

The interventions under investigation include: fulvestrant (DRUG), capecitabine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00534417?

This trial is sponsored by Accelerated Community Oncology Research Network, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial