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NCT00127933 · ClinicalTrials.gov registry record · Phase 4

XeNA Study - A Study of Xeloda (Capecitabine) in Patients With Invasive Breast Cancer

A Phase 4 study of Breast Cancer, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 4
Development phase
157
Enrollment target
20
Study locations

NCT00127933 is a Phase 4 study of Breast Cancer that has completed, run by Hoffmann-La Roche. The registered enrollment target is 157 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT00127933, a Phase 4 study of Breast Cancer, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 4
Development phase
157 participants
Enrollment target
20
Study locations

Study Summary

This single arm study stratified patients into two treatment cohorts based on HER2-neu overexpression/amplification. Each cohort will be independently powered for the primary endpoint. The study will evaluate the efficacy, safety and impact on quality of life of treatment with oral Xeloda plus intravenous (iv) Taxotere (docetaxel). Patients with HER2-neu negative breast cancer will receive chemotherapy alone with oral Xeloda plus intravenous (iv) Taxotere (docetaxel). Patients with HER2-neu positive breast cancer, will receive the same chemotherapy in combination with intravenous (iv) Herceptin (trastuzumab). Patients will receive 3-weekly cycles of treatment with Xeloda (825mg/m2 oral administration \[po\] twice daily (bid) on days 1-14) + Taxotere (75mg/m2 iv on day 1). HER2-neu positive patients will also receive Herceptin (loading dose of 4mg/kg iv followed by 2mg/kg iv weekly). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Conditions Studied

Breast Cancer

Interventions

  • DRUG Taxotere
  • DRUG capecitabine [Xeloda]
  • DRUG Herceptin (HER2-neu positive patients only)

Study Locations (20)

California

  • - Los Angeles
  • - Montebello
  • - Palm Springs
  • - San Diego

Florida

  • - Melbourne
  • - Miami
  • - Tamarac

Missouri

  • - Jefferson City
  • - Rolla
  • - St Louis

Indiana

  • - Indianapolis
  • - Indianapolis

Connecticut

  • - Farmington

Georgia

  • - Savannah

Iowa

  • - Iowa City

Louisiana

  • - Alexandria

Trial Details

FieldValue
Enrollment Target 157 participants
Start Date 2005-08
Est. Completion 2009-07
Phase Phase 4

Sponsor

Hoffmann-La Roche

909 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00127933

The ClinicalTrials.gov registry entry for NCT00127933 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 157 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (94% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Taxotere is the first listed.

NCT00127933 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Florida, Missouri.

Frequently Asked Questions

What is clinical trial NCT00127933 about?

NCT00127933 is a clinical study titled "XeNA Study - A Study of Xeloda (Capecitabine) in Patients With Invasive Breast Cancer". This single arm study stratified patients into two treatment cohorts based on HER2-neu overexpression/amplification. Each cohort will be independently powered for the primary endpoint. The study will evaluate the efficacy, safety and impact on quality of life of treatment with oral Xeloda plus intra...

What is the current status of trial NCT00127933?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 157 participants. The study started on 2005-08. Estimated completion is 2009-07.

What conditions does trial NCT00127933 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT00127933?

The interventions under investigation include: Taxotere (DRUG), capecitabine [Xeloda] (DRUG), Herceptin (HER2-neu positive patients only) (DRUG).

Who is sponsoring clinical trial NCT00127933?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00127933 being conducted?

This trial has 20 study locations across California, Connecticut, Florida, Georgia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.