XeNA Study - A Study of Xeloda (Capecitabine) in Patients With Invasive Breast Cancer
Public ClinicalTrials.gov record NCT00127933. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-label Study of Xeloda Plus Taxotere on Treatment Response in Patients With HER2-neu-negative, and the Addition of Herceptin for HER2-neu-positive Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00127933
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 157 participants
Conditions and interventions
Conditions
Interventions
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 2005 (Type not available)
- Primary completion
- Apr 2009 (Actual)
- Completion
- Jul 2009 (Actual)
- Last update posted
- Aug 10, 2011
2005 – 2009
United States locations
- U.S. sites
- 38
- U.S. states
- 22
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Los Angeles | California | 90057 | — |
| Not listed | Montebello | California | 90640 | — |
| Not listed | Palm Springs | California | 92262 | — |
| Not listed | San Diego | California | 92123 | — |
| Not listed | Farmington | Connecticut | 06030 | — |
| Not listed | Melbourne | Florida | 32910 | — |
| Not listed | Miami | Florida | 33136 | — |
| Not listed | Tamarac | Florida | 33321 | — |
| Not listed | Savannah | Georgia | 31405 | — |
| Not listed | Indianapolis | Indiana | 46227 | — |
| Not listed | Indianapolis | Indiana | 46260 | — |
| Not listed | Iowa City | Iowa | 52242 | — |
| Not listed | Alexandria | Louisiana | 71301 | — |
| Not listed | Scarborough | Maine | 04074 | — |
| Not listed | Baltimore | Maryland | 21201 | — |
| Not listed | Edina | Minnesota | 55435 | — |
| Not listed | Jefferson City | Missouri | 65109 | — |
| Not listed | Rolla | Missouri | 65401 | — |
| Not listed | St Louis | Missouri | 63141 | — |
| Not listed | Neptune City | New Jersey | 07754 | — |
| Not listed | Albuquerque | New Mexico | 87102 | — |
| Not listed | Albuquerque | New Mexico | 87108 | — |
| Not listed | Albuquerque | New Mexico | 87131-5636 | — |
| Not listed | Santa Fe | New Mexico | 87505 | — |
| Not listed | New York | New York | 10003 | — |
| Not listed | Charlotte | North Carolina | 28233-3549 | — |
| Not listed | Canton | Ohio | 44718 | — |
| Not listed | Pittsburgh | Pennsylvania | 15213 | — |
| Not listed | Pottsville | Pennsylvania | 17901 | — |
| Not listed | Charleston | South Carolina | 29425 | — |
| Not listed | Georgetown | South Carolina | 29442 | — |
| Not listed | Sumter | South Carolina | 29150 | — |
| Not listed | Memphis | Tennessee | 38104 | — |
| Not listed | Memphis | Tennessee | 38120 | — |
| Not listed | Dallas | Texas | 75231 | — |
| Not listed | Dallas | Texas | 75390-9034 | — |
| Not listed | Burlington | Vermont | 05401 | — |
| Not listed | Abingdon | Virginia | 24211 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00127933, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 10, 2011 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00127933 live on ClinicalTrials.gov.