XeNA Study - A Study of Xeloda (Capecitabine) in Patients With Invasive Breast Cancer
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
1 other identifier
interventional
157
1 country
38
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 breast-cancer
Started Aug 2005
Typical duration for phase_4 breast-cancer
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 5, 2005
CompletedFirst Posted
Study publicly available on registry
August 9, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedResults Posted
Study results publicly available
August 10, 2011
CompletedAugust 10, 2011
July 1, 2011
3.7 years
August 5, 2005
March 30, 2011
July 13, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Assessed for Pathological Complete Response (pCR) Plus Near Complete (npCR) in Primary Breast Tumor at Time of Definitive Surgery
Pathological complete response was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Near pCR (npCR) was defined as the presence of invasive tumor cells with a size of 5 mm or less in aggregate in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Only pathological assessments occurring prior to the first date of adjuvant treatment were included in the analysis of pCR rate.
at the time of definitive surgery; after four 3-week cycles (3-4 months)
Secondary Outcomes (5)
Percentage of Participants With Complete Pathological Response in the Primary Breast Tumor at the Time of Definitive Surgery
at the time of definitive surgery; after four 3-week cycles (3-4 months)
Percentage of Participants With Overall Clinical Response (Complete Response (CR) Plus Partial Response (PR))
post 2 and 4, 3-week cycles of treatment
Percentage of Participants With Local Recurrence
30 - 1102 days
Participants With Disease-Free Survival
30 - 1102 days
Participants With Overall Survival
22 - 1191 days
Study Arms (2)
HER2-NEU Positive
EXPERIMENTALHER2-NEU Negative
EXPERIMENTALInterventions
4mg/kg iv (loading dose) followed by 2mg/kg iv weekly
Eligibility Criteria
You may qualify if:
- women \>=18 years of age;
- newly diagnosed;
- infiltrating (invasive) HER2-neu-negative or HER2-neu-positive breast cancer.
You may not qualify if:
- evidence of metastatic disease, except ipsilateral (same side) axillary lymph nodes;
- previous systemic or local primary treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
Unknown Facility
Los Angeles, California, 90057, United States
Unknown Facility
Montebello, California, 90640, United States
Unknown Facility
Palm Springs, California, 92262, United States
Unknown Facility
San Diego, California, 92123, United States
Unknown Facility
Farmington, Connecticut, 06030, United States
Unknown Facility
Melbourne, Florida, 32910, United States
Unknown Facility
Miami, Florida, 33136, United States
Unknown Facility
Tamarac, Florida, 33321, United States
Unknown Facility
Savannah, Georgia, 31405, United States
Unknown Facility
Indianapolis, Indiana, 46227, United States
Unknown Facility
Indianapolis, Indiana, 46260, United States
Unknown Facility
Iowa City, Iowa, 52242, United States
Unknown Facility
Alexandria, Louisiana, 71301, United States
Unknown Facility
Scarborough, Maine, 04074, United States
Unknown Facility
Baltimore, Maryland, 21201, United States
Unknown Facility
Edina, Minnesota, 55435, United States
Unknown Facility
Jefferson City, Missouri, 65109, United States
Unknown Facility
Rolla, Missouri, 65401, United States
Unknown Facility
St Louis, Missouri, 63141, United States
Unknown Facility
Neptune City, New Jersey, 07754, United States
Unknown Facility
Albuquerque, New Mexico, 87102, United States
Unknown Facility
Albuquerque, New Mexico, 87108, United States
Unknown Facility
Albuquerque, New Mexico, 87131-5636, United States
Unknown Facility
Santa Fe, New Mexico, 87505, United States
Unknown Facility
New York, New York, 10003, United States
Unknown Facility
Charlotte, North Carolina, 28233-3549, United States
Unknown Facility
Canton, Ohio, 44718, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15213, United States
Unknown Facility
Pottsville, Pennsylvania, 17901, United States
Unknown Facility
Charleston, South Carolina, 29425, United States
Unknown Facility
Georgetown, South Carolina, 29442, United States
Unknown Facility
Sumter, South Carolina, 29150, United States
Unknown Facility
Memphis, Tennessee, 38104, United States
Unknown Facility
Memphis, Tennessee, 38120, United States
Unknown Facility
Dallas, Texas, 75231, United States
Unknown Facility
Dallas, Texas, 75390-9034, United States
Unknown Facility
Burlington, Vermont, 05401, United States
Unknown Facility
Abingdon, Virginia, 24211, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffman-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 5, 2005
First Posted
August 9, 2005
Study Start
August 1, 2005
Primary Completion
April 1, 2009
Study Completion
July 1, 2009
Last Updated
August 10, 2011
Results First Posted
August 10, 2011
Record last verified: 2011-07