Palm Springs, California 92262

  • Breast Cancer

Purpose:

This single arm study will evaluate the efficacy, safety and impact on quality of life of treatment with oral Xeloda plus intravenous Taxotere (docetaxel) in patients with HER2-neu negative breast cancer, and in combination with iv Herceptin (trastuzumab) in patients with HER2-neu positive breast cancer. Patients will receive 3-weekly cycles of treatment with Xeloda (825mg/m2 po 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.


Criteria:

Inclusion Criteria: - women >=18 years of age; - newly diagnosed; - infiltrating (invasive) HER2-neu-negative or HER2-neu-positive breast cancer. Exclusion Criteria: - evidence of metastatic disease, except ipsilateral (same side) axillary lymph nodes; - previous systemic or local primary treatment.


Study is Available At:


Original ID:

ML18530


NCT ID:

NCT00127933


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Hoffmann-La Roche


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

157


Enrollment Type:

Actual


Overall Contact Information

Official Name:Clinical Trials
Study Director
Hoffmann-La Roche

Study Dates

Completion Date:July 2009
Completion Type:Actual
Verification Date:November 2009
Last Changed Date:November 16, 2009
First Received Date:August 5, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:AEs, laboratory parameters
Time Frame:Throughout study
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Complete pathological response, overall clinical response, local recurrence, disease-free and overall survival.
Time Frame:Event driven
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Pathological complete response in primary breast tumor at time of definitive surgery
Time Frame:Event driven
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:capecitabine [Xeloda]
Description:825mg/m2 po bid on days 1-14 of each 3 week cycle
Arm Name:1
Intervention Type:Drug
Name:Taxotere
Description:75mg/m2 iv on day 1 of each 3 week cycle
Arm Name:1
Intervention Type:Drug
Name:Herceptin
Description:4mg/kg iv (loading dose) followed by 2mg/kg iv weekly (only HER2-neu positive patients)
Arm Name:1

Study Arms

Study Arm Type:Experimental
Arm Name:1

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Hoffmann-La Roche

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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