Clinical trial NCT00127933: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2005-08-09
Enrollment: 157
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants Assessed for Pathological Complete Response (pCR) Plus Near Complete (npCR) in Primary Breast Tumor at Time of Definitive Surgery
timeFrame: at the time of definitive surgery; after four 3-week cycles (3-4 months)
Secondary outcomes:
measure: Percentage of Participants With Complete Pathological Response in the Primary Breast Tumor at the Time of Definitive Surgery
timeFrame: at the time of definitive surgery; after four 3-week cycles (3-4 months)
measure: Percentage of Participants With Overall Clinical Response (Complete Response (CR) Plus Partial Response (PR))
timeFrame: post 2 and 4, 3-week cycles of treatment
measure: Percentage of Participants With Local Recurrence
timeFrame: 30 - 1102 days
measure: Participants With Disease-Free Survival
timeFrame: 30 - 1102 days
measure: Participants With Overall Survival
timeFrame: 22 - 1191 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Montebello
country: United States
state: California
city: Palm Springs
country: United States
state: California
city: San Diego
country: United States
state: California
city: Farmington
country: United States
state: Connecticut
city: Melbourne
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Tamarac
country: United States
state: Florida
city: Savannah
country: United States
state: Georgia
city: Indianapolis
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Iowa City
country: United States
state: Iowa
city: Alexandria
country: United States
state: Louisiana
city: Scarborough
country: United States
state: Maine
city: Baltimore
country: United States
state: Maryland
city: Edina
country: United States
state: Minnesota
city: Jefferson City
country: United States
state: Missouri
city: Rolla
country: United States
state: Missouri
city: St Louis
country: United States
state: Missouri
city: Neptune
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Albuquerque
country: United States
state: New Mexico
city: Albuquerque
country: United States
state: New Mexico
city: Santa Fe
country: United States
state: New Mexico
city: New York
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Canton
country: United States
state: Ohio
city: Pittsburgh
country: United States
state: Pennsylvania
city: Pottsville
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Georgetown
country: United States
state: South Carolina
city: Sumter
country: United States
state: South Carolina
city: Memphis
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Burlington
country: United States
state: Vermont
city: Abingdon
country: United States
state: Virginia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: