Trial information
XeNA study - A Study of Xeloda (Capecitabine) in Patients With Invasive Breast Cancer
Status: No longer recruiting
Protocol number: ML18530
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific 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: 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.
Target sample size is 157.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Open Label; Active; Single Group; Safety/Efficacy study
Condition: Breast Cancer
Intervention type: Drug
Intervention name: capecitabine [Xeloda]
Primary outcome: 1. Pathological complete response in primary breast tumor at time of definitive surgery Time frame: Event driven
Key secondary outcomes: 1. Complete pathological response, overall clinical response, local recurrence, disease-free and overall survival. Time frame: Event driven
2. AEs, laboratory parameters Time frame: Throughout study
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.
Gender: Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: September, 2005
Trial registration date: 08/31/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
United States
- Los Angeles, CA
- Montebello, CA
- Palm Springs, CA
- San Diego , CA
- Farmington, CT
- Melbourne, FL
- Miami, FL
- Tamarac, FL
- Savannah, GA
- Indianapolis , IN
- Iowa City, IA
- Scarborough, ME
- Baltimore, MD
- Edina, MN
- Jefferson City, MO
- St Louis, MO
- Albuquerque, NM
- Santa Fe, NM
- Charlotte, NC
- Pittsburgh, PA
- Charleston, SC
- Georgetown, SC
- Sumter, SC
- Memphis , TN
- Dallas, TX
- Burlington, VT
- Abingdon, VA
