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

Completed · Phase 4

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00127933

Run by

Hoffmann-La Roche

People needed

157

Starts

2005-08-01

Expected to finish

2009-07-01

Last updated by the study team

2011-08-10

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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.

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Montebello, California, United States
• Study site — Palm Springs, California, United States
• Study site — San Diego, California, United States
• Study site — Farmington, Connecticut, United States
• Study site — Melbourne, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Tamarac, Florida, United States
• Study site — Savannah, Georgia, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Iowa City, Iowa, United States
• Study site — Alexandria, Louisiana, United States
• Study site — Scarborough, Maine, United States
• Study site — Baltimore, Maryland, United States
• Study site — Edina, Minnesota, United States
• Study site — Jefferson City, Missouri, United States
• Study site — Rolla, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Neptune City, New Jersey, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Santa Fe, New Mexico, United States
• Study site — New York, New York, United States

Full record on ClinicalTrials.gov

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