Montebello,
California
90640
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.