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

Roche

Status and phase: Completed; Phase 4

Conditions: Breast Cancer

Treatments: Drug: Herceptin (HER2-neu positive patients only); Drug: Taxotere; Drug: capecitabine [Xeloda]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00127933

ML18530

Details and patient eligibility

About

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.

Enrollment: 157 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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157 participants in 2 patient groups

HER2-NEU Positive

Experimental group

Treatment:

Drug: Herceptin (HER2-neu positive patients only)

Drug: Taxotere

Drug: capecitabine [Xeloda]

Drug: capecitabine [Xeloda]

Drug: Taxotere

HER2-NEU Negative

Experimental group

Treatment:

Drug: Taxotere

Drug: capecitabine [Xeloda]

Drug: capecitabine [Xeloda]

Drug: Taxotere