Phase 4
Completed N=157
XeNA Study - A Study of Xeloda (Capecitabine) in Patients With Invasive Breast Cancer
Source: ClinicalTrials.gov NCT00127933 ↗Enrolled (actual)
157
Serious AEs
14.1%
Results posted
Aug 2011
Primary outcomePrimary: Percentage of Participants Assessed for Pathological Complete Response (pCR) Plus Near Complete (npCR) in Primary Breast Tumor at Time of Definitive Surgery — 15.8; 50.0 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Assessed for Pathological Complete Response (pCR) Plus Near Complete (npCR) in Primary Breast Tumor at Time of Definitive Surgery |
15.8; 50.0 | — |
| SECONDARY Percentage of Participants With Complete Pathological Response in the Primary Breast Tumor at the Time of Definitive Surgery |
9.9; 35.7 | — |
| SECONDARY Percentage of Participants With Overall Clinical Response (Complete Response (CR) Plus Partial Response (PR)) |
23.8; 23.5 | — |
| SECONDARY Percentage of Participants With Local Recurrence |
3.1; 3.7 | — |
| SECONDARY Participants With Disease-Free Survival |
92; 25 | — |
| SECONDARY Participants With Overall Survival |
118; 32 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00127933). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.