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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: capecitabine [Xeloda]
* Drug: Taxotere
* Drug: Herceptin (HER2-neu positive patients only)
* Drug: capecitabine [Xeloda]
* Drug: Taxotere


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HER2-NEU Positive<br> | Drug: capecitabine [Xeloda]<br>* 825mg/m2 po bid on days 1-14 of each 3 week cycle<br>Drug: Taxotere<br>* 75mg/m2 iv on day 1 of each 3 week cycle<br>Drug: Herceptin (HER2-neu positive patients only)<br>* 4mg/kg iv (loading dose) followed by 2mg/kg iv weekly<br>|
| Experimental: HER2-NEU Negative<br> | Drug: capecitabine [Xeloda]<br>* 825mg/m2 po bid on days 1-14 of each 3 week cycle<br>Drug: Taxotere<br>* 75mg/m2 iv on day 1 of each 3 week cycle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Assessed for Pathological Complete Response (pCR) Plus Near Complete (npCR) in Primary Breast Tumor at Time of Definitive Surgery | Pathological complete response was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Near pCR (npCR) was defined as the presence of invasive tumor cells with a size of 5 mm or less in aggregate in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Only pathological assessments occurring prior to the first date of adjuvant treatment were included in the analysis of pCR rate. | at the time of definitive surgery; after four 3-week cycles (3-4 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Complete Pathological Response in the Primary Breast Tumor at the Time of Definitive Surgery | Pathological complete response was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. | at the time of definitive surgery; after four 3-week cycles (3-4 months) | 
| Percentage of Participants With Overall Clinical Response (Complete Response (CR) Plus Partial Response (PR)) | The best overall response in an individual patient, according to RECIST, during preoperative treatment was the best response recorded from the start of study treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the baseline assessment) or completion of preoperative treatment. Patients with CR or PR were considered responders. Patients with no tumor assessment after the start of study treatment were considered nonresponders. | post 2 and 4, 3-week cycles of treatment | 
| Percentage of Participants With Local Recurrence | Local recurrence was defined as evidence of recurrent carcinoma in the same breast where it was diagnosed initially before preoperative treatment. | 30 - 1102 days | 
| Participants With Disease-Free Survival | Disease-free survival was defined as the time from date of surgery to date of first evidence of cancer recurrence in the breast (ie, local or distant recurrence or contra lateral disease) or death from any cause, whichever came first. Patients who were alive or withdrawn from the study and had no evidence of disease recurrence and for whom there was CRF evidence that evaluations had been made were censored at the date of the last clinical follow-up assessment when the patient was known to be disease free. | 30 - 1102 days | 
| Participants With Overall Survival | Overall survival was defined as the time from date of start of study treatment to the date of death, regardless of the cause of death. Patients who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Patients without follow-up assessment were censored at the day of the last dose. Patients with no post-baseline information were censored at the start of study treatment. | 22 - 1191 days |