A Study of Herceptin (Trastuzumab) in Combination With Xeloda (Capecitabine) in Patients With Metastatic or Recurrent HER2-positive Breast Cancer After First-Line or (Neo)Adjuvant Therapy.

Study Overview
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Brief Summary
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This single arm. open-label study will assess the efficacy and safety of Herceptin (trastuzumab) in combination with Xeloda (capecitabine) in patients with metastatic or recurrent HER2-positive breast cancer, refractory to or relapsing after chemotherapy with Herceptin and taxanes. Patients will receive Xeloda 900mg/m2 twice daily orally on days 1-14 of each 3-week cycle and Herceptin 8mg/kg intravenously (iv) on day 1 of the first cycle followed by 6mg/kg iv every 3 weeks. The anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Official Title
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Study of Trastuzumab Combined With Capecitabine on HER2-positive Metastatic Breast Cancer Patients Pretreated With Trastuzumab and Taxanes or HER2- Positive Breast Cancer Patients Relapsed From (Neo)Adjuvant Therapy of Trastuzumab and Taxanes

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: capecitabine [Xeloda]
* Drug: trastuzumab [Herceptin]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients, 18-65 years of age Histologically confirmed HER2-positive breast cancer with measurable lesions (according to RECIST criteria) Metastatic disease after first-line therapy or recurrent disease after (neo)adjuvant therapy with Herceptin and taxanes ECOG performance status 0-2 Exclusion Criteria: CNS metastases which are not well controlled Simultaneous treatment with sorivudine History of another malignancy within the last 5 years except for cured basal cell carcinoma of the skin and cured carcinoma in-situ of the uterine cervix Pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br> | Drug: capecitabine [Xeloda]<br>* 900mg/m2 bid po on days 1-14 of each 3-week cycle<br>Drug: trastuzumab [Herceptin]<br>* 8mg/kg iv on day 1 of the first 3-week cycle, followed by 6mg/kg iv every 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Overall Response | The tumor response was measured according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria (Version 1.1). | Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Disease Progression | Tumor response was evaluated according to RECIST criteria (version 1.1). Progressive Disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time to progression is the time from the date of first dose of drug administration to the date when first disease progression is recorded. | Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death | 
| Overall Survival | Overall survival (OS) is the time from the date of randomization to the date of death irrespective of the cause of death. | Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death | 
| Progression-Free Survival | Tumor response was evaluated according to RECIST criteria (version 1.1). Progressive Disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Participants without progression were censored at the date of last tumor assessment when non progression was documented. | Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death |