Study of Gemcitabine and Herceptin Versus Xeloda and Herceptin in HER-2 (+) Metastatic Breast Cancer Patients

Study Overview
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Brief Summary
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The optimal treatment for pretreated patients with metastatic breast cancer has not been established. Gemcitabine and capecitabine are two active agents in this setting. For women with Her-2 positive breast cancer, combinations of either gemcitabine or capecitabine (Xeloda) plus Herceptin has been proved active and well tolerated.

Detailed Description
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This trial compares the efficacy of the combinations gemcitabine plus Herceptin versus capecitabine (Xeloda) plus Herceptin in pretreated patients with metastatic HER-2 positive breast cancer.

Official Title
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A Multicenter Randomized Phase III Study of Gemcitabine Plus Herceptin Combination Versus the Capecitabine Plus Herceptin Combination in Pretreated Patients With HER-2 Positive Metastatic Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Gemcitabine
* Drug: Herceptin
* Drug: Capecitabine (Xeloda)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent Histologically confirmed metastatic breast adenocarcinoma (stage IV) without any prior chemotherapy received HER-2 overexpression 2+ or 3+ using IHC or FISH + Measurable disease At least one prior chemotherapy regimen Not in a prior irradiation field No patients with brain metastatic disease who has not been irradiated or uncontrolled brain metastatic disease after irradiation No more than 25% of myeloproductive bone marrow irradiated. More than 4 weeks since prior radiotherapy and recovered Age 18 - 75 year old Performance status (WHO) 0-2 Life expectancy more than 12 weeks Absolute neutrophil count > 1500/mm^3, platelet count > 100000/mm^3, hemoglobin > 9 gr/mm^3) Adequate liver (bilirubin < 2 mg/dL, SGOT/SGPT < 2 times upper limit of normal, ALP < 3 times upper limit of normal, creatinine < 1.5 upper limit of normal Adequate cardiac function (LVEF > 50%) Exclusion Criteria: Pregnant or nursing Positive pregnancy test Concurrent agents ketoconazole, macrolide antibiotics, zidovudine which may induce P-450 cytochrome Motor or sensory neuropathy > grade 1 according to NCIC toxicity criteria History of allergic reaction attributed to docetaxel Psychiatric illness or social situation that would preclude study compliance Other concurrent uncontrolled illness Other invasive malignancy within the past 5 years except cured basal cell skin carcinoma and cervical carcinoma in situ

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>GHer | Drug: Gemcitabine<br>* Gemcitabine at the dose of 1250 mg/m2 IV on day 1 every 3 weeks for 6 cycles<br>* Other names: Gemzar;Drug: Herceptin<br>* Herceptin 8 mg/Kg (90 min IV) on day 1 for the first cycle and 6 mg/Kg for the 5 remaining cycles over a 30 min IV<br>|
| Experimental: 2<br>CapHer | Drug: Herceptin<br>* Herceptin 8 mg/Kg (90 min IV) on day 1 for the first cycle and 6 mg/Kg for the 5 remaining cycles over a 30 min IV<br>Drug: Capecitabine (Xeloda)<br>* Capecitabine at the dose of 1250 mg/m2 b.i.d p.o on day 1-14 every 3 weeks 6 cycles<br>* Other names: Xeloda;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression (TTP) between the two treatment arms |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 1 year | 
| Toxicity profile |  | During the time of chemotherpy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Metastatic Breast cancer, Her-2 expression, Gemcitabine, Capecitabine, Herceptin