Vinorelbine/Gemcitabine Versus Vinorelbine/Cisplatin in Metastatic Breast Cancer

Study Overview
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Brief Summary
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Development of an active second-line treatment option for metastatic breast cancer patients previously pre-treated with anthracyclines and taxanes in neoadjuvant, adjuvant or palliative settings.For each randomisation arm, 100 patients will be included. The trial was performed as a 2-stage phase II study according to the optimal design by Simon with overall response rate as the primary objective. Study Design: Arm A Vinorelbine 25 mg/m2 d1, 8;Gemcitabine 1000 mg/m2 d1, 8 q 3 weeks Arm B Vinorelbine 25 mg/m2 d1, 8;Cisplatin 25 mg/m2 d1, 2,3 q 3 weeks

Official Title
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Randomised, Multicenter Phase II Study in Patients With Metastatic Breast Cancer With Vinorelbine Plus Gemcitabine Versus Vinorelbine Plus Cisplatin

Conditions
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Metastatic Breast Cancer

Intervention / Treatment
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* Drug: Vinorelbine
* Drug: Gemcitabine
* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed metastatic breast cancer All patients were required to give written informed consent To have received a previous treatment with anthracyclines and taxanes Previous radiotherapy is allowed, whenever the radiated area is not the only disease location At least 4 weeks since the last previous antineoplastic treatment Patients must have recovered from all previous toxicities Karnofsky Performance status >= 70% Adequate hematological, renal, cardiac and hepatic function Life expectancy of at least 12 weeks Patients able to comply and to receive an adequate follow-up Exclusion Criteria: Only bone metastases Active infection Previous treatment with one of the study drugs Application of other cytotoxic chemotherapy Insufficient renal function (creatinine clearance < 60ml/min) Clinically unstable brain metastasis Pregnancy or lactation Other primary malignancies (other than carcinoma-in-situ of the cervix or adequately treated basal cell cancer of the skin) Abnormal liver function (bilirubin > 2.0-fold upper normal limit (UNL); Alanine aminotransferase and aspartate aminotransferase >2.5-fold UNL). In patients with hepatic metastasis, a value of Alanine aminotransferase and aspartate aminotransferase of up to 5-fold UNL is permitted Males Second malignancy (except for cervix carcinoma in situ or skin carcinoma - no melanoma- with an adequate treatment). Previous malignancies are allowed if disease-free survival is superior to 5 years, except for renal carcinoma or melanoma

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: A<br>Vinorelbine 25 mg/m2 d1, 8; Gemcitabine 1000 mg/m2 d1, 8 q 3 weeks | Drug: Vinorelbine<br> <br> Drug: Gemcitabine<br> <br> |
| Experimental: B<br>Vinorelbine 25 mg/m2 d1, 8; Cisplatin 25 mg/m2 d1,2,3 q 3 weeks | Drug: Vinorelbine<br> <br> Drug: Cisplatin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months | 
| Clinical Benefit Rate |  | Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months | 
| Duration of response |  | Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months | 
| Incidence of Treatment-Emergent Adverse Events | Safety of treatment will be evaluated by the frequency of adverse events and serious adverse events, clinically significant abnormal laboratory tests, vital signs, and Eastern Cooperative Oncology Group(ECOG)performance status(PS). All patients who received at least one dose of study treatment will be included in the safety analysis. | Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months |