Capecitabine and Mitomycin C in Treatment of Patients With Metastatic Breast Cancer

Study Overview
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Brief Summary
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This is an open-label, non-comparative efficacy and safety study of Capecitabine and Mitomycin C as first-line treatment in patients with previously untreated metastatic breast cancer.

Official Title
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Phase II Clinical Study of Capecitabine in Combination With Mitomycin C as First-Line Treatment in Patients With Metastatic Breast Cancer

Conditions
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Breast Cancer, Metastasis

Intervention / Treatment
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* Drug: Capecitabine and Mitomycin C


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically/cytologically confirmed breast cancer Metastatic breast cancer, having at least one target lesion according to the RECIST criteria. Bone metastases, leptomeningeal disease, ascites, pleural or pericardial effusions, inflammatory breast disease, lymphangitic spread or cystic lesions are not acceptable as target lesions. Target lesions must be ≥ 10 mm longest diameter measured in one dimension using spiral CT, or ≥ 20 mm longest diameter measured in one dimension using conventional techniques. In addition to the definitions pertaining to the target lesion(s) from the RECIST criteria above, the target lesion(s) must not have been previously irradiated (newly arising lesions in previously irradiated areas are acceptable). Age > 18 years Signed informed consent obtained prior to initiation of any study-specific procedures or treatment Exclusion Criteria: Prior cytotoxic chemotherapy or active/passive immunotherapy for metastatic breast disease Prior usage of capecitabine or mitomycin as adjuvant or neoadjuvant treatment Life expectancy < 3 months Not-ambulatory or with an ECOG performance status > 1 Insufficient hematological, renal and hepatic functions: hemoglobin < 8.0 g/dL absolute neutrophils count (ANC) < 1.5 x 109/L platelet count < 100 x 109/L serum creatinine > 1.25 x N* total bilirubin > 2.0 x N* ASAT and/or ALAT > 2.5 x N* (in case of liver metastases > 5 x N*) alkaline phosphatase > 2.5 x N* (in case of liver metastases > 5 x N*, in case of bone metastases > 10 x N*) *N = upper limit of standard range Severe renal impairment [creatinine clearance < 30 mL/min (calculated according to cockcroft and Gault)]

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Capecitabine and Mitomycin C|Capecitabine 1000 mg/m2 twice-daily, administered orally on day 1-14, every three weeks Mitomycin C 8 mg/m2 i.v. bolus, on day 1, every three weeks|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | average 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to disease progression |  | average 5 years | 
| overall survival |  | average 5 years | 
| Toxicity |  | average 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic breast cancer patients