Status:
UNKNOWN
Capecitabine and Mitomycin C in Treatment of Patients With Metastatic Breast Cancer
Lead Sponsor:
Croatian Cooperative Group for Clinical Research in Oncology
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Breast Cancer
Metastasis
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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 \[creatinine clearance \< 30 mL/min (calculated according to cockcroft and Gault)\]
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT01196455
Start Date
March 1 2006
Last Update
September 8 2010
Active Locations (1)
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1
Center of oncology
Split, Croatia, 21000