Clinical trial NCT01196455: Capecitabine and Mitomycin C in Treatment of Patients With Metastatic Breast Cancer
Official title: Phase II Clinical Study of Capecitabine in Combination With Mitomycin C as First-Line Treatment in Patients With Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Metastasis
Keywords: Metastatic breast cancer patients
Lead sponsor: Croatian Cooperative Group for Clinical Research in Oncology
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2010-09-08
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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 \[creatinine clearance \< 30 mL/min (calculated according to cockcroft and Gault)\]

Primary outcomes:
measure: Response rate
timeFrame: average 5 years
Secondary outcomes:
measure: time to disease progression
timeFrame: average 5 years
measure: overall survival
timeFrame: average 5 years
measure: Toxicity
timeFrame: average 5 years
Other outcomes:
Locations:
city: Split
country: Croatia
facility: Center of oncology
Study officials:
affiliation: Clinical Hospital Split, Center of oncology, Croatia
name: Eduard Vrdoljak, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: