An All-Oral Combination of Capecitabine and Cyclophosphamide in Patients With Metastatic Breast Cancer (MBC)

Phase II Study of an All-Oral Combination of Capecitabine (X) and Cyclophosphamide (C) in Patients With Anthracycline- and Taxane-Pretreated Metastatic Breast Cancer

The primary objective of this study is to evaluate the time to progression. Secondary objectives are safety, OS and pharmacogenetic analysis. Sixty patients will be enrolled into this study.

Xeloda (capecitabine) is converted to 5-fluorouracil by thymidine phosphorylase, and cyclophosphamide is capable of upregulating the expression of thymidine phosphorylase suggesting a synergistic effect.

Inclusion Criteria:

• Histologically confirmed breast cancer
• Anthracycline and taxane pretreated metastatic breast cancer
• Have not been previously treated with capecitabine
• ECOG performance status of ≤ 1
• Are female and ≥ 18 and ≤ 70 years of age
• Have at least one target lesion according to the RECIST criteria

Exclusion Criteria:

• Pregnant or lactating women
• ECOG ≥ 2
• Have been treated with capecitabine
• Evidence of CNS metastasis
• History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix or a contralateral breast cancer
• Abnormal laboratory values: hemoglobin < 8.0 g/dl, neutrophils < 1.5×10^9/L, platelets < 100×10^9/L, serum creatinine > upper limit of normal (ULN), serum bilirubin > ULN, ALT and AST > 5×ULN, AKP > 5×ULN
• Serious uncontrolled intercurrent infection
• Life expectancy of less than 3 months