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

Fudan University

Status and phase

Unknown

Phase 2

Conditions

Breast Cancer

Treatments

Drug: capecitabine and cyclophosphamide

Study type

Interventional

Funder types

Other

Identifiers

NCT00589901

200507CX

Details and patient eligibility

About

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.

Full description

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.

Enrollment

60 estimated patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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