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

• Status: Unknown status
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Capecitabine; Cyclophosphamide

Criteria

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