An All-Oral Combination of Capecitabine and Cyclophosphamide in Patients With Metastatic Breast Cancer (MBC)
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
metastatic breast cancer, capecitabine, synergistic effect, chemotherapy
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: capecitabine and cyclophosphamide
Type: Drug
Overall Status
Recruiting
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.
Detailed 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Female
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
Location
Fudan University Cancer Hospital
Shanghai, Shanghai, China
Status: Recruiting
Start Date
August 2006
Completion Date
December 2008
Sponsors
Fudan University
Source
Fudan University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page