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

Phase 2

• Conditions: Breast Cancer
• Interventions: Drug: capecitabine and cyclophosphamide

• Registration Number: NCT00589901
• Lead Sponsor: Fudan University

Brief 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.

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2007-12-26
• Study First Submitted QC: 2008-01-09
• Study First Posted: 2008-01-10
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-17
• Last Update Posted: 2008-04-18
• Primary Completion: 2008-12
• Study Completion: 2008-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	capecitabine and cyclophosphamide	phase II trial of capecitabine and cyclophosphamide in the management of metastatic breast cancer

Primary Outcome Measures

Name	Time	Method
TTP (first treatment of this regimen to disease progression)	every two cycles

Secondary Outcome Measures

Name	Time	Method
side effects	all cycles
pharmacogenetic analysis	collect blood samples before this therapy

Trial Locations

Locations (1)

Fudan University Cancer Hospital; 🇨🇳 Shanghai, Shanghai, China