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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00589901

Enrollment

Registered

2008-01-10

Start date

2006-08-31

Completion date

2008-12-31

Last updated

2008-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

metastatic breast cancer, capecitabine, synergistic effect, chemotherapy

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.

Interventions

DRUGcapecitabine and cyclophosphamide

capecitabine 1000 mg/m2 oral Bid d1-14 cyclophosphamide 65 mg/m2 oral Qd d1-14

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
TTP (first treatment of this regimen to disease progression)	every two cycles

Secondary

Measure	Time frame
side effects	all cycles
pharmacogenetic analysis	collect blood samples before this therapy

Countries

China

Contacts

Primary ContactZhonghua Wang, MD

zhonghuawang95@hotmail.com8613918322628

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026