Clinical trial · Interventional
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
NCT00589901CI-TRIAL-00001411unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine and cyclophosphamide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- description
- phase II trial of capecitabine and cyclophosphamide in the management of metastatic breast cancer
- interventionNames
- Drug: capecitabine and cyclophosphamide
Primary outcomes (1)
- measure
- TTP (first treatment of this regimen to disease progression)
- timeFrame
- every two cycles
Secondary outcomes (2)
- measure
- side effects
- timeFrame
- all cycles
- measure
- pharmacogenetic analysis
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDFumoleau P, Largillier R, Clippe C, Dieras V, Orfeuvre H, Lesimple T, Culine S, Audhuy B, Serin D, Cure H, Vuillemin E, Morere JF, Montestruc F, Mouri Z, Namer M. Multicentre, phase II study evaluating capecitabine monotherapy in patients with anthracycline- and taxane-pretreated metastatic breast cancer. Eur J Cancer. 2004 Mar;40(4):536-42. doi: 10.1016/j.ejca.2003.11.007. PMID 14962720
- BACKGROUNDEndo M, Shinbori N, Fukase Y, Sawada N, Ishikawa T, Ishitsuka H, Tanaka Y. Induction of thymidine phosphorylase expression and enhancement of efficacy of capecitabine or 5'-deoxy-5-fluorouridine by cyclophosphamide in mammary tumor models. Int J Cancer. 1999 Sep 24;83(1):127-34. doi: 10.1002/(sici)1097-0215(19990924)83:13.0.co;2-6. PMID 10449619
- DERIVEDWang Z, Lu J, Leaw S, Hong X, Wang J, Shao Z, Hu X. An all-oral combination of metronomic cyclophosphamide plus capecitabine in patients with anthracycline- and taxane-pretreated metastatic breast cancer: a phase II study. Cancer Chemother Pharmacol. 2012 Feb;69(2):515-22. doi: 10.1007/s00280-011-1728-3. Epub 2011 Aug 27. PMID 21874317