Know Cancer

or
forgot password

Phase II Study of an All-Oral Combination of Capecitabine (X) and Cyclophosphamide (C) in Patients With Anthracycline- and Taxane-Pretreated Metastatic Breast Cancer


Phase 2
18 Years
70 Years
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

Phase II Study of an All-Oral Combination of Capecitabine (X) and Cyclophosphamide (C) in Patients With Anthracycline- and Taxane-Pretreated Metastatic Breast Cancer


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

TTP (first treatment of this regimen to disease progression)

Outcome Time Frame:

every two cycles

Safety Issue:

Yes

Principal Investigator

Zhonghua Wang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University

Authority:

China: Ethics Committee

Study ID:

200507CX

NCT ID:

NCT00589901

Start Date:

August 2006

Completion Date:

December 2008

Related Keywords:

  • Breast Cancer
  • metastatic breast cancer
  • capecitabine
  • synergistic effect
  • chemotherapy
  • Breast Neoplasms

Name

Location