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Randomized Multicenter Phase II Study of Sequential Versus Simultaneous Use of Vinorelbine and Capecitabine as First Line Chemotherapy for Patients With Metastatic Breast Cancer

Phase 2
18 Years
70 Years
Not Enrolling
Breast Cancer, Metastasis, Neoplasm

Thank you

Trial Information

Randomized Multicenter Phase II Study of Sequential Versus Simultaneous Use of Vinorelbine and Capecitabine as First Line Chemotherapy for Patients With Metastatic Breast Cancer

The administration of vinorelbine and capecitabine had been implied to be quite useful in
metastatic breast cancer. This study was designed to explore whether sequential and
simultaneous use of vinorelbine and capecitabine have similar efficacy and whether the
sequential way has better tolerability.

Inclusion Criteria:

- Signed informed consent.

- Female, ≥ 18 and ≤ 70 years.

- Histologically confirmed invasive breast cancer.

- Metastatic breast cancer.

- ECOG Performance Status of 0 to 2.

- Life expectancy of more than 3 months.

- Subject must have adequate organ function.

- Normal laboratory values: hemoglobin > 90g/dl, neutrophils > 1.5×10^9/L, platelets >
80×10^9/L, serum creatinine < 1.5×upper limit of normal (ULN), serum bilirubin <
1.5×ULN, ALT and AST < 2.5×ULN.

- Negative serum pregnancy test for women with childbearing potential.

- Good conditions for infusion and willing to have phlebotomy throughout whole study.

- Have ceased anti-tumor treatments including endocrinotherapy and bio-targeted therapy
for more than 28 days.

- Have at least one target lesion according to the Response Evaluation Criteria in
Solid Tumors (RECIST) criteria.

Exclusion Criteria:

- Pregnant or lactating females

- History of other malignancy. However, subjects who have been disease-free for 5
years, or subjects with a history of completely resected non-melanoma skin cancer or
successfully treated in situ carcinoma are eligible

- Concurrent disease or condition that would make the subject inappropriate for study
participation, or any serious medical disorder that would interfere with the
subject's safety

- Active or uncontrolled infection

- Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart

- Concomitant with brain metastases

- Have received chemotherapy after metastasis

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PFS(progression-free survival,defined as the time period between randomization and disease progress or death) and TTF (time to treatment failure, defined as all discontinuations for any cause)

Outcome Description:

PFS was assessed every two cycles (3 weeks per cycle)and during the follow up time, by serum tumor markers, physical examination and image examination, until disease progression event occurs. If a patient has the sign or hint of disease progression, then the lab examination, physical examination or image examination could be taken at any time.

Outcome Time Frame:

Every two cycles (3 weeks per cycle) and during the follow up time, until disease progression event occurs.

Safety Issue:


Principal Investigator

XiChun Hu, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University


China: Ethics Committee

Study ID:




Start Date:

August 2007

Completion Date:

December 2010

Related Keywords:

  • Breast Cancer
  • Metastasis, Neoplasm
  • metastasis
  • chemotherapy
  • breast cancer
  • Vinorelbine
  • Capecitabine
  • sequential chemotherapy
  • TTF
  • Breast Neoplasms
  • Neoplasms
  • Neoplasm Metastasis