Sequential Versus Simultaneous Use of Vinorelbine and Capecitabine in Patients With Metastatic Breast Cancer (MBC)

NCT ID: NCT00629148

Last Updated: 2011-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2010-12-31

Brief Summary

The primary objective of this study is to evaluate the efficacy and tolerability of sequential use of vinorelbine and capecitabine as first line therapy in patients with MBC.

Detailed Description

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.

Conditions

Breast Cancer; Metastasis, Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

combination chemotherapy

Simultaneous use of Vinorelbine and Capecitabine

Group Type: ACTIVE_COMPARATOR

Vinorelbine and Capecitabine

Intervention Type: DRUG

Vinorelbine 25mg/m2 D1, D8 q3w Capecitabine 1000mg/m2 D1-D14 q3w

sequential chemotherapy

Sequential use of Vinorelbine and Capecitabine

Group Type: EXPERIMENTAL

Vinorelbine and Capecitabine

Intervention Type: DRUG

Vinorelbine 25mg/m2 D1, D8 q3w. When disease progression or untolerated toxicity occurs, Capecitabine 1000mg/m2 D1-D14 q3w

Interventions

Vinorelbine and Capecitabine

Vinorelbine 25mg/m2 D1, D8 q3w Capecitabine 1000mg/m2 D1-D14 q3w

Intervention Type: DRUG

Vinorelbine and Capecitabine

Vinorelbine 25mg/m2 D1, D8 q3w. When disease progression or untolerated toxicity occurs, Capecitabine 1000mg/m2 D1-D14 q3w

Intervention Type: DRUG

Eligibility Criteria

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 failure
• Concomitant with brain metastases
• Have received chemotherapy after metastasis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Fudan University Cancer Hospital

Principal Investigators

XiChun Hu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Cancer Hospital

Shanghai, , China

Countries

China

Other Identifiers

2007SSVC

Identifier Type: -

Identifier Source: org_study_id