Clinical trial NCT00629148: Sequential Versus Simultaneous Use of Vinorelbine and Capecitabine in Patients With Metastatic Breast Cancer (MBC)
Official title: Randomized Multicenter Phase II Study of Sequential Versus Simultaneous Use of Vinorelbine and Capecitabine as First Line Chemotherapy for Patients With Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Metastasis, Neoplasm
Keywords: metastasis
chemotherapy
breast cancer
Vinorelbine
Capecitabine
sequential chemotherapy
TTF
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2008-03-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
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)
timeFrame: Every two cycles (3 weeks per cycle) and during the follow up time, until disease progression event occurs.
Secondary outcomes:
measure: Safety, QOL(quality of life)
timeFrame: Safety and QOL were assessed every cycle and during the follow up time, until 28 days after the last cycle.
measure: TTP(time to progression) and OS (overall survival)
timeFrame: TTP and OS were assessed every cycle and during the follow up time, until the event occurs.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
Study officials:
affiliation: Fudan University
name: XiChun Hu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: