Sequential Versus Simultaneous Use of Vinorelbine and Capecitabine in Patients With Metastatic Breast Cancer (MBC)
Primary Purpose
Breast Cancer, Metastasis, Neoplasm
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Vinorelbine and Capecitabine
Vinorelbine and Capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring metastasis, chemotherapy, breast cancer, Vinorelbine, Capecitabine, sequential chemotherapy, TTF
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
Sites / Locations
- Fudan University Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
combination chemotherapy
sequential chemotherapy
Arm Description
Simultaneous use of Vinorelbine and Capecitabine
Sequential use of Vinorelbine and Capecitabine
Outcomes
Primary Outcome Measures
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)
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.
Secondary Outcome Measures
Safety, QOL(quality of life)
Safety and QOL were assessed every cycle(3 weeks per cycle) and during the follow up time, until 28 days after the last cycle.
TTP(time to progression) and OS (overall survival)
TTP and OS were assessed every cycle(3 weeks per cycle) and during the follow up time, until the event occurs.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00629148
Brief Title
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
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Metastasis, Neoplasm
Keywords
metastasis, chemotherapy, breast cancer, Vinorelbine, Capecitabine, sequential chemotherapy, TTF
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
combination chemotherapy
Arm Type
Active Comparator
Arm Description
Simultaneous use of Vinorelbine and Capecitabine
Arm Title
sequential chemotherapy
Arm Type
Experimental
Arm Description
Sequential use of Vinorelbine and Capecitabine
Intervention Type
Drug
Intervention Name(s)
Vinorelbine and Capecitabine
Intervention Description
Vinorelbine 25mg/m2 D1, D8 q3w Capecitabine 1000mg/m2 D1-D14 q3w
Intervention Type
Drug
Intervention Name(s)
Vinorelbine and Capecitabine
Intervention Description
Vinorelbine 25mg/m2 D1, D8 q3w. When disease progression or untolerated toxicity occurs, Capecitabine 1000mg/m2 D1-D14 q3w
Primary Outcome Measure Information:
Title
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)
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.
Time Frame
Every two cycles (3 weeks per cycle) and during the follow up time, until disease progression event occurs.
Secondary Outcome Measure Information:
Title
Safety, QOL(quality of life)
Description
Safety and QOL were assessed every cycle(3 weeks per cycle) and during the follow up time, until 28 days after the last cycle.
Time Frame
Safety and QOL were assessed every cycle and during the follow up time, until 28 days after the last cycle.
Title
TTP(time to progression) and OS (overall survival)
Description
TTP and OS were assessed every cycle(3 weeks per cycle) and during the follow up time, until the event occurs.
Time Frame
TTP and OS were assessed every cycle and during the follow up time, until the event occurs.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
XiChun Hu, MD, PhD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Cancer Hospital
City
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Learn more about this trial
Sequential Versus Simultaneous Use of Vinorelbine and Capecitabine in Patients With Metastatic Breast Cancer (MBC)
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