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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

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

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

NCT ID

NCT00629148

First Posted

February 26, 2008

Last Updated

July 6, 2011

Sponsor

Fudan University

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

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

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

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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