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

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 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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Metastasis, Neoplasm
• Intervention / Treatment: Drug: Vinorelbine and Capecitabine; Drug: Vinorelbine and Capecitabine

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200032
    • Fudan University Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: combination chemotherapy; Simultaneous use of Vinorelbine and Capecitabine	Drug: Vinorelbine and Capecitabine; Vinorelbine 25mg/m2 D1, D8 q3w Capecitabine 1000mg/m2 D1-D14 q3w; Drug: Vinorelbine and Capecitabine; Vinorelbine 25mg/m2 D1, D8 q3w. When disease progression or untolerated toxicity occurs, Capecitabine 1000mg/m2 D1-D14 q3w
Experimental: sequential chemotherapy; Sequential use of Vinorelbine and Capecitabine	Drug: Vinorelbine and Capecitabine; Vinorelbine 25mg/m2 D1, D8 q3w Capecitabine 1000mg/m2 D1-D14 q3w; Drug: Vinorelbine and Capecitabine; Vinorelbine 25mg/m2 D1, D8 q3w. When disease progression or untolerated toxicity occurs, Capecitabine 1000mg/m2 D1-D14 q3w

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Safety and QOL were assessed every 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.	TTP and OS were assessed every cycle and during the follow up time, until the event occurs.

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: February 26, 2008
• First Submitted That Met QC Criteria: February 26, 2008
• First Posted (Estimate): March 5, 2008

Study Record Updates

• Last Update Posted (Estimate): July 7, 2011
• Last Update Submitted That Met QC Criteria: July 6, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Capecitabine; breast cancer; chemotherapy; Vinorelbine; metastasis; TTF; sequential chemotherapy
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Neoplastic Processes; Breast Neoplasms; Neoplasm Metastasis; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Capecitabine; Vinorelbine
• Other Study ID Numbers: 2007SSVC