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

Overview

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.

Full Title of Study: “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

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: August 2009

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.

Interventions

• 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

Arms, Groups and Cohorts

• Active Comparator: combination chemotherapy
  • Simultaneous use of Vinorelbine and Capecitabine
• Experimental: sequential chemotherapy
  • Sequential use of Vinorelbine and Capecitabine

Clinical Trial Outcome Measures

Primary 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)
  • Time Frame: Every two cycles (3 weeks per cycle) and during the follow up time, until disease progression event occurs.
  • 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 Measures

• Safety, QOL(quality of life)
  • Time Frame: Safety and QOL were assessed every cycle and during the follow up time, until 28 days after the last cycle.
  • 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)
  • Time Frame: TTP and OS were assessed every cycle and during the follow up time, until the event occurs.
  • TTP and OS were assessed every cycle(3 weeks per cycle) and during the follow up time, until the event occurs.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Fudan University
• Provider of Information About this Clinical Study
  • Xichun Hu/Dr., Fudan University Cancer Hospital
• Overall Official(s)
  • XiChun Hu, MD, PhD, Principal Investigator, Fudan University