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

NCT00629148 | Completed Phase 2

• 1 other identifier: 2007SSVC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Metastasis, Neoplasm

Keywords

metastasis; chemotherapy; breast cancer; Vinorelbine; Capecitabine; sequential chemotherapy; TTF

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Safety, QOL(quality of life)

  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 and during the follow up time, until the event occurs.

Study Arms (2)

combination chemotherapy

ACTIVE COMPARATOR

Simultaneous use of Vinorelbine and Capecitabine

Drug: Vinorelbine and Capecitabine

sequential chemotherapy

EXPERIMENTAL

Sequential use of Vinorelbine and Capecitabine

Drug: Vinorelbine and Capecitabine

Interventions

Vinorelbine and Capecitabine DRUG

Vinorelbine 25mg/m2 D1, D8 q3w Capecitabine 1000mg/m2 D1-D14 q3w

combination chemotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Vinorelbine; Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• XiChun Hu, MD, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 26, 2008
• First Posted: March 5, 2008
• Study Start: August 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: December 1, 2010
• Last Updated: July 7, 2011

Record last verified: 2011-06

Locations

CN (1)