Efficacy of Capecitabine Metronomic Chemotherapy to Triple-negative Breast Cancer (SYSUCC-001)
The primary objective of this study is to compare disease-free survival (DFS) of patients with triple negative breast cancer randomised to treatment with standard adjuvant chemotherapy alone or to standard adjuvant chemotherapy followed by 1 year of Capecitabine (Xeloda) metronomic therapy.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase III Study of Adjuvant Capecitabine Metronomic Chemotherapy in Triple-negative Operable Breast Cancer|
- disease-free survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]The interim analysis and the final analysis are expected ot occur 18 and 36 months after the end of recruitment.
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Capecitabine 650 mg/m2 bid
capecitabine 650 mg/m2 twice every day for 1 year.
Other Name: Xeloda
No Intervention: Standard treatment
Treatment according to National Comprehensive Cancer Network (NCCN) guideline.
Triple negative breast cancer (TNBC) is an aggressive disease without tumor-specific treatment options. Patients with triple-negative disease had an increased likelihood of distant recurrence and death within 5 years of diagnosis. Median time to distant recurrence was significantly shorter.This study will evaluate the efficacy and safety of the addition of Capecitabine (Xeloda) to standard adjuvant therapy in patients with triple negative breast cancer. Patients will be randomized to receive either standard chemotherapy (according to NCCN guideline), or standard chemotherapy followed by 1 year of metronomic Capecitabine (650mg/m2, twice every day). The anticipated time on study treatment is 6-12 months, and the target sample size is 424 individuals.Disease-free Survival (DFS) will be primary end point.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01112826
|Contact: Yuan Zhong-yu, MDfirstname.lastname@example.org|
|Contact: Wang Xi, MDemail@example.com|
|Sun Yat-sen University, Cancer Center||Recruiting|
|Guangzhou, Guangdong, China, 510060|
|Contact: Yuan Zhong-yu, MD 86-20-87343347 firstname.lastname@example.org|
|Contact: Wang Xi, MD 86-20-62354672 email@example.com|
|Sub-Investigator: Yuan Zhong-yu, MD|
|Study Director:||Yuan Zhong-yu, MD||Sun Yat-sen University|