Efficacy of Capecitabine Metronomic Chemotherapy to Triple-negative Breast Cancer (SYSUCC-001)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Sun Yat-sen University
Sponsor:
Information provided by (Responsible Party):
Zhong-yu Yuan, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01112826
First received: April 22, 2010
Last updated: February 12, 2015
Last verified: February 2015

April 22, 2010
February 12, 2015
April 2010
December 2015   (final data collection date for primary outcome measure)
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.
disease-free survival [ Time Frame: 28 months ] [ Designated as safety issue: No ]
The interim analysis and the final analysis are expected ot occur 12 and 28 months after the end of recruitment.
Complete list of historical versions of study NCT01112826 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Efficacy of Capecitabine Metronomic Chemotherapy to Triple-negative Breast Cancer
Phase III Study of Adjuvant Capecitabine Metronomic Chemotherapy in Triple-negative Operable Breast Cancer

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
Drug: Capecitabine
capecitabine 650 mg/m2 twice every day for 1 year.
Other Name: Xeloda
  • Experimental: Capecitabine
    Capecitabine 650 mg/m2 bid
    Intervention: Drug: Capecitabine
  • No Intervention: Standard treatment
    Treatment according to National Comprehensive Cancer Network (NCCN) guideline.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
424
December 2015
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must be >=18 years of age;
  • The patients must be Operable primary invasive breast cancer;
  • Definitive loco-regional surgery must be completed;
  • Primary tumor centrally confirmed as triple negative;
  • Operable node-positive (or node-negative with tumor diameter ≥ 0.5cm);
  • Chest, abdominal, bone imaging performed with 3 months prior to randomization must not reveal the presence of distant spread;
  • There are normal organ function, including bone marrow function, renal function, liver function, and cardiac function;
  • All patients must have signed and dated an informed consent form.

Exclusion Criteria:

  • Patients with bilateral breast cancer, inflammatory carcinomas;
  • Patients with positive supraclavicular or internal mammary lymph node;
  • Previous breast cancer history;
  • Any previous malignancy exceptions for carcinoma of the cervix, squamous carcinoma of the skin, or basal cell carcinoma of the skin;
  • Pregnant or breast-feeding women;
  • Women who are unwilling to agree to use an effective non-hormonal method of contraception during the treatment period of Xeloda;
  • Any sex hormonal therapy;
  • Malabsorption syndrome.
Female
18 Years to 70 Years
No
Contact: Yuan Zhong-yu, MD 86-20-87343347 yuanzhygz@163.com
Contact: Wang Xi, MD 86-20-62345782 wangxi@sysucc.org.cn
China
 
NCT01112826
SYSUCC-001
Yes
Zhong-yu Yuan, Sun Yat-sen University
Sun Yat-sen University
Not Provided
Study Director: Yuan Zhong-yu, MD Sun Yat-sen University
Sun Yat-sen University
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP