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

This study is currently recruiting participants.
Verified April 2013 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: April 9, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Drug: Capecitabine (Xeloda)
Drug: Standard adjuvant chemotherapy
 Phase 3

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 424
Study Start Date: April 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard adjuvant chemotherapy
Standard adjuvant chemotherapy
 Drug: Standard adjuvant chemotherapy
Standard adjuvant chemotherapy
Experimental: Capecitabine (XELODA)
Standard adjuvant chemotherapy followed by 1 year treatment of metronomic capecitabine
 Drug: Capecitabine (Xeloda)
capecitabine (Xeloda) 650 mg/m2 twice every day for 1 year.
Other Name: Capecitabine
Drug: Standard adjuvant chemotherapy
Standard adjuvant chemotherapy

Detailed Description:

Triple negative (ER-/PR-/HER2-) 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01112826

Contacts
Contact: Yuan Zhong-yu, MD 86-20-87343347 yuanzhygz@163.com
Contact: Wang Xi, MD 86-20-62345782 wangxi@sysucc.org.cn

Locations
China, Guangdong
Sun Yat-sen University, Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Yuan Zhong-yu, MD     86-20-87343347     yuanzhygz@163.com    
Contact: Wang Xi, MD     86-20-62354672     wangxi@sysucc.org.cn    
Sub-Investigator: Yuan Zhong-yu, MD            
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Study Director: Yuan Zhong-yu, MD Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Zhong-yu Yuan, MD, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01112826     History of Changes
Other Study ID Numbers: SYSUCC-001
Study First Received: April 22, 2010
Last Updated: April 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Sun Yat-sen University:
triple-negative breast cancer
metronomic chemotherapy
capecitabine (xeloda)

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Adjuvants, Immunologic
Capecitabine
Fluorouracil
Immunologic Factors
 Physiological Effects of Drugs
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents

ClinicalTrials.gov processed this record on May 23, 2013