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Trial record 1 of 1 for:    NCT01112826
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Efficacy of Capecitabine Metronomic Chemotherapy to Triple-negative Breast Cancer (SYSUCC-001)

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ClinicalTrials.gov Identifier: NCT01112826
Recruitment Status : Completed
First Posted : April 28, 2010
Last Update Posted : May 27, 2020
Information provided by (Responsible Party):
Zhong-yu Yuan, Sun Yat-sen University

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Drug: Capecitabine Phase 3

Detailed Description:
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 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 12 months, and the target sample size is 432 individuals.Disease-free Survival (DFS) will be primary end point.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 443 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Study of Adjuvant Capecitabine Metronomic Chemotherapy in Triple-negative Operable Breast Cancer
Actual Study Start Date : April 23, 2010
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Capecitabine
Capecitabine 650 mg/m2 bid
Drug: Capecitabine
capecitabine 650 mg/m2 twice every day for 1 year.

No Intervention: Standard treatment
Treatment according to National Comprehensive Cancer Network (NCCN) guideline.

Primary Outcome Measures :
  1. disease-free survival [ Time Frame: 36 months ]
    The final analysis are expected to occur 36 months after the end of recruitment.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01112826

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China, Guangdong
Sun Yat-sen University, Cancer Center
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
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Study Director: Yuan Zhong-yu, MD Sun Yat-sen University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zhong-yu Yuan, MD, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01112826    
Other Study ID Numbers: SYSUCC-001
First Posted: April 28, 2010    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Zhong-yu Yuan, Sun Yat-sen University:
triple-negative breast cancer
metronomic chemotherapy
capecitabine (xeloda)
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents