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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zhong-yu Yuan, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01112826
First received: April 22, 2010
Last updated: December 19, 2016
Last verified: December 2016
  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 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
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:


Further study details as provided by Zhong-yu Yuan, Sun Yat-sen University:

Primary Outcome Measures:
  • disease-free survival [ Time Frame: 36 months ]
    The interim analysis and the final analysis are expected ot occur 18 and 36 months after the end of recruitment.


Enrollment: 428
Study Start Date: April 2010
Study Completion Date: December 2016
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Capecitabine
Capecitabine 650 mg/m2 bid
Drug: Capecitabine
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.

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 (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   (Adult, Senior)
Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
China, Guangdong
Sun Yat-sen University, Cancer Center
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Study Director: Yuan Zhong-yu, MD Sun Yat-sen University
  More Information

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: December 19, 2016
Individual Participant Data  
Plan to Share IPD: Yes

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

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 27, 2017