Completed

SYSUCC-001Phase III Study of Adjuvant Capecitabine Metronomic Chemotherapy in Triple-negative Operable Breast Cancer

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What is being tested

Capecitabine

Drug
Who is being recruted

Breast Diseases+4

+ Breast Neoplasms

+ Neoplasms

From 18 to 70 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: April 2010
See protocol details

Summary

Principal SponsorSun Yat-sen University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 23, 2010

Actual date on which the first participant was enrolled.

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.

Official TitlePhase III Study of Adjuvant Capecitabine Metronomic Chemotherapy in Triple-negative Operable Breast Cancer
NCT01112826
Principal SponsorSun Yat-sen University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

443 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesBreast NeoplasmsNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesTriple Negative Breast Neoplasms

Criteria

8 inclusion criteria required to participate
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;
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8 exclusion criteria prevent from participating
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;
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Capecitabine 650 mg/m2 bid

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Sun Yat-sen University, Cancer Center

Guangzhou, ChinaOpen Sun Yat-sen University, Cancer Center in Google Maps
CompletedOne Study Center