Breast CancerPhase 3SYSUCC-001NCT01112826
Efficacy of Capecitabine Metronomic Chemotherapy to Triple-negative Breast Cancer
A Phase 3 study testing Capecitabine in people with Breast Cancer, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 443 participants
- Where
- 1 siteChina
- Study dates
- 23 Apr 2010to 31 Dec 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Capecitabine
- Keywords
- triple-negative breast cancer, metronomic chemotherapy, capecitabine (xeloda)
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
capecitabine 650 mg/m2 twice every day for 1 year.
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine | Experimental | Capecitabine 650 mg/m2 bid Receives: Drug: Capecitabine |
| Standard treatment | No intervention | Treatment according to National Comprehensive Cancer Network (NCCN) guideline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free survival
The final analysis are expected to occur 36 months after the end of recruitment.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study start23 Apr 2010
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 443 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhong-yu Yuan, Sun Yat-sen University
- Investigators
- Yuan Zhong-yu, MD, Study director, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112826
- Sponsor's protocol ID
- SYSUCC-001
- Acronym
- SYSUCC-001
- Status last verified
- May 2020
- First submitted
- 22 Apr 2010
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Yuan J, Bi XW, Hua X, Huang H, Cai L, Zhao L, Chen QJ, Chen XX, Wang XL, Lin Y, Zhang AQ, Zhong YY, Xu F, Huang JJ, An X, Shi YX, Wang X, Wang SS, Xue C, Yuan ZY. Metronomic capecitabine as extended adjuvant chemotherapy for early triple-negative breast cancer (SYSUCC-001): updated 10-year outcomes and post-hoc exploratory biomarker analysis from a randomised, phase 3 trial. Lancet Oncol. 2025 Dec;26(12):1575-1583. doi: 10.1016/S1470-2045(25)00545-5.
PubMed 41308674Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.
PubMed 34037241Wang X, Wang SS, Huang H, Cai L, Zhao L, Peng RJ, Lin Y, Tang J, Zeng J, Zhang LH, Ke YL, Wang XM, Liu XM, Chen QJ, Zhang AQ, Xu F, Bi XW, Huang JJ, Li JB, Pang DM, Xue C, Shi YX, He ZY, Lin HX, An X, Xia W, Cao Y, Guo Y, Su YH, Hua X, Wang XY, Hong RX, Jiang KK, Song CG, Huang ZZ, Shi W, Zhong YY, Yuan ZY; South China Breast Cancer Group (SCBCG). Effect of Capecitabine Maintenance Therapy Using Lower Dosage and Higher Frequency vs Observation on Disease-Free Survival Among Patients With Early-Stage Triple-Negative Breast Cancer Who Had Received Standard Treatment: The SYSUCC-001 Randomized Clinical Trial. JAMA. 2021 Jan 5;325(1):50-58. doi: 10.1001/jama.2020.23370.
PubMed 33300950
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Adjuvant Capecitabine Metronomic Chemotherapy in Triple-negative Operable Breast Cancer
- ClinicalTrials.gov ID
- NCT01112826
- Acronym / sponsor ID
- SYSUCC-001 / SYSUCC-001
- Conditions
- Breast Cancer
- Keywords
- triple-negative breast cancer, metronomic chemotherapy, capecitabine (xeloda)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 443 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 23 Apr 2010 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 28 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capecitabine | Experimental | Drug: CapecitabineCapecitabine 650 mg/m2 bid |
| Standard treatment | No intervention | –Treatment according to National Comprehensive Cancer Network (NCCN) guideline. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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);
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capecitabinecapecitabine 650 mg/m2 twice every day for 1 year. | Drug | Capecitabine |
Primary outcome
disease-free survival
Time frame: 36 months
The final analysis are expected to occur 36 months after the end of recruitment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Derived from this study: PubMed 41308674Yuan J, Bi XW, Hua X, Huang H, Cai L, Zhao L, Chen QJ, Chen XX, Wang XL, Lin Y, Zhang AQ, Zhong YY, Xu F, Huang JJ, An X, Shi YX, Wang X, Wang SS, Xue C, Yuan ZY. Metronomic capecitabine as extended adjuvant chemotherapy for early triple-negative breast cancer (SYSUCC-001): updated 10-year outcomes and post-hoc exploratory biomarker analysis from a randomised, phase 3 trial. Lancet Oncol. 2025 Dec;26(12):1575-1583. doi: 10.1016/S1470-2045(25)00545-5.
- Derived from this study: PubMed 34037241Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.
- Derived from this study: PubMed 33300950Wang X, Wang SS, Huang H, Cai L, Zhao L, Peng RJ, Lin Y, Tang J, Zeng J, Zhang LH, Ke YL, Wang XM, Liu XM, Chen QJ, Zhang AQ, Xu F, Bi XW, Huang JJ, Li JB, Pang DM, Xue C, Shi YX, He ZY, Lin HX, An X, Xia W, Cao Y, Guo Y, Su YH, Hua X, Wang XY, Hong RX, Jiang KK, Song CG, Huang ZZ, Shi W, Zhong YY, Yuan ZY; South China Breast Cancer Group (SCBCG). Effect of Capecitabine Maintenance Therapy Using Lower Dosage and Higher Frequency vs Observation on Disease-Free Survival Among Patients With Early-Stage Triple-Negative Breast Cancer Who Had Received Standard Treatment: The SYSUCC-001 Randomized Clinical Trial. JAMA. 2021 Jan 5;325(1):50-58. doi: 10.1001/jama.2020.23370.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuan Zhong-yu, MD study director
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Capecitabine in people with Breast Cancer, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease-free survival (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01112826, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2020.