TriangleNCT01112826 · CITED IN SOURCE DOCUMENTS
Efficacy of Capecitabine Metronomic Chemotherapy to Triple-negative Breast Cancer
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2020-05-27
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
No posted result sections were captured. Registered plans do not establish that a treatment works.
Who could take part
- eligibility 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.
- healthy Volunteers
- false
- maximum Age
- 70 Years
- minimum Age
- 18 Years
- sex
- FEMALE
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Capecitabine 650 mg/m2 bid
- intervention Names
- Drug: Capecitabine
- label
- Capecitabine
- type
- EXPERIMENTAL
- description
- Treatment according to National Comprehensive Cancer Network (NCCN) guideline.
- label
- Standard treatment
- type
- NO_INTERVENTION
- interventions
- arm Group Labels
- Capecitabine
- description
- capecitabine 650 mg/m2 twice every day for 1 year.
- name
- Capecitabine
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 443
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- The final analysis are expected to occur 36 months after the end of recruitment.
- measure
- disease-free survival
- time Frame
- 36 months
Full study description
- 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.
- 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.
Source references
- references
- citation
- 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.
- pmid
- 41308674
- type
- DERIVED
- citation
- Hoon 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.
- pmid
- 34037241
- type
- DERIVED
- citation
- Wang 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.
- pmid
- 33300950
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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- ents who have not been treated with preoperative systemic therapy):</p> <div class="pdq-content-list"><ol id="_3071"><li>The <a href="/clinicaltrials/NCT01112826">SYSUCC-001</a> trial (NCT01112826) included 443 women (434 analyzed) with TNBC from 13 Chinese institutions. The women had received adjuvant chemotherapy and
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- preoperative systemic therapy):</p> <div class="pdq-content-list"><ol id="_3071"><li>The <a href="/clinicaltrials/NCT01112826">SYSUCC-001</a> trial (NCT01112826) included 443 women (434 analyzed) with TNBC from 13 Chinese institutions. The women had received adjuvant chemotherapy and were randomly assigned to receive e
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- 2026-09-09T23:21:35.419733+00:00
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- source title
- Breast Cancer Treatment (PDQ®)–Health Professional Version
- source update dates
- context
- Updated: April 25, 2025
- datetime
- 2025-04-25T12:00:00Z
- display
- April 25, 2025
Preserved source evidence · Not medical advice