Efficacy of Capecitabine Metronomic Chemotherapy to Triple-negative 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.

Sex

Female

Minimum age

18 Years

Maximum age

70 Years

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.

• DERIVEDYuan 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
• DERIVEDHoon 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
• DERIVEDWang 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