Efficacy of Capecitabine Metronomic Chemotherapy to Triple-negative Breast Cancer

Conditions

Breast Cancer

Keywords

triple-negative breast cancer, metronomic chemotherapy, capecitabine (xeloda)

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.

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.

2025-12-011 citations

10.1016/s1470-2045(25)00545-5

Predict the benefit of metronomic capecitabine maintenance in early-stage triple-negative breast cancer: Results from the SYSUCC-001 study.

Zhongyu Yuan, Xin Hua, Wang‐Zhong Li, Heng Huang, Li Cai et al. (21 authors)

Journal of Clinical Oncology2021-05-203 citations

10.1200/jco.2021.39.15_suppl.521

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

Xi Wang, Shusen Wang, Heng Huang, Li Cai, Li Zhao et al. (39 authors)

JAMA2020-12-10214 citations

10.1001/jama.2020.23370

Phase III trial of metronomic capecitabine maintenance after standard treatment in operable triple-negative breast cancer (SYSUCC-001).

Xi Wang, Shusen Wang, Heng Huang, Cai Li, Roujun Peng et al. (20 authors)

Journal of Clinical Oncology2020-05-2017 citations

10.1200/jco.2020.38.15_suppl.507

Interventions

DRUGCapecitabine

capecitabine 650 mg/m2 twice every day for 1 year.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame	Description
disease-free survival	36 months	The final analysis are expected to occur 36 months after the end of recruitment.

Countries

China

Outcome results

None listed