Efficacy of Capecitabine Metronomic Chemotherapy to Triple-negative Breast Cancer (SYSUCC-001)

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.

Triple negative (ER-/PR-/HER2-) 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 (Xeloda) 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 6-12 months, and the target sample size is 424 individuals.Disease-free Survival (DFS) will be primary end point.

• Drug: Capecitabine (Xeloda)
  capecitabine (Xeloda) 650 mg/m2 twice every day for 1 year.
  Other Name: Capecitabine
• Drug: Standard adjuvant chemotherapy
  Standard adjuvant chemotherapy

• Active Comparator: Standard adjuvant chemotherapy
  Standard adjuvant chemotherapy
  Intervention: Drug: Standard adjuvant chemotherapy
• Experimental: Capecitabine (XELODA)
  Standard adjuvant chemotherapy followed by 1 year treatment of metronomic capecitabine
  Interventions:

  • Drug: Capecitabine (Xeloda)
  • Drug: Standard adjuvant chemotherapy

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.