Efficacy of Capecitabine Metronomic Chemotherapy to Triple-negative Breast Cancer

• Status: Completed
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Capecitabine

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.