Overview

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.