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Phase III Study of Adjuvant Capecitabine Metronomic Chemotherapy in Triple-negative Operable Breast Cancer

Phase 3
18 Years
70 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Phase III Study of Adjuvant Capecitabine Metronomic Chemotherapy in Triple-negative Operable Breast Cancer

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.

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

disease-free survival

Outcome Description:

The interim analysis and the final analysis are expected ot occur 18 and 36 months after the end of recruitment.

Outcome Time Frame:

36 months

Safety Issue:


Principal Investigator

Yuan Zhong-yu, MD

Investigator Role:

Study Director

Investigator Affiliation:

Sun Yat-sen University


United States: Institutional Review Board

Study ID:




Start Date:

April 2010

Completion Date:

June 2014

Related Keywords:

  • Breast Cancer
  • triple-negative breast cancer
  • metronomic chemotherapy
  • capecitabine (xeloda)
  • Breast Neoplasms