Efficacy of Capecitabine Metronomic Chemotherapy to Triple-negative Breast Cancer
Information source: Sun Yat-sen University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: Capecitabine (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Sun Yat-sen University Official(s) and/or principal investigator(s): Yuan Zhong-yu, MD, Study Director, Affiliation: Sun Yat-sen University
Overall contact: Yuan Zhong-yu, MD, Phone: 86-20-87343347, Email: yuanzhygz@163.com
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.
Clinical Details
Official title: Phase III Study of Adjuvant Capecitabine Metronomic Chemotherapy in Triple-negative Operable Breast Cancer
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: disease-free survival
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 (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.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Female.
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.
Locations and Contacts
Yuan Zhong-yu, MD, Phone: 86-20-87343347, Email: yuanzhygz@163.com
Sun Yat-sen University, Cancer Center, Guangzhou, Guangdong 510060, China; Recruiting Yuan Zhong-yu, MD, Phone: 86-20-87343347, Email: yuanzhygz@163.com Wang Xi, MD, Phone: 86-20-62354672, Email: wangxi@sysucc.org.cn Yuan Zhong-yu, MD, Sub-Investigator
Additional Information
Starting date: April 2010
Last updated: February 12, 2015
|