Efficacy of Capecitabine Metronomic Chemotherapy to Triple-negative Breast Cancer

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Capecitabine

• Registration Number: NCT01112826
• Lead Sponsor: Sun Yat-sen University

Brief 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.

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 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 12 months, and the target sample size is 432 individuals.Disease-free Survival (DFS) will be primary end point.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-04-22
• Study Start: 2010-04-23
• Study First Submitted QC: 2010-04-27
• Study First Posted: 2010-04-28
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-22
• Last Update Posted: 2020-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 443

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Capecitabine	Capecitabine	Capecitabine 650 mg/m2 bid

Primary Outcome Measures

Name	Time	Method
disease-free survival	36 months	The final analysis are expected to occur 36 months after the end of recruitment.

Trial Locations

Locations (1)

Sun Yat-sen University, Cancer Center; 🇨🇳 Guangzhou, Guangdong, China