Efficacy of Capecitabine Metronomic Chemotherapy to Triple-negative Breast Cancer (SYSUCC-001)

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Capecitabine

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.

• Study Type: Interventional
• Enrollment (Actual): 443
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-sen University, Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Capecitabine; Capecitabine 650 mg/m2 bid	Drug: Capecitabine; capecitabine 650 mg/m2 twice every day for 1 year.
No Intervention: Standard treatment; Treatment according to National Comprehensive Cancer Network (NCCN) guideline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
disease-free survival	The final analysis are expected to occur 36 months after the end of recruitment.	36 months

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Study Director: Yuan Zhong-yu, MD, Sun Yat-sen University

Publications and helpful links

General Publications

• Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.
• Wang X, Wang SS, Huang H, Cai L, Zhao L, Peng RJ, Lin Y, Tang J, Zeng J, Zhang LH, Ke YL, Wang XM, Liu XM, Chen QJ, Zhang AQ, Xu F, Bi XW, Huang JJ, Li JB, Pang DM, Xue C, Shi YX, He ZY, Lin HX, An X, Xia W, Cao Y, Guo Y, Su YH, Hua X, Wang XY, Hong RX, Jiang KK, Song CG, Huang ZZ, Shi W, Zhong YY, Yuan ZY; South China Breast Cancer Group (SCBCG). Effect of Capecitabine Maintenance Therapy Using Lower Dosage and Higher Frequency vs Observation on Disease-Free Survival Among Patients With Early-Stage Triple-Negative Breast Cancer Who Had Received Standard Treatment: The SYSUCC-001 Randomized Clinical Trial. JAMA. 2021 Jan 5;325(1):50-58. doi: 10.1001/jama.2020.23370. Erratum In: JAMA. 2022 May 17;327(19):1929.

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2010
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: April 22, 2010
• First Submitted That Met QC Criteria: April 27, 2010
• First Posted (Estimate): April 28, 2010

Study Record Updates

• Last Update Posted (Actual): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 22, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: triple-negative breast cancer; metronomic chemotherapy; capecitabine (xeloda)
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Capecitabine
• Other Study ID Numbers: SYSUCC-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No