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

• ClinicalTrials.gov Identifier: NCT01112826
• Recruitment Status: Completed
• First Posted: April 28, 2010
• Last Update Posted: May 27, 2020
• Sponsor: Sun Yat-sen University
• Information provided by (Responsible Party): Zhong-yu Yuan, Sun Yat-sen University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: Capecitabine	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 443 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase III Study of Adjuvant Capecitabine Metronomic Chemotherapy in Triple-negative Operable Breast Cancer
• Actual Study Start Date: April 23, 2010
• Actual Primary Completion Date: December 31, 2019
• Actual Study Completion Date: December 31, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. disease-free survival [ Time Frame: 36 months ]
   The final analysis are expected to occur 36 months after the end of recruitment.

Eligibility Criteria

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

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.

Contacts and Locations

Locations

China, Guangdong

Sun Yat-sen University, Cancer Center

Guangzhou, Guangdong, China, 510060

Sponsors and Collaborators

Sun Yat-sen University

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Zhong-yu Yuan, MD, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT01112826
• Other Study ID Numbers: SYSUCC-001
• First Posted: April 28, 2010
• Last Update Posted: May 27, 2020
• Last Verified: May 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Zhong-yu Yuan, Sun Yat-sen University:

triple-negative breast cancer; metronomic chemotherapy; capecitabine (xeloda)

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Capecitabine; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents