Efficacy of Capecitabine Metronomic Chemotherapy to Triple-negative Breast Cancer

NCT ID: NCT01112826

Last Updated: 2020-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 443 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-23
• Study Completion Date: 2019-12-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Capecitabine

Capecitabine 650 mg/m2 bid

Group Type: EXPERIMENTAL

Capecitabine

Intervention Type: DRUG

capecitabine 650 mg/m2 twice every day for 1 year.

Standard treatment

Treatment according to National Comprehensive Cancer Network (NCCN) guideline.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Capecitabine

capecitabine 650 mg/m2 twice every day for 1 year.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Zhong-yu Yuan

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yuan Zhong-yu, MD

Role: STUDY_DIRECTOR

Sun Yat-sen University

Locations

Sun Yat-sen University, Cancer Center

Guangzhou, Guangdong, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 34037241 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33300950 (View on PubMed)

Other Identifiers

SYSUCC-001

Identifier Type: -

Identifier Source: org_study_id