Clinical trial NCT01112826: Efficacy of Capecitabine Metronomic Chemotherapy to Triple-negative Breast Cancer
Official title: Phase III Study of Adjuvant Capecitabine Metronomic Chemotherapy in Triple-negative Operable Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: triple-negative breast cancer
metronomic chemotherapy
capecitabine (xeloda)
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2010-04-28
Enrollment: 443
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: disease-free survival
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University, Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Yuan Zhong-yu, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.