Metronomic Chemotherapy of Capecitabine After Standard Adjuvant Chemotherapy in Operable Triple Negative Breast Cancer (MACRO)

A Multi-center, III Phase，Randomized Controlled Clinical Study of Capecitabine Metronomic Chemotherapy After Standard Adjuvant Chemotherapy in Operable Triple Negative Breast Cancer

A Multi-center, III Phase,Randomized Controlled Clinical Study of Capecitabine Metronomic Chemotherapy After Standard Adjuvant Chemotherapy in Operable Triple Negative Breast Cancer

Study Overview

• Status: Unknown
• Conditions: Breast Cancer; Triple Negative Breast Cancer; Capecitabine

Detailed Description

Capecitabine comes as a tablet to take by mouth. It is usually taken twice a day (in the morning and in the evening) for 2 weeks, followed by a 1 week break before repeating the next dosage cycle. In this study, capecitabine will be prescribed as dosage of 900mg/m2, and maintain for a whole year after the standard treatment in operable triple negative breast cancer patients. DFS is set as the primary outcome, OS and DDFS are also observed as the secondary outcomes. Statistical analysis are made to see whether this metronomic therapy of capecitabine ( 900mg/m2) will bring benefit to any of the iterms above.

• Study Type: Observational
• Enrollment (Anticipated): 340

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Xijing Hospital ，Fourth Military Medical University
      • Contact: Chen Cong, Master; Phone Number: +86-136-4929-4730; Email: congcongfeiyang@126.com
      • Contact: Nanlin Li, Doctor; Phone Number: +86-137-0911-3279; Email: nanlin-74@163.com

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

Breast cancer patients of vascular endocrine surgery department in Xijing Hospital

Description

Inclusion Criteria:

• Female;
• aged 18 - 70 years old;
• Histological confirmed with unilateral invasive carcinoma (all pathological types are applicable);
• Newly diagnosed conditions allowing direct surgery without any absolute contraindication for surgery;
• No mass or microscopic tumor residue after surgery resection;
• Initiate adjuvant chemotherapy within 30 days after surgery;
• Axillary lymph node positive (including the sentinel lymph node positive and lymph node positive after axillary dissection), for example, axillary lymph node negative requires that primary tumor size must be greater than 1cm;
• Definite reports on ER/PR(progesterone receptor)/Her2 receptor showing all ER/PR/Her2 negative (specific definitions: immunohistochemical detection of ER <10% tumor cells is defined as ER negative, PR <10% positive tumor cells is defined as PR-negative, Her2 is 0~1+ or 2+ but determined negative via FISH or CISH detected (no amplification) is defined as Her2 negative);
• No relevant clinical or imaging evidence of metastasis showing in the preoperative examination (M0);
• Without peripheral neuropathy;
• ECOG performance score is 0 or 1;
• Postoperative recovery was good and an interval of at least one week since the surgery is necessary;
• White blood cell count> 4 × 10^9/l, neutrophil count> 2 × 10^9/l, platelet count> 100 × 10^9/l and hemoglobin 9g/dl);
• ASAT and ALAT <1.5 folds of the upper limit of normal values, alkaline phosphatase <2.5 folds of the upper limit of normal values, total bilirubin <1.5 folds of the upper limit of normal values;
• Serum creatinine <1.5 folds of the upper limit of normal value;
• Women at childbearing age should take contraception measures during treatment;
• Cardiac function: echocardiographic examination showed LEVF> 50%;
• Informed consent form signed.

Exclusion Criteria:

• Bilateral breast cancer or carcinoma in situ (DCIS / LCIS);
• Metastasis at any location;
• Any tumor > T4a (UICC1987) (accompanied by skin involvement, lump adhesion and fixation, inflammatory breast cancer);
• Any of ER, PR or Her-2 is positive;
• Contralateral breast clinically or radiologically suspected to be malignant but not confirmed which needs a biopsy;
• Previous neoadjuvant therapy, including chemotherapy, radiotherapy and hormone therapy;
• Previously suffering from malignant tumors (except for basal cell carcinoma and cervical carcinoma in situ), including contralateral breast cancer;
• Already enrolled into other clinical trials;
• Severe systemic disease and/or uncontrollable infection, unable to be enrolled in this study LEVF <50% (echocardiography);
• Suffering from severe cardiovascular and cerebrovascular diseases within six months before the randomization (such as: unstable angina, chronic heart failure, uncontrollable high blood pressure > 150/90mmHg, myocardial infarction or brain vascular accident);
• Known allergic to taxane and anthracycline agents;
• Women at childbearing age refuse to take contraception measures during the treatment and 8 weeks after completion of treatment;
• Pregnant and breast-feeding women;
• Pregnancy test showed positive results before drug administration after enrolling in to the study; With mental illness and cognitive impairment, unable to understand trial protocol and side effects and complete trial protocol and follow-ups (systematic evaluation is required before recruiting into this study);
• Without personal freedom and independent civil capacity.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS（Progression-free survival）	PFS was defined as the time from the date of randomization until the date of disease progression at any site including distant metastasis or second primary tumors or death， assessed up to 3 years	Progression-free survival：time from the date of randomization until the date of disease progression，assessed up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	OS was defined as the time from the date of randomization until the date of any death occurred	time from the date of randomization until the date of any death occurred
DDFS		time from the date of randomization until the date of any disease occurred

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Collaborators: Roche Pharma AG
• Investigators: Principal Investigator: Nanlin Li, Doctor, Air Force Military Medical University, China

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: November 26, 2013
• First Submitted That Met QC Criteria: December 9, 2013
• First Posted (Estimate): December 16, 2013

Study Record Updates

• Last Update Posted (Estimate): November 13, 2014
• Last Update Submitted That Met QC Criteria: November 11, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Breast Cancer; Capecitabine; Triple Negative Breast CancerTNBC（TNBC）
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms
• Other Study ID Numbers: TPYS-01