Low Dose of Metronomic Cyclophosphamide and Capecitabine in Pretreated HER2-negative Metastatic Breast Cancer

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the role of low dose metronomic cyclophosphamide and capecitabine in pretreated metastatic breast cancer.

Detailed Description
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Metronomic chemotherapy has been considered as an effective strategy in metastatic breast cancer. This trial is designed to evaluate the role of low dose metronomic cyclophosphamide and capecitabine in pretreated metastatic breast cancer.

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: metroCX


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females with age between 18 and 80 years old ECOG performance between 0-3 Life expectancy more than 3 months Histological proven unresectable recurrent or advanced HER2-negative breast cancer At least one previous therapy regimen (including endocrine therapy) for metastatic breast cancer;suitable for monotherapy (Neoadjuvant or adjuvant docetaxel should be completed at least one year). At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST1.1) No anticancer therapy within 4 weeks Adequate hematologic, hepatic, and renal function,No serious medical history of heart, lung, liver and kidney Provision of written informed consent prior to any study specific procedures Previous capecitabine is permitted, however, it should be completed at least 6 months. Exclusion Criteria: Pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days of first day of drug dosing, or, if positive, a pregnancy ruled out by ultrasound) Women of child-bearing potential, unwilling to use adequate contraceptive protection during the course of the study Treatment with an investigational product within 4 weeks before the first treatment Symptomatic central nervous system metastases Other active malignancies (including other hematologic malignancies) or other malignancies, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia. Patient having a history of clinically significant cardiovascular, hepatic, respiratory or renal diseases, clinically significant hematological and endocrinal abnormalities, clinically significant neurological or psychiatric conditions Uncontrolled serious infection Patients with bad compliance Patients lack of Dihydropyrimidine Dehydrogenase(DPD)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: metroCX<br>metroCX Cyclophosphamide 50mg PO d1-28; Capecitabine 1500mg PO d1-28; every 28days | Drug: metroCX<br>* cyclophosphamide 50mg PO d1-28 capecitabine 1500mg PO d1-28; every 28days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarker | Relationship of serum VEGF level and efficacy | 6 weeks | 
| Biomarker | Relationship of immuno-marker(CD3,CD4,CD8,etc) and efficacy | 6weeks | 
| Biomarker | Relationship of genetics(genetic polymorphisms) and efficacy | 1 time | 
| Efficacy | Overall Response rate | 6 weeks | 
| Efficacy | Overall Survival | 6 weeks | 
| Safety | Safety（NCI CTCAE v4.0） | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metronomic cyclophosphamide, Metronomic capecitabine, HER2-negative breast cancer