Docetaxel With or Without Metronomic Cyclophosphamide as First Line Chemotherapy in 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 metronomic cyclophosphamide in addition to docetaxel in first line therapy in metastatic breast cancer.

Detailed Description
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Metronomic chemotherapy has been considered as an effective strategy for metastatic breast cancer. This trial is designed to evaluate the role of metronomic cyclophosphamide in addition to docetaxel in first line therapy in metastatic breast cancer.

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Docetaxel and Cyclophosphamide (TC)
* Drug: Docetaxel (T)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females with age between 18 and 70 years old ECOG performance between 0-1 Life expectancy more than 3 months Histological proven unresectable recurrent or advanced breast cancer No previous chemotherapy 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TC<br>Docetaxel plus Cyclophosphamide | Drug: Docetaxel and Cyclophosphamide (TC)<br>* Docetaxel 75mg/m2 IVGTT D1 Cyclophosphamide 50mg PO D1-21;every 21days<br>|
| Active Comparator: T<br>Docetaxel | Drug: Docetaxel (T)<br>* Docetaxel 75mg/m2 IVGTT D1;every 21days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarker serum VEGF level | Relationship of serum VEGF level and efficacy | 6 weeks | 
| Biomarker immuno-marker | Relationship of immuno-marker(CD3,CD4,CD8 ect) and efficacy | 6 weeks | 
| Efficacy Overall Response Rate | Overall Response Rate | 6 weeks | 
| Efficacy Overall Survival | Overall Survival, OS | 6 weeks | 
| Safety | Safety（NCI CTCAE v4.0） | 6 weeks | 
| genetic polymorphisms | To evaluate the relationship of genetic polymorphisms and efficacy. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metronomic cyclophosphamide, metastatic breast cancer, first line, docetaxel