Docetaxel With or Without Metronomic Cyclophosphamide as First Line Chemotherapy in Metastatic Breast Cancer
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Docetaxel and Cyclophosphamide (TC)
Docetaxel (T)
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Metronomic cyclophosphamide, metastatic breast cancer, first line, docetaxel
Eligibility Criteria
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
Sites / Locations
- Fudan University Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TC
T
Arm Description
Docetaxel plus Cyclophosphamide
Docetaxel
Outcomes
Primary Outcome Measures
Progression Free Survival
Secondary Outcome Measures
Biomarker serum VEGF level
Relationship of serum VEGF level and efficacy
Biomarker immuno-marker
Relationship of immuno-marker(CD3,CD4,CD8 ect) and efficacy
Efficacy Overall Response Rate
Overall Response Rate
Efficacy Overall Survival
Overall Survival, OS
Safety
Safety(NCI CTCAE v4.0)
genetic polymorphisms
To evaluate the relationship of genetic polymorphisms and efficacy.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01526499
Brief Title
Docetaxel With or Without Metronomic Cyclophosphamide as First Line Chemotherapy in Metastatic Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2011 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
July 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Metronomic cyclophosphamide, metastatic breast cancer, first line, docetaxel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TC
Arm Type
Experimental
Arm Description
Docetaxel plus Cyclophosphamide
Arm Title
T
Arm Type
Active Comparator
Arm Description
Docetaxel
Intervention Type
Drug
Intervention Name(s)
Docetaxel and Cyclophosphamide (TC)
Intervention Description
Docetaxel 75mg/m2 IVGTT D1 Cyclophosphamide 50mg PO D1-21;every 21days
Intervention Type
Drug
Intervention Name(s)
Docetaxel (T)
Intervention Description
Docetaxel 75mg/m2 IVGTT D1;every 21days
Primary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Biomarker serum VEGF level
Description
Relationship of serum VEGF level and efficacy
Time Frame
6 weeks
Title
Biomarker immuno-marker
Description
Relationship of immuno-marker(CD3,CD4,CD8 ect) and efficacy
Time Frame
6 weeks
Title
Efficacy Overall Response Rate
Description
Overall Response Rate
Time Frame
6 weeks
Title
Efficacy Overall Survival
Description
Overall Survival, OS
Time Frame
6 weeks
Title
Safety
Description
Safety(NCI CTCAE v4.0)
Time Frame
6 weeks
Title
genetic polymorphisms
Description
To evaluate the relationship of genetic polymorphisms and efficacy.
Time Frame
6 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leiping Wang, MD
Phone
+862164175590
Email
leipingwang@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhonghua Wang, MD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Cancer Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leiping Wang, MD
Phone
+862164175590
Ext
8908
Email
leipingwang@163.com
12. IPD Sharing Statement
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Docetaxel With or Without Metronomic Cyclophosphamide as First Line Chemotherapy in Metastatic Breast Cancer
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