Status:
UNKNOWN
Docetaxel With or Without Metronomic Cyclophosphamide as First Line Chemotherapy in Metastatic Breast Cancer
Lead Sponsor:
Fudan University
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01526499
Start Date
December 1 2011
End Date
July 1 2013
Last Update
February 7 2012
Active Locations (1)
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1
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China, 200032