Breast Cancer
Conditions
Keywords
Metronomic cyclophosphamide, metastatic breast cancer, first line, docetaxel
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.
Interventions
DRUGDocetaxel and Cyclophosphamide (TC)
Docetaxel 75mg/m2 IVGTT D1 Cyclophosphamide 50mg PO D1-21;every 21days
DRUGDocetaxel (T)
Docetaxel 75mg/m2 IVGTT D1;every 21days
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Females with age between 18 and 70 years old 2. ECOG performance between 0-1 3. Life expectancy more than 3 months 4. Histological proven unresectable recurrent or advanced breast cancer 5. No previous chemotherapy for metastatic breast cancer;suitable for monotherapy (Neoadjuvant or adjuvant docetaxel should be completed at least one year). 6. At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST1.1) 7. No anticancer therapy within 4 weeks 8. Adequate hematologic, hepatic, and renal function,No serious medical history of heart, lung, liver and kidney 9. Provision of written informed consent prior to any study specific procedures
Exclusion criteria
1. 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) 2. Women of child-bearing potential, unwilling to use adequate contraceptive protection during the course of the study 3. Treatment with an investigational product within 4 weeks before the first treatment 4. Symptomatic central nervous system metastases 5. Other active malignancies (including other hematologic malignancies) or other malignancies, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia. 6. 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 7. Uncontrolled serious infection 8. Patients with bad compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival | 6 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biomarker serum VEGF level | 6 weeks | Relationship of serum VEGF level and efficacy |
| Biomarker immuno-marker | 6 weeks | Relationship of immuno-marker(CD3,CD4,CD8 ect) and efficacy |
| genetic polymorphisms | 6 weeks | To evaluate the relationship of genetic polymorphisms and efficacy. |
| Efficacy Overall Survival | 6 weeks | Overall Survival, OS |
| Safety | 6 weeks | Safety（NCI CTCAE v4.0） |
| Efficacy Overall Response Rate | 6 weeks | Overall Response Rate |
Countries
China
Contacts
Primary ContactLeiping Wang, MD
Outcome results
None listed