Breast Cancer
Conditions
Keywords
metastatic triple-negative breast cancer, vinorebine, oxaliplatin
Brief summary
The purpose of this study is to evaluate the efficacy and safety of vinorelbine plus oxaliplatin in pretreated metastatic triple-negative breast cancer.
Detailed description
Triple-negative breast cancer is associated with less treatment choices and shorter overall survival. Both vinorebine and oxaliplatin are effective in metastatic breast cancer. The investigators designed this trial to evaluate the combination of these two drugs in pretreated metastatic triple-negative breast cancer.
Interventions
DRUGvinorelbine plus oxaliplatin
Vinorelbine 30mg/m2 IVGTT D1 Oxaliplatin 90mg/m2 IVGTT D1; every 2 weeks
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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 0-2 3. Life expectancy more than 3 months 4. Histological proven unresectable recurrent or advanced breast cancer 5. Triple-negative for estrogen receptor (ER), progestogen receptor (PR), and human epithelial receptor-2 (HER2) by immunohistochemistry (IHC) test. For patients with ER negative, PR negative, Her2 two plus, a negative Her2 gene amplification should be verified with FISH test. Her2 one plus may consider FISH verification. 6. No more than 2 chemotherapy for metastatic breast cancer. 7. At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST1.1) 8. No anticancer therapy within 4 weeks 9. No neuropathy more than grade I 10. Adequate hematologic, hepatic, and renal function,No serious medical history of heart, lung, liver and kidney 11. 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. Previous administration of vinorelbine 9. Patients with bad compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival | 6 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| genetic polymorphisms | 6 weeks | To evaluate the relationship of genetic polymorphisms and efficacy. |
| Safety and Tolerability | 6 weeks | Number of Participants with Adverse Events, Degree of Adverse Events according to CTC4.0 |
| overall response rate | 6 weeks | — |
| overall survival | 6 weeks | — |
Countries
China
Contacts
Primary ContactLeiping Wang, MD
Outcome results
None listed