Salvage Chemotherapy of Vinorelbine Plus Oxaliplatin in Metastatic Triple-negative Breast Cancer:a Prospective Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Phase II Trial of Vinorelbine Plus Oxaliplatin in Pretreated Metastatic Triple-negative Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: vinorelbine plus oxaliplatin


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 0-2 Life expectancy more than 3 months Histological proven unresectable recurrent or advanced breast cancer 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. No more than 2 chemotherapy for metastatic breast cancer. At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST1.1) No anticancer therapy within 4 weeks No neuropathy more than grade I 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 Previous administration of vinorelbine 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NVBOX regimen<br>Vinorelbine plus oxaliplatin | Drug: vinorelbine plus oxaliplatin<br>* Vinorelbine 30mg/m2 IVGTT D1 Oxaliplatin 90mg/m2 IVGTT D1; every 2 weeks<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 |
| --- | --- | --- |
| overall response rate |  | 6 weeks | 
| overall survival |  | 6 weeks | 
| Safety and Tolerability | Number of Participants with Adverse Events, Degree of Adverse Events according to CTC4.0 | 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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metastatic triple-negative breast cancer, vinorebine, oxaliplatin