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

Phase 2

• Conditions: Breast Cancer
• Interventions: Drug: vinorelbine plus oxaliplatin

• Registration Number: NCT01528826
• Lead Sponsor: Fudan University

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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-01-29
• Status Verified: 2012-02
• Study First Submitted QC: 2012-02-07
• Last Update Submitted: 2012-02-07
• Study First Posted: 2012-02-08
• Last Update Posted: 2012-02-08
• Primary Completion: 2013-07
• Study Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NVBOX regimen	vinorelbine plus oxaliplatin	Vinorelbine plus oxaliplatin

Primary Outcome Measures

Name	Time	Method
progression free survival	6 weeks

Secondary Outcome Measures

Name	Time	Method
overall response rate	6 weeks
overall survival	6 weeks
Safety and Tolerability	6 weeks	Number of Participants with Adverse Events, Degree of Adverse Events according to CTC4.0
genetic polymorphisms	6 weeks	To evaluate the relationship of genetic polymorphisms and efficacy.

Trial Locations

Locations (1)

Fudan University Cancer Center; 🇨🇳 Shanghai, Shanghai, China