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

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

The purpose of this study is to evaluate the efficacy and safety of vinorelbine plus oxaliplatin in pretreated metastatic triple-negative breast cancer.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: vinorelbine plus oxaliplatin

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 Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Fudan University Cancer Center
      • Contact: Leiping Wang, MD; Phone Number: +862164175590; Email: leipingwang@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NVBOX regimen; Vinorelbine plus oxaliplatin	Drug: vinorelbine plus oxaliplatin; Vinorelbine 30mg/m2 IVGTT D1 Oxaliplatin 90mg/m2 IVGTT D1; every 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Zhonghua Wang, MD, Fudan University

Publications and helpful links

General Publications

• Zhang J, Wang L, Wang Z, Hu X, Wang B, Cao J, Lv F, Zhen C, Zhang S, Shao Z. A phase II trial of biweekly vinorelbine and oxaliplatin in second- or third-line metastatic triple-negative breast cancer. Cancer Biol Ther. 2015;16(2):225-32. doi: 10.4161/15384047.2014.986973.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Anticipated): July 1, 2013
• Study Completion (Anticipated): July 1, 2013

Study Registration Dates

• First Submitted: January 29, 2012
• First Submitted That Met QC Criteria: February 7, 2012
• First Posted (Estimate): February 8, 2012

Study Record Updates

• Last Update Posted (Estimate): February 8, 2012
• Last Update Submitted That Met QC Criteria: February 7, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: oxaliplatin; metastatic triple-negative breast cancer; vinorebine
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Oxaliplatin; Vinorelbine
• Other Study ID Numbers: NVBOX