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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01528826
Recruitment Status : Unknown
Verified February 2012 by yanfei Liu, Fudan University.
Recruitment status was:  Recruiting
First Posted : February 8, 2012
Last Update Posted : February 8, 2012
Information provided by (Responsible Party):
yanfei Liu, 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: vinorelbine plus oxaliplatin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Phase II Trial of Vinorelbine Plus Oxaliplatin in Pretreated Metastatic Triple-negative Breast Cancer
Study Start Date : December 2011
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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

Primary Outcome Measures :
  1. progression free survival [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. overall response rate [ Time Frame: 6 weeks ]
  2. overall survival [ Time Frame: 6 weeks ]
  3. Safety and Tolerability [ Time Frame: 6 weeks ]
    Number of Participants with Adverse Events, Degree of Adverse Events according to CTC4.0

  4. genetic polymorphisms [ Time Frame: 6 weeks ]
    To evaluate the relationship of genetic polymorphisms and efficacy.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01528826

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Contact: Leiping Wang, MD +862164175590 ext 8908

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China, Shanghai
Fudan University Cancer Center Recruiting
Shanghai, Shanghai, China, 200032
Contact: Leiping Wang, MD    +862164175590   
Sponsors and Collaborators
Fudan University
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Principal Investigator: Zhonghua Wang, MD Fudan University

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: yanfei Liu, principal investigator, Fudan University Identifier: NCT01528826    
Other Study ID Numbers: NVBOX
First Posted: February 8, 2012    Key Record Dates
Last Update Posted: February 8, 2012
Last Verified: February 2012
Keywords provided by yanfei Liu, Fudan University:
metastatic triple-negative breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action