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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2012 by yanfei Liu, Fudan University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01528826
First Posted: February 8, 2012
Last Update Posted: February 8, 2012
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.
Information provided by (Responsible Party):
yanfei Liu, Fudan University
  Purpose
The purpose of this study is to evaluate the efficacy and safety of vinorelbine plus oxaliplatin in pretreated metastatic triple-negative breast cancer.

Condition Intervention Phase
Breast Cancer Drug: vinorelbine plus oxaliplatin Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by yanfei Liu, Fudan University:

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

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

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


Estimated Enrollment: 35
Study Start Date: December 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NVBOX regimen
Vinorelbine plus oxaliplatin
Drug: vinorelbine plus oxaliplatin
Vinorelbine 30mg/m2 IVGTT D1 Oxaliplatin 90mg/m2 IVGTT D1; every 2 weeks

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01528826


Contacts
Contact: Leiping Wang, MD +862164175590 ext 8908 leipingwang@163.com

Locations
China, Shanghai
Fudan University Cancer Center Recruiting
Shanghai, Shanghai, China, 200032
Contact: Leiping Wang, MD    +862164175590    leipingwang@163.com   
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Zhonghua Wang, MD Fudan University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: yanfei Liu, principal investigator, Fudan University
ClinicalTrials.gov Identifier: NCT01528826     History of Changes
Other Study ID Numbers: NVBOX
First Submitted: January 29, 2012
First Posted: February 8, 2012
Last Update Posted: February 8, 2012
Last Verified: February 2012

Keywords provided by yanfei Liu, Fudan University:
metastatic triple-negative breast cancer
vinorebine
oxaliplatin

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Oxaliplatin
Vinorelbine
Vinblastine
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action