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

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
yanfei Liu, Fudan University

Tracking Information
First Submitted Date  ICMJE January 29, 2012
First Posted Date  ICMJE February 8, 2012
Last Update Posted Date February 8, 2012
Study Start Date  ICMJE December 2011
Estimated Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2012)
progression free survival [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2012)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Salvage Chemotherapy of Vinorelbine Plus Oxaliplatin in Metastatic Triple-negative Breast Cancer:a Prospective Trial
Official Title  ICMJE A Prospective Phase II Trial of Vinorelbine Plus Oxaliplatin in Pretreated Metastatic Triple-negative Breast Cancer
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Drug: vinorelbine plus oxaliplatin
Vinorelbine 30mg/m2 IVGTT D1 Oxaliplatin 90mg/m2 IVGTT D1; every 2 weeks
Study Arms  ICMJE Experimental: NVBOX regimen
Vinorelbine plus oxaliplatin
Intervention: Drug: vinorelbine plus oxaliplatin
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 7, 2012)
35
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2013
Estimated Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01528826
Other Study ID Numbers  ICMJE NVBOX
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party yanfei Liu, Fudan University
Study Sponsor  ICMJE Fudan University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Zhonghua Wang, MD Fudan University
PRS Account Fudan University
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP