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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Fudan University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
yanfei Liu, Fudan University
ClinicalTrials.gov Identifier:
NCT01528826
First received: January 29, 2012
Last updated: February 7, 2012
Last verified: February 2012
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Fudan University:

Primary Outcome Measures:
  • progression free survival [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall response rate [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Safety and Tolerability [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Number of Participants with Adverse Events, Degree of Adverse Events according to CTC4.0

  • genetic polymorphisms [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 70 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: yanfei Liu, principal investigator, Fudan University
ClinicalTrials.gov Identifier: NCT01528826     History of Changes
Other Study ID Numbers: NVBOX
Study First Received: January 29, 2012
Last Updated: February 7, 2012
Health Authority: China: Ethics Committee

Keywords provided by 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
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014