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
Information provided by (Responsible Party):
yanfei Liu, Fudan University
First received: January 29, 2012
Last updated: February 7, 2012
Last verified: February 2012
The purpose of this study is to evaluate the efficacy and safety of vinorelbine plus oxaliplatin in pretreated metastatic triple-negative breast cancer.
Drug: vinorelbine plus oxaliplatin
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Prospective Phase II Trial of Vinorelbine Plus Oxaliplatin in Pretreated Metastatic Triple-negative Breast Cancer
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||July 2013 (Final data collection date for primary outcome measure)
Experimental: NVBOX regimen
Vinorelbine plus oxaliplatin
Drug: vinorelbine plus oxaliplatin
Vinorelbine 30mg/m2 IVGTT D1 Oxaliplatin 90mg/m2 IVGTT D1; every 2 weeks
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.
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Females with age between 18 and 70 years old
- ECOG performance between 0-2
- Life expectancy more than 3 months
- Histological proven unresectable recurrent or advanced breast cancer
- 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.
- No more than 2 chemotherapy for metastatic breast cancer.
- At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST1.1)
- No anticancer therapy within 4 weeks
- No neuropathy more than grade I
- Adequate hematologic, hepatic, and renal function,No serious medical history of heart, lung, liver and kidney
- Provision of written informed consent prior to any study specific procedures
- 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)
- Women of child-bearing potential, unwilling to use adequate contraceptive protection during the course of the study
- Treatment with an investigational product within 4 weeks before the first treatment
- Symptomatic central nervous system metastases
- Other active malignancies (including other hematologic malignancies) or other malignancies, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia.
- 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
- Uncontrolled serious infection
- Previous administration of vinorelbine
- Patients with bad compliance
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
|Fudan University Cancer Center
|Shanghai, Shanghai, China, 200032 |
|Contact: Leiping Wang, MD +862164175590 firstname.lastname@example.org |
||Zhonghua Wang, MD
No publications provided
||yanfei Liu, principal investigator, Fudan University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 29, 2012
||February 7, 2012
||China: Ethics Committee
Keywords provided by Fudan University:
metastatic triple-negative breast cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 26, 2015
Triple Negative Breast Neoplasms
Neoplasms by Site
Antineoplastic Agents, Phytogenic