Salvage Chemotherapy of Vinorelbine Plus Oxaliplatin in Metastatic Triple-negative Breast Cancer:a Prospective Trial (NVBOX)
This study is currently recruiting participants.
Verified February 2012 by Fudan University
Sponsor:
Fudan University
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
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 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 June 18, 2013