Salvage Chemotherapy of Vinorelbine Plus Oxaliplatin in Metastatic Triple-negative Breast Cancer:a Prospective Trial
NCT ID: NCT01528826
Last Updated: 2012-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
35 participants
INTERVENTIONAL
2011-12-31
2013-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Vinorelbine Plus Apatinib Versus Vinorelbine in Advanced Triple-Negative Breast Cancer
NCT03254654
Combined Use of Apatinib Mesylate and Vinorelbine Versus Single Use of Vinorelbine in Triple-negative Breast Cancer
NCT03932526
Neoadjuvant Platinum-based Chemoradiation Therapy for Locally Advanced Triple Negative Breast Cancer
NCT01167192
NX in Luminal B Breast Cancer Patients After Neoadjuvant Chemotherapy
NCT04307147
Sequential Versus Simultaneous Use of Vinorelbine and Capecitabine in Patients With Metastatic Breast Cancer (MBC)
NCT00629148
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
NVBOX regimen
Vinorelbine plus oxaliplatin
vinorelbine plus oxaliplatin
Vinorelbine 30mg/m2 IVGTT D1 Oxaliplatin 90mg/m2 IVGTT D1; every 2 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
vinorelbine plus oxaliplatin
Vinorelbine 30mg/m2 IVGTT D1 Oxaliplatin 90mg/m2 IVGTT D1; every 2 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
70 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fudan University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
yanfei Liu
principal investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zhonghua Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fudan University Cancer Center
Shanghai, Shanghai Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NVBOX
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.