NCT01528826

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
Completed

Started Dec 2011

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 8, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

February 8, 2012

Status Verified

February 1, 2012

Enrollment Period

1.6 years

First QC Date

January 29, 2012

Last Update Submit

February 7, 2012

Conditions

Breast Cancer

Keywords

metastatic triple-negative breast cancervinorebineoxaliplatin

Outcome Measures

Primary Outcomes (1)

  • progression free survival

    6 weeks

Secondary Outcomes (4)

  • overall response rate

    6 weeks

  • overall survival

    6 weeks

  • Safety and Tolerability

    6 weeks

  • genetic polymorphisms

    6 weeks

Study Arms (1)

NVBOX regimen

EXPERIMENTAL

Vinorelbine plus oxaliplatin

Drug: vinorelbine plus oxaliplatin

Interventions

vinorelbine plus oxaliplatinDRUG

Vinorelbine 30mg/m2 IVGTT D1 Oxaliplatin 90mg/m2 IVGTT D1; every 2 weeks

NVBOX regimen

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 25648299DERIVED

MeSH Terms

Conditions

Breast NeoplasmsTriple Negative Breast Neoplasms

Interventions

VinorelbineOxaliplatin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Vinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesCoordination ComplexesOrganic Chemicals

Study Officials

  • Zhonghua Wang, MD

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leiping Wang, MD

CONTACT

+862164175590leipingwang@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

January 29, 2012

First Posted

February 8, 2012

Study Start

December 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

February 8, 2012

Record last verified: 2012-02

Locations

CN(1)