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

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

vinorelbine plus oxaliplatin

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring metastatic triple-negative breast cancer, vinorebine, oxaliplatin

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Fudan University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NVBOX regimen

Arm Description

Vinorelbine plus oxaliplatin

Outcomes

Primary Outcome Measures

progression free survival

Secondary Outcome Measures

overall response rate

overall survival

Safety and Tolerability

Number of Participants with Adverse Events, Degree of Adverse Events according to CTC4.0

genetic polymorphisms

To evaluate the relationship of genetic polymorphisms and efficacy.

Full Information

NCT ID

NCT01528826

First Posted

January 29, 2012

Last Updated

February 7, 2012

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT01528826

Brief Title

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

Acronym

NVBOX

Official Title

A Prospective Phase II Trial of Vinorelbine Plus Oxaliplatin in Pretreated Metastatic Triple-negative Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Unknown status

Study Start Date

December 2011 (undefined)

Primary Completion Date

July 2013 (Anticipated)

Study Completion Date

July 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

metastatic triple-negative breast cancer, vinorebine, oxaliplatin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

NVBOX regimen

Arm Type

Experimental

Arm Description

Vinorelbine plus oxaliplatin

Intervention Type

Drug

Intervention Name(s)

vinorelbine plus oxaliplatin

Intervention Description

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

Primary Outcome Measure Information:

Title

progression free survival

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

overall response rate

Time Frame

6 weeks

Title

overall survival

Time Frame

6 weeks

Title

Safety and Tolerability

Description

Number of Participants with Adverse Events, Degree of Adverse Events according to CTC4.0

Time Frame

6 weeks

Title

genetic polymorphisms

Description

To evaluate the relationship of genetic polymorphisms and efficacy.

Time Frame

6 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Leiping Wang, MD

Phone

+862164175590

Ext

8908

leipingwang@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhonghua Wang, MD

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fudan University Cancer Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Leiping Wang, MD

Phone

+862164175590

leipingwang@163.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

25648299

Citation

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.

Results Reference

derived

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

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