The Efficacy and Safety of Endostar Combined With Taxane-based Regimens for HER-2-negative MBC Patients
Primary Purpose
Angiogenesis, Breast Cancer
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
endostar
Sponsored by
About this trial
This is an interventional treatment trial for Angiogenesis focused on measuring metastatic breast cancer, HER-2-negative, endostar
Eligibility Criteria
Inclusion Criteria:
- women with ages between 18-70 years with histologically confirmed MBC documented as HER-2-negative
Exclusion Criteria:
- cannot tolerated chemotherapy
- cardiac insufficiency
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
endostar; taxane
Arm Description
Endostar was administered at 7.5 mg/m2, d1-14, q21d and was continued until progressive disease, unacceptable toxicity, consent withdrawal, or completion of 24 months. In the same time,Taxane-based chemotherapy was continued until progressive disease, unacceptable toxicity, consent withdrawal, or up to 8 cycles.
Outcomes
Primary Outcome Measures
overall response rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02865304
Brief Title
The Efficacy and Safety of Endostar Combined With Taxane-based Regimens for HER-2-negative MBC Patients
Official Title
The Efficacy and Safety of Endostar Combined With Taxane-based Regimens for HER-2-negative Metastatic Breast Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujian Cancer Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the present study was to prospectively evaluate the efficacy and safety of endostar, a recombinant product of endostatin, combined with taxane-based regimens for HER-2 negative metastatic breast cancer (MBC) patients.
Detailed Description
Endostar is a recombinant product of endostatin, which is an endogenous inhibitor of angiogenesis. Animal studies have shown that endostatin is capable of blocking the proliferation and organization of endothelial cells into new blood vessels in vitro and inhibiting angiogenesis and growth of both primary tumors and secondary metastasis. Regarding breast cancer, in vivo studies showed that the combination of paclitaxel and P125A-endostatin inhibited mammary cancer growth, delayed the onset of multifocal mammary adenocarcinomas, decreased tumor angiogenesis, increased the survival of treated mice in the prevention model, and inhibited lung and lymph node metastasis in the intervention model. Moreover, in a prospective, randomized, controlled, phase II neoadjuvant trial, the combination of rh-endostatin with chemotherapy produced a higher tumor response rate without increasing toxicity in breast cancer patients. Considering these promising data, this prospective study was conducted to evaluate the efficacy and safety of endostar combined with taxane-based regimens for HER-2-negative MBC patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angiogenesis, Breast Cancer
Keywords
metastatic breast cancer, HER-2-negative, endostar
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
endostar; taxane
Arm Type
Experimental
Arm Description
Endostar was administered at 7.5 mg/m2, d1-14, q21d and was continued until progressive disease, unacceptable toxicity, consent withdrawal, or completion of 24 months. In the same time,Taxane-based chemotherapy was continued until progressive disease, unacceptable toxicity, consent withdrawal, or up to 8 cycles.
Intervention Type
Drug
Intervention Name(s)
endostar
Primary Outcome Measure Information:
Title
overall response rate
Time Frame
one year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women with ages between 18-70 years with histologically confirmed MBC documented as HER-2-negative
Exclusion Criteria:
cannot tolerated chemotherapy
cardiac insufficiency
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
weiwei huang, doctor
Phone
13763893896
Email
huangstudenth@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
weiwei huang, doctor
Organizational Affiliation
Department of Medical Oncology, Fujian Provincial Cancer Hospital, The Teaching Hospital of Fujian Medical University, The Teaching Hospital of Fujian University of Traditional Chinese Medicine, Fuzhou 350014, China
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Efficacy and Safety of Endostar Combined With Taxane-based Regimens for HER-2-negative MBC Patients
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