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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
Fujian Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angiogenesis focused on measuring metastatic breast cancer, HER-2-negative, endostar

Eligibility Criteria

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

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

    First Posted
    May 25, 2016
    Last Updated
    August 11, 2016
    Sponsor
    Fujian Cancer Hospital
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    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

    Learn more about this trial

    The Efficacy and Safety of Endostar Combined With Taxane-based Regimens for HER-2-negative MBC Patients

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