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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02865304
Other study ID # FJOC-001
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received May 25, 2016
Last updated August 11, 2016
Start date December 2016
Est. completion date December 2018

Study information

Verified date August 2016
Source Fujian Cancer Hospital
Contact weiwei huang, doctor
Phone 13763893896
Email huangstudenth@163.com
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date December 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
endostar


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Fujian Cancer Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary overall response rate one year No
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