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

Phase 3

• Conditions: Breast Cancer; Angiogenesis
• Interventions: Drug: endostar

• Registration Number: NCT02865304
• Lead Sponsor: Fujian Cancer Hospital

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.

Study Timeline

• Study First Submitted: 2016-05-25
• Status Verified: 2016-08
• Study First Submitted QC: 2016-08-11
• Last Update Submitted: 2016-08-11
• Study First Posted: 2016-08-12
• Last Update Posted: 2016-08-12
• Study Start: 2016-12
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• women with ages between 18-70 years with histologically confirmed MBC documented as HER-2-negative

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Exclusion Criteria

• cannot tolerated chemotherapy
• cardiac insufficiency

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
endostar; taxane	endostar	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.

Primary Outcome Measures

Name	Time	Method
overall response rate	one year