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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Angiogenesis Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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endostar; taxane

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.

Group Type EXPERIMENTAL

endostar

Intervention Type DRUG

Interventions

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endostar

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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weiwei huang, doctor

Role: PRINCIPAL_INVESTIGATOR

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