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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02865304
Enrollment
80
Registered
2016-08-12
Start date
2016-12-31
Completion date
2018-12-31
Last updated
2016-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angiogenesis, Breast Cancer

Keywords

metastatic breast cancer, HER-2-negative, endostar

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.

Interventions

DRUGendostar

Sponsors

Fujian Cancer Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
overall response rateone year

Contacts

Primary Contactweiwei huang, doctor
huangstudenth@163.com13763893896

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026