The Efficacy and Safety of Endostar Combined With Taxane-based Regimens for HER-2-negative Metastatic Breast Cancer Patients
Overview
- Phase
- Phase 3
- Intervention
- endostar
- Conditions
- Angiogenesis
- Sponsor
- Fujian Cancer Hospital
- Enrollment
- 80
- Primary Endpoint
- overall response rate
- Last Updated
- 9 years ago
Overview
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.
Investigators
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
Arms & Interventions
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.
Intervention: endostar
Outcomes
Primary Outcomes
overall response rate
Time Frame: one year