Trials / Unknown
UnknownNCT02865304
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
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- Fujian Cancer Hospital · Other Government
- Sex
- Female
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | endostar |
Timeline
- Start date
- 2016-12-01
- Primary completion
- 2017-12-01
- Completion
- 2018-12-01
- First posted
- 2016-08-12
- Last updated
- 2016-08-12
Source: ClinicalTrials.gov record NCT02865304. Inclusion in this directory is not an endorsement.