Early Primary Breast Cancer Clinical Trial
Official title:
Contrast-enhanced Ultrasound in Neoadjuvant Chemotherapy of Breast Cancer
Effect of the contrast-enhanced diagnostic ultrasound during neoadjuvant chemotherapy of breast cancer on the achieved tumor size reduction and tolerability of chemotherapy
The 5-year survival rate of breast cancer patients is decreasing in the advanced, metastatic
stage from 99% to 26%. Therefore an optimization of the therapy of advanced breast cancer is
urgently needed.
To increase the echogenicity of the blood in the ultrasound, microbubbles were developed
working as stable, biocompatible contrast agent in ultrasound. Such a clinically approved
ultrasound contrast agent is SonoVue® (Bracco International B.V., Amsterdam). SonoVue® is
approved by the European Medicines Agency (EMA) (approval number EU/1/01/177/002) for the
visualization of focal vascularization lesions of the liver and breast within Doppler
sonography and is applied in breast cancer patients primarily for the purpose of diagnosis as
well as to evaluate the response to the neoadjuvant used chemotherapy.
Animal studies using the contrast enhanced ultrasound have shown that the administration of
this contrast agent increases the penetration and accumulation of drugs in the tumor as well
as the permeability of the blood-brain barrier resulting in a precise and effective drug
distribution. In the tumor animal model it could be shown that a combined treatment with
chemotherapy and contrast enhanced ultrasound results in a decreased tumor growth and a
prolonged survival. Patients with inoperable pancreatic cancer showed a reduced tumor growth
and better tolerability of chemotherapy when administrating the contrast enhanced diagnostic
ultrasound during palliative chemotherapy. This could be due to the better tumor response,
but also due to the more targeted chemotherapy distribution.
The purpose of this study is to examine whether the use of the contrast enhanced diagnostic
ultrasound during neoadjuvant chemotherapy results in an increased tumor regression in
comparison to native ultrasound. It is an Investigator Initiated Trial and is funded by
internal means.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT02214381 -
A Prospective, Multicenter, Open-label 12 Week Neoadjuvant Phase II Trial Optimizing Taxane Therapy in Elderly Patients With Low Response
|
Phase 3 |