CiPHER
Research type
Research Study
Full title
Phase II multicentre study assessing the efficacy of Cabazitaxel in Patients with HER2-negative metastatic breast cancer and having unresectable brain metastases.
IRAS ID
104669
Contact name
Zafar Malik
Contact email
Sponsor organisation
Research & Innovation
Eudract number
2012-000542-35
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
The prognosis for patients with breast cancer and with brain metastases is poor and clinically this represents a patient group with an unmet need. Whilst surgical excision or stereotactic radio surgery is an option for some patients, this is unfortunately not the case for the majority. These patients either receive palliative external beam radiotherapy or best supportive care and occassionally palliative chemotherapy according to physician's choice.
From in vitro work we know that Cabazitaxel crosses the blood brain barrier and it has also been shown to be effective in metastatic breast cancer in patients who have progressed after anthracycline and taxane treatment. Cabazitaxel is an effective cytotoxic agent that crosses the blood brain barrier and we hope to investigate this attribute in this Phase II study across several UK recruitment centres. Potentially this therapy could afford survival advantage.
Patients on this study will receive Cabazitaxel chemotherapy treatment or treatment of physician's choice with palliative radiotherapy administered wither before chemotherapy or upon evidence of CNS progression. These patients will be monitored clinically and radiologically every three and six weeks respectively.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
13/NW/0153
Date of REC Opinion
22 May 2013
REC opinion
Further Information Favourable Opinion