BLUEBELL
Research type
Research Study
Full title
A proof of concept phase II study of Buparlisib in HER2 positive breast cancer with brain metastasis following HER2 directed monoclonal antibody therapy
IRAS ID
181686
Contact name
Carlo Palmieri
Contact email
Eudract number
2015-003103-27
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
The prognosis for patients with brain metastasis secondary to breast cancer is poor and clinically this represents a patient group with an unmet need. Central Nervous System (CNS) metastasis is a particular feature of HER2 positive breast cancer and remains a major clinical challenge.
This is an open-label, multicentre, single arm window-of-opportunity Phase II trial. The trial will evaluate the effects of 2-weeks preoperative therapy with buparlisib in women with previously confirmed HER2-positive breast cancer with newly diagnosed brain metastasis following HER2-directed antibody therapy and who are considered a candidate for brain resection surgery.
Treatment is planned for 14-17 days (depending on the date of the surgery) and the last dose will be given the day before surgery. The effects of the study treatment will be primarily assessed by a FLT-PET scan which will be performed before the buparlisib treatment is started and again after it is finished.
REC name
North West - Haydock Research Ethics Committee
REC reference
16/NW/0066
Date of REC Opinion
22 Feb 2016
REC opinion
Favourable Opinion