NEO21-RS Study
Research type
Research Study
Full title
NEO21-RS: A phase II randomised study of the cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with oestrogen suppression therapy versus oestrogen suppression therapy alone as neoadjuvant therapy in ER-positive intermediate recurrence score primary breast cancer
IRAS ID
236974
Contact name
Ediri O'Brien
Contact email
Sponsor organisation
The University of Liverpool
Eudract number
2018-000157-41
Duration of Study in the UK
3 years, 6 months, days
Research summary
The purpose of this study is to look at different breast cancer treatments given to shrink the tumour before having surgery to remove it. Treatment given before surgery is called neoadjuvant therapy and this can be either hormone therapy or chemotherapy.
A test called the Oncotype DX Breast Recurrence Score®, when used after breast surgery can help decide whether chemotherapy is needed to treat the tumour or if hormone therapy alone is the right treatment. Breast cancers with a low recurrence score (RS) are treated with hormone therapy, while for those with a high RS chemotherapy is recommended followed by hormone therapy. In breast cancers that have an intermediate RS it is not known what is the best treatment and if chemotherapy is needed to treat these cancers. Currently, the Oncotype DX® test is not available to patients who need treatment before surgery (neoadjuvant treatment). This study will give patients needing treatment before surgery access to this test. Patients with a low RS will receive hormone therapy, while those with a high RS will be treated with chemotherapy. If the breast cancer has an intermediate RS these will be randomised to compare hormone treatment alone against hormone treatment plus a new drug called Palbociclib. All patients entered will be followed up and how effective the treatment received at shrinking the breast cancer recorded.
There are 2 components to this study:
• An observational study of the outcomes for patients whose tumours have a low and high RS
• A randomised trial to compare two different treatments for patients whose tumours have an intermediate RS breast cancers. Half will receive hormone therapy on its own and the other half will have hormone therapy plus a new drug called palbociclib.REC name
North West - Haydock Research Ethics Committee
REC reference
18/NW/0110
Date of REC Opinion
26 Mar 2018
REC opinion
Favourable Opinion