PALLET
Research type
Research Study
Full title
A phase II randomised study evaluating the biological and clinical effects of the combination of palbociclib with letrozole as neoadjuvant therapy in post-menopausal women with ER+ primary breast cancer.
IRAS ID
148513
Contact name
Stephen Johnston
Contact email
Sponsor organisation
The Institute of Cancer Research/The Royal Marsden NHS Trust
Eudract number
2014-000887-16
Clinicaltrials.gov Identifier
CRUK/13/031, CRUK Reference Number
Research summary
PALLET will evaluate whether adding a new drug called palbociclib to standard hormone therapy with letrozole is better than using letrozole alone at treating breast cancer before surgery. Post-menopausal women, newly diagnosed with hormone sensitive (also known as oestrogen receptor positive) early breast cancer will be invited to join the PALLET trial.
Patients will be randomised to one of four treatment groups:
Group A: Letrozole alone
Group B: Letrozole for 2 weeks followed by letrozole + palbociclib to week 14
Group C: Palbociclib for 2 weeks followed by letrozole + palbociclib to week 14
Group D: Letrozole + palbociclib to week 14.After week 14, all patients should continue to receive letrozole (the standard therapy) until surgery.
Response to the study treatment will be assessed by ultrasound imaging, which will be performed at baseline and the end of treatment.
An important part of the PALLET trial is to look at blood and tumour samples that will be donated by patients at three timepoints during the trial; before treatment starts, after 2 weeks of treatment and at the end of trial treatment. The aim is to find out who will be helped the most by the combination treatment by looking at the way cancer reacts to the drugs.
The PALLET trial is a collaboration between UK investigators and the US NSABP group. Parallel protocols will be conducted in the UK and North America, with the aim of recruiting 306 women to take part in this study globally. The main analysis will include all patients randomised in the UK and North America.
REC name
London - Fulham Research Ethics Committee
REC reference
14/LO/1291
Date of REC Opinion
1 Sep 2014
REC opinion
Further Information Favourable Opinion