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.
Disease site: Breast cancer
Treatment modality: Systemic therapy
Status: In follow up
PALLET is an international, multicentre, phase II, randomised, open label collaborative study to assess the biological and clinical effects of palbociclib in women with ER+/HER2-, invasive early breast cancer, with or without letrozole, in the neoadjuvant setting.
PALLET will be run in parallel in the UK and in North America. The UK trial is managed by ICR-CTSU.
A total of 306 patients will be randomised to receive one of four treatments before their breast cancer surgery:
- Letrozole alone for 14 weeks
- Letrozole for 2 weeks followed by letrozole + palbociclib to 14 weeks
- Palbociclib for 2 weeks followed by letrozole + palbociclib to 14 weeks
- Letrozole + palbociclib for 14 weeks.
Patients will be followed up for 1 year following randomisation.
Chief Investigator: Professor Stephen Johnston, The Royal Marsden NHS Foundation Trust
ICR-CTSU Scientific Lead: Professor Judith Bliss
Biological Lead: Professor Mitch Dowsett
Trial management contact: [email protected]
Sponsor: The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust
Funding: PALLET is funded Pfizer and endorsed by Cancer Research UK.
Further information including recruitment progress is available from the following link:
Patient friendly information is available from the following link:
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