PALbociclib CoLlaborative Adjuvant Study
Research type
Research Study
Full title
A randomized phase III trial of Palbociclib with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone for hormone receptor positive (HR+) / human epidermal growth factor receptor 2 (HER2)-negative early breast cancer
IRAS ID
200813
Contact name
Alistair Ring
Contact email
Sponsor organisation
ABCSG GmbH
Eudract number
2014-005181-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
12 years, 2 months, 28 days
Research summary
Although many patients with hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) early breast cancer may be cured of their disease with optimal local and systemic therapy, a significant number of patients with stage II and III disease will experience disease recurrence. Adjuvant endocrine therapy for breast cancer can be extremely effective, particularly with extension beyond 5 years. However disease recurrence can occur, with risk distributed over the decades following initial diagnosis. Methods to improve the effectiveness of endocrine therapy, and delay the onset of resistance, are therefore needed.
HR+ breast cancer biologically may demonstrate features suggestive of sensitivity to CDK4/6 inhibition with drugs such as palbociclib. Given the demonstrated activity and safety of palbociclib in the first-line treatment of metastatic HR+/ HER2- breast cancer, supporting FDA approval, there is interest in whether the benefits of CDK4/6 inhibition may translate into the adjuvant setting. The PALLAS study has been designed to investigate this question, as to whether palbociclib given in addition to endocrine therapy can reduce the risks of recurrence in women with early stage (II and III) breast cancer. Whilst palbociclib has FDA approval for use in the metastatic setting, and is used in this population in clinical trials and a compassionate use programme in the UK, this drug is experimental in this setting of early stage (II and III) breast cancer.
PALLAS is a randomised, controlled, two-arm study, where participants will be treated with oral palbociclib and/or standard adjuvant endocrine therapy. About 4600 participants aged 18 years and over will be in the study across multiple countries. The purpose of the PALLAS study is to determine the effect of palbociclib + standard adjuvant endocrine therapy vs standard adjuvant endocrine therapy on invasive disease-free survival in patients with HR+/HER2- early breast cancer.
REC name
London - Central Research Ethics Committee
REC reference
16/LO/1069
Date of REC Opinion
5 Sep 2016
REC opinion
Further Information Favourable Opinion