APPALACHES (EORTC 1745-ETF-BCG)
Research type
Research Study
Full title
A Phase II study of Adjuvant PALbociclib as an Alternative to CHemotherapy in Elderly patientS with high-risk ER+/HER2- early breast cance (APPALACHES)
IRAS ID
257493
Contact name
Peter Schmid
Contact email
Sponsor organisation
European Organisation for research and treatment of Cancer
Eudract number
2018-002553-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
This study is for men and women aged 70 or over who have high-risk, ER+/HER2- early breast cancer, and are suitable for treatment with chemotherapy.
The purpose of the study is to find out whether giving the drug palbociclib together with anti-hormonal therapy works as least as well as the standard chemotherapy following by anti-hormonal therapy to stop the cancer coming back (recurring/relapsing) and with fewer side effects.
Breast cancer is the most common cancer in women and the second most common cause of cancer-related death in women worldwide. Cancer in older people is a major public health issue since the incidence of cancer increases with age, and the life expectancy of the Western population is increasing.
Although endocrine therapy is an effective therapy, some patients may relapse with metastatic disease, most likely due to the development of resistance to the therapy. Chemotherapy can be effective but toxic. This is why combined approaches of adjuvant endocrine therapy with other molecules such as CDK4/6 inhibitors are worth investigating.
The study has a translational research component where blood samples will also be analysed to understand the biomarkers for biological age.
This study will take place in NHS sites in the UK as part of a wider international study. The study is sponsored and coordinated by the EORTC (European Organisation for Research and Treatment of Cancer), a non-profit organisation based in Brussels.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
19/SC/0130
Date of REC Opinion
28 Jun 2019
REC opinion
Further Information Favourable Opinion