*TRAK-ER
Research type
Research Study
Full title
A randomised trial of early detection of molecular relapse with circulating tumour DNA tracking and treatment with palbociclib plus fulvestrant versus standard endocrine therapy in patients with ER positive HER2 negative breast cancer
IRAS ID
286505
Contact name
Nicholas Turner
Contact email
Sponsor organisation
The Royal Marsden NHS Foundation Trust
Eudract number
2020-004022-36
Clinicaltrials.gov Identifier
Duration of Study in the UK
9 years, 0 months, 1 days
Research summary
Treatments for breast cancer have been increasingly successful. However for patients who have recurrence of their cancer prognosis is still poor. This study will look at patients with treatable cancer that was estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-).
Patients who have completed any surgery, chemotherapy and radiotherapy and are taking long-term endocrine (hormone) therapy will be approached. Participants will undergo up to 3 years of circulating tumour DNA (ctDNA) testing. It has been demonstrated in previous research that this can detect presence of cancerous cells that would not be detected by other means. The first objective of the study is to see how many participants are found to be ctDNA positive.
Participants who test positive for ctDNA will be asked to participate in the therapeutic phase of the study. If they give consent they will be randomised to either palbociclib and fulvestrant or standard endocrine therapy. Those randomised to endocrine therapy will be given an option for their treatment to be changed from their previous therapy to an alternative endocrine therapy (see protocol). Palbociclib and fulvestrant is a standard treatment of patients with recurrent cancer, and this study will aim to investigate the introduction of this treatment early at the point of ctDNA detection. The objective is to demonstrate that early detection of recurrence through ctDNA and initiation of effective therapies can improve prognosis.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
22/WM/0188
Date of REC Opinion
27 Aug 2021
REC opinion
Further Information Favourable Opinion