A 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
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About the trial
Detection of molecular relapse with circulating tumour DNA analysis can identify which patients with ER positive breast cancer are relapsing on adjuvant endocrine therapy. This trial will aim to demonstrate that palbociclib and fulvestrant, can defer or prevent relapse in patients with ctDNA detected molecular relapse. The TRAK-ER trial will have two phases, a ctDNA surveillance phase and a randomised therapy trial in patients with positive ctDNA. The TRAK-ER trial will establish a ctDNA screening programme for patients with ER positive breast cancer receiving adjuvant endocrine therapy with at least a further three years of standard adjuvant endocrine therapy planned. Patients recruited into the TRAK-ER study will have high-risk clinical features to identify patients at higher risk of future relapse. ctDNA assays will be used to identify which people are at very high risk of relapse (i.e. those with a positive ctDNA result), and randomise this high risk population between standard endocrine therapy versus palbociclib plus fulvestrant for up to two years.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Napisana zgoda na uczestnictwo w badaniu i oddanie próbek tkanki i krwi
- •Wiek 18 lat lub więcej
- •Dobry stan ogólny pacjenta (skala ECOG 0-2)
- •Rak piersi potwierdzony badaniem mikroskopowym: dodatni na receptor estrogenowy (ER+) i ujemny na receptor HER2
- •Rak piersi wysokiego ryzyka: albo powiększone węzły chłonne przy diagnozie, albo duży guz (>5 cm), albo kombinacja średniego guza ze złymi czynnikami prognostycznymi
- •Dostępna próbka tkanki z oryginalnego nowotworu
- •Brak przerzutów odległych potwierdzonych obrazowaniem
- •Otrzymywanie leczenia hormonalnego przez minimum 6 miesięcy do maksymalnie 7 lat z planem kontynuacji przez kolejne 3 lata
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- December 5, 2024
- Sex
- No restrictions
Therapies / drugs in trial
Locations (49)
Institut de Cancérologie de l'Ouest
Angers, France
Centre Hospitalier Annecy Genevois_Site d'Annecy
Annecy, France
Institut du Cancer Avignon Sainte Catherine
Avignon, France
Centre Hospitalier Simone Veil de Blois
Blois, France
Institut Bergonié
Bordeaux, France
Centre Jean Perrin
Clermont-Ferrand, France
Centre George François Leclerc
Dijon, France
Groupe Hospitalier Mutualiste de Grenoble
Grenoble, France
Clinique Chénieux
Limoges, France
Centre Hospitalier Universitaire de Limoges
Limoges, France
Centre Léon Bérard
Lyon, France
Institut Paoli Calmettes
Marseille, France
Institut de Cancérologie de l'Ouest
Nantes, France
Centre Antoine Lacassagne
Nice, France
Gustave Roussy Cancer Campus
Paris, France
Hôpital Américain de Paris
Paris, France
Institut Godinot
Reims, France
Centre Eugène Marquis
Rennes, France
Centre Henri Becquerel
Rouen, France
CHU de Saint Etienne-Institut de Cancérologie
Saint-Priest-en-Jarez, France
Institut Claudius Regaud
Toulouse, France
Barnet Hospital
London, United Kingdom
Royal Cornwall Hospitals NHS Trust
Truro, United Kingdom
University Hospitals Dorset: Royal Bournemouth Hospital
Bournemouth, United Kingdom
Royal Sussex Hospital
Brighton, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, United Kingdom
Velindre Cancer Centre
Cardiff, United Kingdom
Velindre University NHS Trust
Cardiff, United Kingdom
Darlington Memorial Hospital
Darlington, United Kingdom
Western General
Edinburgh, United Kingdom
Royal Devon and Exeter Hospital
Exeter, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
North West Anglia NHS Foundation Trust: Hinchingbrooke Hospital
Huntingdon, United Kingdom
St James's University Hospital
Leeds, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, United Kingdom
Barts Health NHS Trust
London, United Kingdom
Mount Vernon Hospital
London, United Kingdom
University College London Hospital
London, United Kingdom
The Royal Free Hospital
London, United Kingdom
The Royal Marsden NHS Foundation Trust
London, United Kingdom
Maidstone Hospital
Maidstone, United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom
Nottingham University Hopsitals NHS Trust
Nottingham, United Kingdom
Oxford Cancer & Haematology Centre, Churchill Hospital,
Oxford, United Kingdom
North West Anglia NHS Foundation Trust: Peterborough Hospital
Peterborough, United Kingdom
Derriford Hospital - UHPNT
Plymouth, United Kingdom
University Hospitals Dorset: Poole Hospital
Poole, United Kingdom
Weston Park Hospital
Sheffield, United Kingdom
Somerset NHS Foundation Trust
Taunton, United Kingdom
Trial contact
Project Manager
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.