Actively Recruiting
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
Led by Royal Marsden NHS Foundation Trust · Updated on 2024-12-05
1100
Participants Needed
49
Research Sites
439 weeks
Total Duration
On this page
Sponsors
R
Royal Marsden NHS Foundation Trust
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent for participation and sample donation
- Male or female aged 18 years or older
- ECOG performance status of 0, 1, or 2
- Histologically confirmed ER+ (Allred score ≥6/8 or ≥10% staining) and HER2- breast cancer
- High-risk early stage breast cancer defined by specific lymph node involvement, tumor size, grade, or genomic risk scores
- Available archival tumor tissue sample
- No visible distant metastatic or incurable locally advanced disease on imaging
- Receiving standard endocrine therapy (aromatase inhibitors or tamoxifen) for 6 months up to 7 years with at least three more years planned
- Surgery with clear margins completed
- Willingness to use contraception if of reproductive potential during study treatment and follow-up
- Willing to have frequent blood tests
- For treatment phase: signed consent, ECOG 0-2, negative pregnancy test if applicable, adequate bone marrow and organ function
- Post-menopausal or with ovarian/gonadal suppression if pre/peri-menopausal or male
You will not qualify if you...
- Receiving or planned treatments other than standard endocrine therapy or bisphosphonates for current breast cancer
- Prior CDK 4/6 inhibitor use within 12 months or therapeutic fulvestrant exposure
- Prior cancer diagnosis within 5 years except certain skin or cervical cancers
- Participation in other therapeutic trials with continued experimental therapy post-surgery
- Recent investigational product use within 4 weeks
- Unresolved side effects from prior cancer therapy above grade 1 (except certain exceptions)
- Significant gastrointestinal conditions affecting drug absorption
- Severe uncontrolled medical or heart conditions including recent heart attack, heart failure, arrhythmias, or long QT syndrome
- History of pneumonitis, interstitial lung disease, or pulmonary fibrosis
- Known HIV or active Hepatitis B or C infections
- Pregnant or breastfeeding females
- Bleeding disorders or anticoagulant treatments except low molecular weight heparin, low dose aspirin, or clopidogrel
- Severe liver impairment or low kidney function
- Bilateral or multifocal cancers except certain cases
- Known hypersensitivity to trial drugs
- Use of certain medications or supplements that interact with study drugs and cannot be stopped
- History of non-compliance to medical regimens
- Recent major surgery not fully recovered
- Current use of warfarin or coumarin anticoagulants
- Other conditions posing safety risks or compromising study compliance
AI-Screening
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Trial Site Locations
Total: 49 locations
1
Institut de Cancérologie de l'Ouest
Angers, France, 49055
Actively Recruiting
2
Centre Hospitalier Annecy Genevois_Site d'Annecy
Annecy, France, 90074
Actively Recruiting
3
Institut du Cancer Avignon Sainte Catherine
Avignon, France, 84000
Actively Recruiting
4
Centre Hospitalier Simone Veil de Blois
Blois, France, 41016
Actively Recruiting
5
Institut Bergonié
Bordeaux, France
Actively Recruiting
6
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Actively Recruiting
7
Centre George François Leclerc
Dijon, France, 21079
Actively Recruiting
8
Groupe Hospitalier Mutualiste de Grenoble
Grenoble, France, 38000
Actively Recruiting
9
Clinique Chénieux
Limoges, France, 87000
Actively Recruiting
10
Centre Hospitalier Universitaire de Limoges
Limoges, France, 87042
Actively Recruiting
11
Centre Léon Bérard
Lyon, France, 69373
Actively Recruiting
12
Institut Paoli Calmettes
Marseille, France, 13273
Actively Recruiting
13
Institut de Cancérologie de l'Ouest
Nantes, France, 44805
Actively Recruiting
14
Centre Antoine Lacassagne
Nice, France, 06189
Actively Recruiting
15
Gustave Roussy Cancer Campus
Paris, France, 94800
Actively Recruiting
16
Hôpital Américain de Paris
Paris, France
Withdrawn
17
Institut Godinot
Reims, France, 51726
Actively Recruiting
18
Centre Eugène Marquis
Rennes, France, 25042
Actively Recruiting
19
Centre Henri Becquerel
Rouen, France, 76038
Actively Recruiting
20
CHU de Saint Etienne-Institut de Cancérologie
Saint-Priest-en-Jarez, France, 42270
Actively Recruiting
21
Institut Claudius Regaud
Toulouse, France, 31059
Actively Recruiting
22
Barnet Hospital
London, Barnet, United Kingdom, EN5 3DJ
Not Yet Recruiting
23
Royal Cornwall Hospitals NHS Trust
Truro, Cornwall, United Kingdom, TR1 3LJ
Actively Recruiting
24
University Hospitals Dorset: Royal Bournemouth Hospital
Bournemouth, United Kingdom, BH7 7DW
Actively Recruiting
25
Royal Sussex Hospital
Brighton, United Kingdom, BN2 5BE
Not Yet Recruiting
26
Bristol Haematology and Oncology Centre
Bristol, United Kingdom, BS2 8ED
Actively Recruiting
27
Velindre Cancer Centre
Cardiff, United Kingdom, CF14 2TL
Actively Recruiting
28
Velindre University NHS Trust
Cardiff, United Kingdom, CF14 2TL
Actively Recruiting
29
Darlington Memorial Hospital
Darlington, United Kingdom
Not Yet Recruiting
30
Western General
Edinburgh, United Kingdom, EH4 2XU
Actively Recruiting
31
Royal Devon and Exeter Hospital
Exeter, United Kingdom, EX2 5DW
Actively Recruiting
32
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
Not Yet Recruiting
33
North West Anglia NHS Foundation Trust: Hinchingbrooke Hospital
Huntingdon, United Kingdom, PE29 6NT
Actively Recruiting
34
St James's University Hospital
Leeds, United Kingdom, LS9 7FT
Not Yet Recruiting
35
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, United Kingdom
Actively Recruiting
36
Barts Health NHS Trust
London, United Kingdom, EC1A 7BE
Actively Recruiting
37
Mount Vernon Hospital
London, United Kingdom, HA6 2RN
Actively Recruiting
38
University College London Hospital
London, United Kingdom, NW1 2BU
Actively Recruiting
39
The Royal Free Hospital
London, United Kingdom, NW3 2QG
Actively Recruiting
40
The Royal Marsden NHS Foundation Trust
London, United Kingdom, SW3 6JJ
Actively Recruiting
41
Maidstone Hospital
Maidstone, United Kingdom, ME16 9QQ
Not Yet Recruiting
42
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Actively Recruiting
43
Nottingham University Hopsitals NHS Trust
Nottingham, United Kingdom, NG5 1PB
Actively Recruiting
44
Oxford Cancer & Haematology Centre, Churchill Hospital,
Oxford, United Kingdom, OX3 7LE
Actively Recruiting
45
North West Anglia NHS Foundation Trust: Peterborough Hospital
Peterborough, United Kingdom, PE3 9GZ
Actively Recruiting
46
Derriford Hospital - UHPNT
Plymouth, United Kingdom, PL6 8DH
Actively Recruiting
47
University Hospitals Dorset: Poole Hospital
Poole, United Kingdom, BH15 2JB
Actively Recruiting
48
Weston Park Hospital
Sheffield, United Kingdom, S10 2SJ
Actively Recruiting
49
Somerset NHS Foundation Trust
Taunton, United Kingdom, TA1 5DA
Actively Recruiting
Research Team
P
Project Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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