AzTrials
AzTrials

ER+ Breast CancerPhase 2TRAK-ERNCT04985266

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

A Phase 2 study testing Palbociclib 125Mg Tab, Fulvestrant injection and Tamoxifen in people with ER+ Breast Cancer and HER2-negative Breast Cancer, run by Royal Marsden NHS Foundation Trust at 49 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Palbociclib 125Mg Tab, Fulvestrant injection and Tamoxifen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,100 participants
Where
49 sitesin 2 countries
Study dates
30 Mar 2022to 1 Sep 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent to participate in the trial and to donation of tissue and blood samples
  • Male or female patients aged 18 years or older
  • ECOG performance status 0, 1 or 2 (see https://ecog-acrin.org/resources/ecog-performance-status)
  • Histologically proven primary ER+ (Allred score 6/8 or greater, or stain in ≥10% of cancer cells) and HER2- (immunohistochemistry 0/1+ and/or negative by in situ hybridization) breast cancer as determined by local laboratory
  • Patients with high risk early stage breast cancer according to at least one of the following criteria:
  • Primary surgery (no other treatment prior to surgery) A. Four or more involved axillary lymph nodes or positive supraclavicular lymph node at diagnosis, or
Show all 38Show fewer
  • Tumour size > 5 cm, regardless of lymph node status, or
  • 1-3 involved axillary lymph nodes and at least one of the following; i) Tumour size > 3 cm, ii) histological grade 3 iii) high genomic risk defined as Oncotype Dx Recurrence Score >=26, Prosigna score >=60, EPclin risk score >=4.0, or Mammaprint high risk category, or
  • Neoadjuvant chemotherapy (chemotherapy prior to surgery)
  • At least one lymph node positive (micrometastasis or macrometastasis) after chemotherapy
  • Lymph node negative and tumour size > 3 cm after chemotherapy
  • Neoadjuvant endocrine therapy (endocrine based therapy prior to surgery) Use the primary surgery criteria - staging tumour size and lymph node status may be either the pathological staging after endocrine therapy or on the initial clinical staging prior to neoadjuvant therapy
  • Available tissue from one archival tumour tissue sample (either from diagnostic biopsy, primary surgery or where available residual disease post-neoadjuvant chemotherapy)
  • No evidence of macroscopic distant metastatic disease or incurable locally advanced disease on staging scans conducted at any time since initial diagnosis.
  • Patients receiving standard endocrine therapy with aromatase inhibitors (letrozole, anastrazole, exemestane), tamoxifen, or combination of such for a minimum of 6 months* and maximum of 7 years duration with an additional three years of endocrine therapy planned. Pre- or peri-menopausal patients may also receive GnRH analogues.
  • patients may enrol during the first 6 months of standard endocrine therapy, and wait until at least 6 months of endocrine therapy has been received prior to starting ctDNA surveillance
  • Patients must have had surgery achieving clear margins (as per local guidelines)
  • Female and male patients of reproductive potential must be willing to use an adequate method of contraception for the first three years of the trial, if randomised to standard endocrine therapy for the duration of trial treatment through to at least 4 weeks after the last dose of trial treatment, and if randomised to fulvestrant and palbociclib to 2 years after the last dose of fulvestrant (see section 4.6). Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient.
  • Patients willing to have frequent blood tests.
  • Signed informed consent for treatment
  • ECOG performance status 0, 1 or 2
  • Women of childbearing potential should have a negative serum pregnancy test prior to randomisation. If randomisation occurs more than 72 hours prior to receiving the first dose of treatment the test must be repeated before treatment.
  • Female and male patients of childbearing potential must be willing to use an adequate method of contraception (section 4.6), starting with the first dose of treatment through 4 weeks after the last dose of treatment if randomised to standard endocrine therapy and 2 years after the last dose of fulvestrant if randomised to fulvestrant and palbociclib. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient. Female patients will be deemed not of childbearing potential if they are postmenopausal or have had irreversible sterilisation
  • Patient has adequate bone marrow and organ function as defined by the following laboratory values:
  • Absolute Neutrophil Count (ANC) ≥ 1.5 × 109/L
  • Platelets ≥ 100 × 109/L
  • Haemoglobin ≥ 100 g/L
  • INR ≤1.5
  • Creatinine <1.5 x ULN and creatinine clearance ≥30ml/min
  • Total bilirubin < ULN except for patients with Gilbert's syndrome who may only be included if the total bilirubin is ≤ 3.0 × ULN or direct bilirubin ≤ 1.5 × ULN.
  • Alanine aminotransferase (ALT) < 2.5 x ULN
  • Aspartate aminotransferase (AST) < 2.5 × ULN
  • Patients must be post-menopausal OR
  • Pre- or peri-menopausal patients or men may be enrolled if they have ovarian/gonadal suppression with licensed GnRH analogues. Patients must have commenced licensed GnRH analogues at least 2 weeks prior to Cycle 1 Day 1 and continue throughout the study if randomised to fulvestrant and palbociclib.
  • Post-menopausal female patients, as defined by at least one of the following:
  • Age ≥60 years;
  • Age <60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause, and serum estradiol and FSH levels within the institutional laboratory's reference range for post-menopausal females;
  • Documented bilateral oophorectomy;

Who cannot join

  • Any concurrent or planned treatment for the current diagnosis of breast cancer other than adjuvant endocrine therapy or a bisphosphonate.
  • Patients with prior exposure to a CDK 4/6 inhibitor as part of standard of care may enrol only after at least 12 months from completing CDK4/6 therapy.
  • Prior exposure to therapeutic dose of fulvestrant is not permitted. One subtherapeutic dose of fulvestrant is permitted.
  • Prior diagnosis of cancer including prior diagnosis of breast cancer in the previous 5 years, other than for non-melanoma carcinoma of the skin or cervical carcinoma in situ
  • Patients previously entered into a therapeutic trial where experimental therapy is continued post-surgery. Patients who have entered a clinical trial of a CDK4/6 inhibitor in the adjuvant setting are not eligible. Patients who received a CDK4/6 inhibitor only before an operation, with no post-operative adjuvant use, are eligible.
  • Treatment with an unlicensed or investigational product within 4 weeks prior registration to trial
Show all 44Show fewer
  • Patient has not recovered to ≤ grade 1 (except alopecia or certain other toxicities, which in the opinion of the Investigator should not exclude the patient) from related side effects of any prior antineoplastic therapy, not including side-effects of endocrine therapy
  • Patient with impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral medication (e.g. Crohn's disease, ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, or small bowel resection)
  • Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator' opinion cause unacceptable safety risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol.
  • Clinically significant uncontrolled heart disease including any of the following:
  • History of myocardial infarction (MI), angina pectoris, symptomatic pericarditis, or coronary artery bypass graft (CABG) within 6 months prior to trial entry
  • Symptomatic congestive heart failure
  • Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome.
  • Cardiac arrhythmia.
  • History of pneumonitis, interstitial lung disease or pulmonary fibrosis
  • Known history of Human Immunodeficiency Virus (HIV) (testing not required as part of study screening)
  • Known active Hepatitis B or Hepatitis C (testing not required as part of study screening)
  • Females who are known to be pregnant or breastfeeding
  • History of bleeding diathesis (i.e. disseminated intravascular coagulation, clotting factor deficiency), other known abnormalities in coagulation or treatment with anticoagulants. Low molecular weight heparin (LMWH), low dose aspirin or clopidogrel are permitted.
  • Child-Pugh class C hepatic impairment or creatinine clearance < 30ml/min.
  • Patient with bilateral tumours, or unilateral multifocal cancers with multiple separate primary cancers.(Multifocal cancer that reflects a single primary cancer, in the opinion of the investigator, are eligible)
  • Evidence of recurrent disease (metastatic or local, see section 6.6 for management of patients with potentially curable local recurrences) on staging scans conducted since positive ctDNA result
  • Known hypersensitivity to the excipients of palbociclib plus fulvestrant
  • Any anti-cancer treatment since enrolling in the TRAK-ER study other than hormonal therapy or a bisphosphonate. Prior exposure to fulvestrant is not permitted.
  • Diagnosis of an alternative cancer since enrolment in the trial other than non-melanoma cancer of the skin or cervical carcinoma in situ
  • Patient has had major surgery within 4 weeks prior to starting trial treatment or has not recovered from major side effects of such procedure
  • Patient is currently receiving warfarin or other coumarin derived anti-coagulant, for treatment, prophylaxis or otherwise. Therapy with unfractionated heparin, low molecular weight heparin (LMWH), or a direct-acting oral anticoagulant (DOAC such as rivaroxaban or fondaparinux) is allowed
  • Patient has not recovered to ≤ grade 1 (except alopecia or certain other toxicities, which in the opinion of the Investigator should not exclude the patient) from related side effects of any prior antineoplastic therapy, not including side-effects of endocrine therapy
  • Patient with impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral medication (e.g. Crohn's disease, ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, or small bowel resection)
  • Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator' opinion cause unacceptable safety risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol.
  • Clinically significant uncontrolled heart disease including any of the following:
  • History of myocardial infarction (MI), angina pectoris, symptomatic pericarditis, or coronary artery bypass graft (CABG) within 6 months prior to trial entry
  • Symptomatic congestive heart failure
  • Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome.
  • Cardiac arrhythmia.
  • Patient is currently receiving any of the following substances and cannot be discontinued 7 days prior to Cycle 1 Day 1:
  • Medications that are strong inducers or inhibitors of CYP3A4 (section 8.5.2)
  • Herbal preparations/medications, dietary supplements, fruits (e.g grapefruit, pomelos, starfruit, Seville oranges) and their juice
  • History of pneumonitis, interstitial lung disease or pulmonary fibrosis
  • Known history of HIV (testing not required as part of study screening)
  • Known active Hepatitis B or Hepatitis C (testing not required as part of study screening)
  • Patient has a history of non-compliance to medical regimen
  • History of bleeding diathesis (i.e. disseminated intravascular coagulation, clotting factor deficiency), other known abnormalities in coagulation or treatment with anticoagulants. Low molecular weight heparin (LMWH), low dose aspirin or clopidogrel are permitted.
  • Females who are known to be pregnant or breastfeeding.

Trial locations and contacts

49 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Project Manager contact

020 7808 2887

trak-er@rmh.nhs.uk

49 sites in 2 countries

United Kingdom28 sites, 28 recruiting

  • University Hospitals Dorset: Royal Bournemouth Hospital

    Bournemouth, BH7 7DW

    PI: Dr Amit Chakrabarti, amit.chakrabarti@uhd.nhs.uk

    Recruiting

  • Royal Sussex Hospital

    Brighton, BN2 5BE

    PI: Prof Gianfilippo Bertelli, 01273696955, g.bertelli@nhs.net

    Not yet recruiting

  • Bristol Haematology and Oncology Centre

    Bristol, BS2 8ED

    PI: Jeremy Braybrooke, 01173426295, Jeremy.Braybrooke@UHBW.nhs.uk

    Recruiting

  • Velindre Cancer Centre

    Cardiff, CF14 2TL

    PI: Dr Simon Waters, 02920615888, Simon.waters@wales.nhs.uk

    Recruiting

  • Velindre University NHS Trust

    Cardiff, CF14 2TL

    PI: Dr Simon Waters, 02920 615888, Simon.waters@wales.nhs.uk

    Recruiting

  • Darlington Memorial Hospital

    Darlington

    TBC

    Not yet recruiting

  • Western General

    Edinburgh, EH4 2XU

    PI: Dr Olga Oikonomidou, 01315372193, olga.oikonomidou@nhs.scot

    Recruiting

  • Royal Devon and Exeter Hospital

    Exeter, EX2 5DW

    PI: Dr Peter Stephens, 01392402118, peter.stephens4@nhs.net

    Recruiting

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

    PI: Prof Iain Macpherson, 01413017128, Iain.macpherson@ggc.scot.nhs.net

    Not yet recruiting

  • North West Anglia NHS Foundation Trust: Hinchingbrooke Hospital

    Huntingdon, PE29 6NT

    PI: Dr Indrani Bhattacharya, 01480416428, indrani.bhattacharya@nhs.net

    Recruiting

  • St James's University Hospital

    Leeds, LS9 7FT

    PI: Dr David Jackson, davidpjackson@nhs.net

    Not yet recruiting

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Liverpool

    PI: Professor Carlo Palmieri, 0151 556 5277, cpalmi@liverpool.ac.uk

    Recruiting

  • Barnet Hospital

    London, Barnet, EN5 3DJ

    PI: Neha Dr Chopra, 02073528171, neha.chopra@nhs.net

    Not yet recruiting

  • Barts Health NHS Trust

    London, EC1A 7BE

    PI: Dr Peter Hall, 0787 655 4899, peter.hall12@nhs.net

    Recruiting

  • Mount Vernon Hospital

    London, HA6 2RN

    PI: Dr Andreas Makris, 0333 332 5470, amakris@nhs.net

    Recruiting

  • University College London Hospital

    London, NW1 2BU

    PI: Dr Rebecca Roylance, r.roylance@ucl.ac.uk

    Recruiting

  • The Royal Free Hospital

    London, NW3 2QG

    PI: Dr Amna Sheri, 02077940500 ext. 31918, amna.sheri@nhs.net

    Recruiting

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ

    Project Manager, 02078082887, trak-er@rmh.nhs.uk

    Nicholas Turner

    Recruiting

  • Maidstone Hospital

    Maidstone, ME16 9QQ

    PI: Dr Catherine Harper-Wynne, 01622228631, charperwynne@nhs.net

    Not yet recruiting

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

    PI: Dr Ciara O'Brien, Ciara.obrien3@nhs.net

    Recruiting

  • Nottingham University Hopsitals NHS Trust

    Nottingham, NG5 1PB

    Sarah Khan, PI, 01159691169, sarah.khan@nuh.nhs.uk

    Recruiting

  • Oxford Cancer & Haematology Centre, Churchill Hospital,

    Oxford, OX3 7LE

    PI: Dr Mark Tuthill, 01865 72033, mark.tuthill@ouh.nhs.uk

    Recruiting

  • North West Anglia NHS Foundation Trust: Peterborough Hospital

    Peterborough, PE3 9GZ

    PI: Sarah Ayers, s.ayers@nhs.net

    Recruiting

  • Derriford Hospital - UHPNT

    Plymouth, PL6 8DH

    PI: Dr Sidharth Dubey, 01752 431957, sdubey@nhs.net

    Recruiting

  • University Hospitals Dorset: Poole Hospital

    Poole, BH15 2JB

    PI: Dr Amit Chakrabarti, amit.chakrabarti@uhd.nhs.uk

    Recruiting

  • Weston Park Hospital

    Sheffield, S10 2SJ

    Matthew Winter, 01142265079, matthewwinter@nhs.net

    Recruiting

  • Somerset NHS Foundation Trust

    Taunton, TA1 5DA

    PI: Dr Saiqa Spensley, 01823 342417, Saiqa.Spensley@SomersetFT.nhs.uk

    Recruiting

  • Royal Cornwall Hospitals NHS Trust

    Truro, Cornwall, TR1 3LJ

    PI: Alistair Thomson, 01872258303, alistairthomson1@nhs.net

    Recruiting

Other trials in United Kingdom

France21 sites, 20 recruiting

  • Institut de Cancérologie de l'Ouest

    Angers, 49055

    Anne Patsouris, 0241352700, anne.patsouris@ico.unicancer.fr

    Recruiting

  • Centre Hospitalier Annecy Genevois_Site d'Annecy

    Annecy, 90074

    PI, Dr Marie Vallee, 0450635444, mvallee@ch-annecycygenevois.fr

    Recruiting

  • Institut du Cancer Avignon Sainte Catherine

    Avignon, 84000

    Dr Julien Grenier, +33490276397, j.grenier@isc84.org

    Recruiting

  • Centre Hospitalier Simone Veil de Blois

    Blois, 41016

    Oliver Arsene, +33(0)254556405, arseneo@ch-blois.fr

    Recruiting

  • Institut Bergonié

    Bordeaux

    Monica Arnedos, m.arnedos@bordeaux.bergonie.fr

    Recruiting

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

    PI: Dr Xavier Durando, +334773278005, xavier.durando@clermont.unicancer.fr

    Recruiting

  • Centre George François Leclerc

    Dijon, 21079

    Sylvain Ladoire, +33380737775, sladoire@cgfl.fr

    Recruiting

  • Groupe Hospitalier Mutualiste de Grenoble

    Grenoble, 38000

    Elise Bonnet, +33(0)476285232, elise.bonnet@avec.fr

    Recruiting

  • Clinique Chénieux

    Limoges, 87000

    Dominque Genet, +33(0)555454800, dg@imagemed-87.com

    Recruiting

  • Centre Hospitalier Universitaire de Limoges

    Limoges, 87042

    Elise Deluche, elise.deluche@chu-limoges.fr

    Recruiting

  • Centre Léon Bérard

    Lyon, 69373

    Dr Thomas Bachelot, +33478782654, thomas.bachelot@lyon.unicancer.fr

    Recruiting

  • Institut Paoli Calmettes

    Marseille, 13273

    Dr Renaud Sabatier, +33491223789, sabatierr@ipc.unicancer.fr

    Recruiting

  • Institut de Cancérologie de l'Ouest

    Nantes, 44805

    PI: Dr Marie Robert, marie.robert@ico.unicancer.fr

    Recruiting

  • Centre Antoine Lacassagne

    Nice, 06189

    PI: Dr Caroline Bailleux, +33492031114, Caroline.bailleux@nice.unicancer.fr

    Recruiting

  • Gustave Roussy Cancer Campus

    Paris, 94800

    Fabrice Andre, 01.42.11.42.93, fabrice.andre@gustaveroussy.fr

    Recruiting

  • Hôpital Américain de Paris

    Paris

    Withdrawn

  • Institut Godinot

    Reims, 51726

    Dr Christelle Jouannaud, +33326504383, christelle.jouannaud@reims.unicancer.fr

    Recruiting

  • Centre Eugène Marquis

    Rennes, 25042

    Dr Fanny Le Du, +33299252956, f.ledu@rennes.unicancer.fr

    Recruiting

  • Centre Henri Becquerel

    Rouen, 76038

    Marianne Leheurteur, marianne.leheurteur@chb.unicancer.fr

    Recruiting

  • CHU de Saint Etienne-Institut de Cancérologie

    Saint-Priest-en-Jarez, 42270

    Gilles Freyer, +33(0)477822937

    Recruiting

  • Institut Claudius Regaud

    Toulouse, 31059

    Dr Florence Dolenc, +33531155122, dalenc.florence@juct-oncopole.fr

    Recruiting

Other trials in France

About this study

Official 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

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.

Read more

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.

Read the detailed description

The TRAK-ER trial is a multi-centre, randomised, open-label trial in patients with early stage oestrogen reception positive (ER+) human epidermal growth receptor-2 negative (HER2-) breast cancer, whom have detectable circulating DNA (ctDNA) but no overt macroscopic disease on imaging. TRAK-ER aims to demonstrate that fulvestrant plus palbociclib improves relapse free survival compared to standard endocrine therapy in this patient group.

Despite current treatment, patients with ER+HER2- breast cancer are considered high-risk of distant recurrence for more than the first two decades after initial diagnosis. ctDNA analysis provides a non-invasive, serial source of tumour material which can monitor tumour dynamics and detect molecular relapse.

TRAK-ER will be split into two phases, the first surveillance phase aims to investigate the use of ctDNA to identify and predict the risk of molecular relapse in early ER+/HER2- breast cancer patients whom are receiving adjuvant endocrine therapy with no overt macroscopic disease on imaging. Using ctDNA assays, patients enrolled on TRAK-ER will receive ctDNA testing on a three-monthly basis for up to three years. In the instance where ctDNA is detected, imaging will determine whether overt disease is present. If a patient had a positive ctDNA detection and no macroscopic disease on the staging scan, the patient will be randomised to one of the treatment groups in the second phase of TRAK-ER, the treatment phase.

The treatment phase of TRAK-ER will be a randomised, open-label study which aims to determine whether fulvestrant plus palbociclib (intervention arm) improves relapse free survival compared to standard endocrine therapy (control arm) in patients carried through from the surveillance phase. Patients on each arm will receive treatment (fulvestrant plus palbociclib or standard endocrine therapy) for up to 24 months. Six monthly imaging will determine the presence of macroscopic disease. If macroscopic disease is observed, the patient will discontinue TRAK-ER treatment and commence standard therapy outside of the TRAK-ER trial.

Being tested
Palbociclib 125Mg Tab, Fulvestrant injection, Tamoxifen, Letrozole, Exemestane

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Palbociclib 125Mg TabDrug

    Palbociclib Tablets, 125 mg orally once daily, beginning on Cycle 1, on Days 1-21 of each 28-day cycle.

  • Fulvestrant injectionDrug

    Fulvestrant Intramuscular injections, 500 mg as two injection of 250mg fulvestrant in 5ml solution at each visit. No fulvestrant dose reductions are permitted. Administered on days 1, 15 (plus or minus 3 days), 29 (plus or minus 3 days), and every 28 (plus or minus 3 days) days thereafter.

  • TamoxifenDrug

    As per clinical guidelines

  • LetrozoleDrug

    As per clinical guidelines

  • ExemestaneDrug

    As per clinical guidelines

  • AnastrozoleDrug

    As per clinical guidelines

Study groups in NCT04985266
Study groupRoleWhat they receive
Standard endocrine therapyActive comparatorStandard endocrine therapy will continue for up to 24 months on trial. Standard endocrine therapies include tamoxifen, and aromatase inhibitors (letrozole, anastrazole, exemestane).
Receives: Drug: Tamoxifen; Drug: Letrozole; Drug: Exemestane; Drug: Anastrozole
Palbociclib and fulvestrantExperimentalTreatment with palbociclib plus fulvestrant will continue for a maximum of 24 months. Palbociclib will be given orally once a day on days 1-21 of each 28 day cycle. Fulvestrant 500 mg will be administered on cycle 1 days 1 and 15, cycle 2 day 1 and then every 28 days thereafter (plus or minus 3 days) as two intramuscular injections of 250mg fulvestrant at each visit.
Receives: Drug: Palbociclib 125Mg Tab; Drug: Fulvestrant injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of positive ctDNA result during surveillance (Surveillance phase)

    Test during the surveillance phase detects presence of ctDNA

    Measured: Up to 36 months from entry to study

  2. Incidence of positive ctDNA result at first test (Surveillance phase)

    Test during the surveillance phase detects presence of ctDNA in the first test

    Measured: Start of study

  3. Relapse free survival (Treatment phase)

    Time from randomization to invasive local/regional recurrence (including ipsilateral invasive breast recurrence) or distant recurrence or death from any cause. Patients with second primary invasive cancers (breast or non-breast) would be censored at time of detection.

    Measured: 60 months from randomisation

Secondary outcomes (10)

  1. Frequency and Severity of adverse events

    Frequency and severity of Adverse Events (AEs) assessed as per CTCAE v5

    Measured: up to 24 months from randomisation

  2. Overall survival

    Time from randomisation to death from any cause

    Measured: up to 60 months from randomisation

  3. Invasive disease free survival

    Time from randomisation to invasive local/regional recurrence (including ipsilateral invasive breast recurrence), new breast cancer (ipsilateral or contralateral) or distant recurrence or death from any cause. Patients with non-invasive recurrences or second primary invasive cancers (non-breast) would be censored at time of detection.

    Measured: up to 60 months from randomisation

  4. Distant recurrence free survival

    Time from randomization to distant invasive breast cancer recurrence or death from any cause. Patients with new contralateral invasive breast cancers or second primary invasive non-breast cancers would be censored at time of detection.

    Measured: up to 60 months from randomisation

  5. EQ-5D-5L quality of life assessment: Mobility element

    Assessed using the 5-point scale.

    Measured: up to 24 months from randomisation

  6. EQ-5D-5L quality of life assessment: Self-care element

    Assessed using the 5-point scale.

    Measured: up to 24 months from randomisation

  7. EQ-5D-5L quality of life assessment: Usual activities element

    Assessed using the 5-point scale.

    Measured: up to 24 months from randomisation

  8. EQ-5D-5L quality of life assessment: Pain/ Discomfort element

    Assessed using the 5-point scale.

    Measured: up to 24 months from randomisation

  9. EQ-5D-5L quality of life assessment: Anxiety/ Depression element

    Assessed using the 5-point scale.

    Measured: up to 24 months from randomisation

  10. EQ-5D-5L quality of life assessment: Visual Analogue Scale

    Assessed using 0-100 scale.

    Measured: up to 24 months from randomisation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2021
  2. Study start30 Mar 2022
  3. Primary completion1 Sep 2027 (estimated)
  4. Study completion1 Sep 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04985266
Sponsor's protocol ID
CCR5316
Acronym
TRAK-ER
Status last verified
Dec 2024
First submitted
25 Jun 2021
Last updated
5 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Dawson SJ, Tsui DW, Murtaza M, Biggs H, Rueda OM, Chin SF, Dunning MJ, Gale D, Forshew T, Mahler-Araujo B, Rajan S, Humphray S, Becq J, Halsall D, Wallis M, Bentley D, Caldas C, Rosenfeld N. Analysis of circulating tumor DNA to monitor metastatic breast cancer. N Engl J Med. 2013 Mar 28;368(13):1199-209. doi: 10.1056/NEJMoa1213261. Epub 2013 Mar 13.

    PubMed 23484797

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Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Palbociclib 125Mg Tab, Fulvestrant injection and Tamoxifen in people with ER+ Breast Cancer and HER2-negative Breast Cancer, run by Royal Marsden NHS Foundation Trust at 49 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 38 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United Kingdom, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Project Manager (020 7808 2887, trak-er@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of positive ctDNA result during surveillance (Surveillance phase) (time frame: Up to 36 months from entry to study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04985266, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.

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