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

PHASE2RecruitingINTERVENTIONAL
Enrollment

1,100

Participants

Timeline

Start Date

March 30, 2022

Primary Completion Date

September 1, 2027

Study Completion Date

September 1, 2030

Conditions
ER+ Breast CancerHER2-negative Breast Cancer
Interventions
DRUG

Palbociclib 125Mg Tab

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

DRUG

Fulvestrant injection

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.

DRUG

Tamoxifen

As per clinical guidelines

DRUG

Letrozole

As per clinical guidelines

DRUG

Exemestane

As per clinical guidelines

DRUG

Anastrozole

As per clinical guidelines

Trial Locations (49)

13273

RECRUITING

Institut Paoli Calmettes, Marseille

21079

RECRUITING

Centre George François Leclerc, Dijon

25042

RECRUITING

Centre Eugène Marquis, Rennes

31059

RECRUITING

Institut Claudius Regaud, Toulouse

38000

RECRUITING

Groupe Hospitalier Mutualiste de Grenoble, Grenoble

41016

RECRUITING

Centre Hospitalier Simone Veil de Blois, Blois

42270

RECRUITING

CHU de Saint Etienne-Institut de Cancérologie, Saint-Priest-en-Jarez

44805

RECRUITING

Institut de Cancérologie de l'Ouest, Nantes

49055

RECRUITING

Institut de Cancérologie de l'Ouest, Angers

51726

RECRUITING

Institut Godinot, Reims

63011

RECRUITING

Centre Jean Perrin, Clermont-Ferrand

69373

RECRUITING

Centre Léon Bérard, Lyon

76038

RECRUITING

Centre Henri Becquerel, Rouen

84000

RECRUITING

Institut du Cancer Avignon Sainte Catherine, Avignon

87000

RECRUITING

Clinique Chénieux, Limoges

87042

RECRUITING

Centre Hospitalier Universitaire de Limoges, Limoges

90074

RECRUITING

Centre Hospitalier Annecy Genevois_Site d'Annecy, Annecy

94800

RECRUITING

Gustave Roussy Cancer Campus, Paris

Unknown

RECRUITING

Institut Bergonié, Bordeaux

WITHDRAWN

Hôpital Américain de Paris, Paris

NOT_YET_RECRUITING

Darlington Memorial Hospital, Darlington

RECRUITING

The Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool

06189

RECRUITING

Centre Antoine Lacassagne, Nice

EN5 3DJ

NOT_YET_RECRUITING

Barnet Hospital, London

TR1 3LJ

RECRUITING

Royal Cornwall Hospitals NHS Trust, Truro

BH7 7DW

RECRUITING

University Hospitals Dorset: Royal Bournemouth Hospital, Bournemouth

BN2 5BE

NOT_YET_RECRUITING

Royal Sussex Hospital, Brighton

BS2 8ED

RECRUITING

Bristol Haematology and Oncology Centre, Bristol

CF14 2TL

RECRUITING

Velindre Cancer Centre, Cardiff

RECRUITING

Velindre University NHS Trust, Cardiff

EH4 2XU

RECRUITING

Western General, Edinburgh

EX2 5DW

RECRUITING

Royal Devon and Exeter Hospital, Exeter

G12 0YN

NOT_YET_RECRUITING

Beatson West of Scotland Cancer Centre, Glasgow

PE29 6NT

RECRUITING

North West Anglia NHS Foundation Trust: Hinchingbrooke Hospital, Huntingdon

LS9 7FT

NOT_YET_RECRUITING

St James's University Hospital, Leeds

EC1A 7BE

RECRUITING

Barts Health NHS Trust, London

HA6 2RN

RECRUITING

Mount Vernon Hospital, London

NW1 2BU

RECRUITING

University College London Hospital, London

NW3 2QG

RECRUITING

The Royal Free Hospital, London

SW3 6JJ

RECRUITING

The Royal Marsden NHS Foundation Trust, London

ME16 9QQ

NOT_YET_RECRUITING

Maidstone Hospital, Maidstone

M20 4BX

RECRUITING

The Christie NHS Foundation Trust, Manchester

NG5 1PB

RECRUITING

Nottingham University Hopsitals NHS Trust, Nottingham

OX3 7LE

RECRUITING

Oxford Cancer & Haematology Centre, Churchill Hospital,, Oxford

PE3 9GZ

RECRUITING

North West Anglia NHS Foundation Trust: Peterborough Hospital, Peterborough

PL6 8DH

RECRUITING

Derriford Hospital - UHPNT, Plymouth

BH15 2JB

RECRUITING

University Hospitals Dorset: Poole Hospital, Poole

S10 2SJ

RECRUITING

Weston Park Hospital, Sheffield

TA1 5DA

RECRUITING

Somerset NHS Foundation Trust, Taunton

Sponsors
All Listed Sponsors
collaborator

Pfizer

INDUSTRY

collaborator

AstraZeneca

INDUSTRY

collaborator

Institute of Cancer Research, United Kingdom

OTHER

collaborator

UNICANCER

OTHER

collaborator

Gustave Roussy, Cancer Campus, Grand Paris

OTHER

collaborator

Invitae Corporation

INDUSTRY

lead

Royal Marsden NHS Foundation Trust

OTHER