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

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 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

• ER+ Breast Cancer
• HER2-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

Sponsors & Collaborators

• Pfizer

  collaborator INDUSTRY

• AstraZeneca

  collaborator INDUSTRY

• Institute of Cancer Research, United Kingdom

  collaborator OTHER

• UNICANCER

  collaborator OTHER

• Gustave Roussy, Cancer Campus, Grand Paris

  collaborator OTHER

• Invitae Corporation

  collaborator INDUSTRY

• Royal Marsden NHS Foundation Trust

  lead OTHER

Principal Investigators

• Nicholas Turner · Royal Marsden NHS Foundation Trust

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-30

Primary Completion

2027-09-01

Completion

2030-09-01

Countries

• France
• United Kingdom

Study Locations