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

Sponsor
Royal Marsden NHS Foundation Trust
Study ID
NCT04985266
Phase
PHASE2
Status
Recruiting
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Conditions

  • ER+ Breast Cancer
  • HER2-negative Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Palbociclib 125Mg Tab — DRUG
    Palbociclib Tablets, 125 mg orally once daily, beginning on Cycle 1, on Days 1-21 of each 28-day cycle.
  • Fulvestrant injection — DRUG
    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.
  • Tamoxifen — DRUG
    As per clinical guidelines
  • Letrozole — DRUG
    As per clinical guidelines
  • Exemestane — DRUG
    As per clinical guidelines
  • Anastrozole — DRUG
    As per clinical guidelines

Study Details

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.

Key Dates

First listed
Aug 2, 2021
Start date
Mar 30, 2022
Status verified
Dec 2024
Primary completion
Sep 1, 2027
Completion
Sep 1, 2030

Study Design

Enrollment
1,100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard endocrine therapy
    Standard endocrine therapy will continue for up to 24 months on trial. Standard endocrine therapies include tamoxifen, and aromatase inhibitors (letrozole, anastrazole, exemestane).
  • Experimental: Palbociclib and fulvestrant
    Treatment 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.

Primary Outcome Measure

Incidence of positive ctDNA result during surveillance (Surveillance phase) [ Time Frame: Up to 36 months from entry to study ]

Central Contacts

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