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

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

Trial Details

NCT ID
NCT04985266
Phase
PHASE2
Sponsor
Royal Marsden NHS Foundation Trust
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Palbociclib 125Mg Tab
  • Fulvestrant injection
  • Tamoxifen
  • Letrozole
  • Exemestane
  • Anastrozole
Locations (sample)
  • Angers, France|47.47156,-0.55202
  • Annecy, France|45.90878,6.12565
  • Avignon, France|43.94834,4.80892
  • Blois, France|47.59432,1.32912
  • Bordeaux, France|44.84124,-0.58046

Key Eligibility Criteria

  • 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 negat…

For full eligibility, visit ClinicalTrials.gov.

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