TheranosticTrials.org

Clinical Trial · NCT02806050

Palbociclib and FES PET

Overview

The purpose is to evaluate whether non invasive in vivo imaging of the estrogen receptor (ER) presence in metastatic breast cancer patient by means of 18F-fluoro-estradiol (FES) positron emission tomography (PET) can be used to predict treatment response to palbociclib plus letrozole. As ER expression predicts response to palbociclib in metastatic breast cancer patients the investigators hypothesize that lesions with low uptake on FES-PET will not respond to the combination of letrozole plus palbociclib.

Sponsor

University Medical Center Groningen

Phase

Phase 2

Contacts

C. P. Schröder, MD, PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02806050

Drug / Compound

fluoroestradiol

Isotope(s):
Target(s):
  • Estrogen Receptor
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Post-menopausal status defined as:
  • Patients with ER positive (i.e. \>1% staining), HER2 negative metastatic breast cancer (preferably assessment on fresh metastasis biopsy, alternatively archival metastasis biopsy)
  • Creatinine clearance \>50mL/min
  • Previous bilateral oophorectomy
  • Platelet count \>100 x 109/L
  • Prothrombin time, partial thromboplastin time and INR \<1.5 x ULN
  • AST and ALT \<3.0 x upper limit of normal (ULN) or \<5 xULN in case of known liver metastases.

Exclusion

  • Presence of life-threatening visceral metastases
  • Use of estrogen receptor ligands including estrogens, fulvestrant or tamoxifen \<6 weeks before study entry.
  • Prior use of CDK4/6 inhibitor
  • Use of other anticancer therapy \< 2 weeks prior to start with palbociclib
  • Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior to the start of treatment that are known strong inducers or inhibitors of CYP3A4/5, known risk to prolong the QT interval or induce Torsades de Pointes, or narrow therapeutic window and are predominantly metabolized through CYP3A4/5.
  • A potential subject who meets any of the following criteria will be excluded from participation in this study:
  • Active cardiac disease or a history of cardiac dysfunction
  • Evidence of central nervous system metastases