Palbociclib and FES PET

NCT02806050 | Completed Phase 2 DMC

• 1 other identifier: 201600066
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

FES PET; Palbociclib

Outcome Measures

Primary Outcomes (1)

• The relation between low uptake on FES-PET to response per lesion

  8 weeks after start of treatment

Secondary Outcomes (2)

• quantitative FES-uptake and correlation with progression free survival

  6 months

• analysis of circulating tumor DNA and correlation with FES-PET results and progression free survival

  6 months

Study Arms (1)

Palbociclib and FES PET

EXPERIMENTAL

To evaluate whether low uptake on FES-PET at baseline is related to non-response to letrozole plus palbociclib treatment.

Drug: Palbociclib; Device: FES PET; Drug: Letrozole

Interventions

Palbociclib DRUG

all patients will be treated with palbociclib, on a 3 weeks on, 1 week off cycle until progression

Palbociclib and FES PET

FES PET DEVICE

all patients will have a FES PET at baseline

Palbociclib and FES PET

Letrozole DRUG

all patients will be treated with Letrozole daily until progression

Palbociclib and FES PET

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• Patients with ER positive (i.e. \>1% staining), HER2 negative metastatic breast cancer (preferably assessment on fresh metastasis biopsy, alternatively archival metastasis biopsy)
• Post-menopausal status defined as:
• Age ≥60 years
• Previous bilateral oophorectomy
• Age \<60 years and amenorrhea for \>12 months in the absence of interfering hormonal therapies (such as LH-RH agonists and ER-antagonists
• Age \<60 years using ER antagonists should have amenorrhea for \>12 months and FSH \>24U/L and LH\>14U/L
• Adequate bone marrow and organ function defined as follows:
• Absolute neutrophil count \> 1.5 x 109/L
• Platelet count \>100 x 109/L
• White blood cell count \>3 x 109/L
• AST and ALT \<3.0 x upper limit of normal (ULN) or \<5 xULN in case of known liver metastases.
• Alkaline phosphatase \<2.5 x ULN
• Total serum bilirubin \< ULN or total bilirubin \<3.0 x ULN with direct bilirubin within normal range in patients with Gilbert's Syndrome
• Creatinine clearance \>50mL/min

You may not qualify if:

• A potential subject who meets any of the following criteria will be excluded from participation in this study:
• Life expectancy \< 3 months
• Evidence of central nervous system metastases
• Presence of life-threatening visceral metastases
• Prior use of CDK4/6 inhibitor
• Use of estrogen receptor ligands including estrogens, fulvestrant or tamoxifen \<6 weeks before study entry.
• Use of other anticancer therapy \< 2 weeks prior to start with palbociclib
• Concurrent malignancy
• Active cardiac disease or a history of cardiac dysfunction
• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

Related Publications (1)

• Boers J, Venema CM, de Vries EFJ, Glaudemans AWJM, Kwee TC, Schuuring E, Martens JWM, Elias SG, Hospers GAP, Schroder CP. Molecular imaging to identify patients with metastatic breast cancer who benefit from endocrine treatment combined with cyclin-dependent kinase inhibition. Eur J Cancer. 2020 Feb;126:11-20. doi: 10.1016/j.ejca.2019.10.024. Epub 2019 Dec 28.

  PMID: 31891878 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

palbociclib; Letrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• C. P. Schröder, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: June 20, 2016
• Study Start: September 16, 2016
• Primary Completion: September 28, 2022
• Study Completion: September 28, 2022
• Last Updated: October 12, 2022

Record last verified: 2022-10

Locations

NL (1)