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Palbociclib and FES PET

NCT02806050 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-10-12

No results posted yet for this study

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

Interventions

DRUG

Palbociclib

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

DEVICE

FES PET

all patients will have a FES PET at baseline

DRUG

Letrozole

all patients will be treated with Letrozole daily until progression

Sponsors & Collaborators

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • C. P. Schröder, MD, PhD · University Medical Center Groningen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-16
Primary Completion
2022-09-28
Completion
2022-09-28

Countries

  • Netherlands

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02806050 on ClinicalTrials.gov