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Breast CancerPhase 2NCT02806050

Palbociclib and FES PET

A Phase 2 study testing Palbociclib, FES PET and Letrozole in people with Breast Cancer, run by University Medical Center Groningen at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Palbociclib, FES PET and Letrozole
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteNetherlands
Study dates
16 Sep 2016to 28 Sep 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • Lipase/amylase <1/5 x ULN
  • Prothrombin time, partial thromboplastin time and INR <1.5 x ULN
  • ECOG performance 0-2
  • Signed written informed consent
  • Able to comply with the protocol
  • Age ≥18 years

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • University Medical Center Groningen

    Groningen, 9713 GZ

Other trials in Netherlands

About this study

Official title: Early Identification of Patients Who Benefit From Palbociclib in Addition to Letrozole

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.

Read the detailed description

To evaluate in a feasibility study whether low uptake on FES-PET at baseline is related to non response to letrozole plus palbociclib treatment. The investigators will perform this feasibility study in 15 patients with metastatic breast cancer, eligible for letrozole and palbociclib therapy.

All patients will be treated with letrozole 2.5mg daily continuously throughout a 28-day cycle. This is combined with palbociclib 125 mg daily for 21 consecutive days followed by 7 days off treatment. At baseline all patients will have a FES PET scan. Currently the combination with palbociclib and letrozole has been approved by the FDA as initial endocrine-based therapy for postmenopausal women with ER positive HER2 negative advanced breast cancer. This is based on improved progression free survival with 10 months compared to endocrine therapy alone in both first and second line hormonal treatment for ER-positive metastatic breast cancer. In Europe, approval is expected late 2016. Therefore, in this study, all patients will receive a (presumably effective) treatment combination, that patients do not have standard access to in the Netherlands yet. In addition to the standard control visits to the clinic, two extra visits will be performed as part of the study: for screening and for the FES-PET scan. In the future, this study may potentially contribute to improved selection of patients for this combination treatment. This is of relevance in view of optimal treatment for individual patients, avoiding unnecessary toxicity and financial burden.

Conditions
Breast Cancer
Being tested
Palbociclib, FES PET, Letrozole
Keywords
FES PET, Palbociclib
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PalbociclibDrug

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

  • FES PETDevice

    all patients will have a FES PET at baseline

  • LetrozoleDrug

    all patients will be treated with Letrozole daily until progression

Study groups in NCT02806050
Study groupRoleWhat they receive
Palbociclib and FES PETExperimentalTo evaluate whether low uptake on FES-PET at baseline is related to non-response to letrozole plus palbociclib treatment.
Receives: Drug: Palbociclib; Device: FES PET; Drug: Letrozole

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 8 weeks after start of treatment

Secondary outcomes (2)

  1. quantitative FES-uptake and correlation with progression free survival

    Measured: 6 months

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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2016 (estimated)
  2. Study start16 Sep 2016
  3. Primary completion28 Sep 2022
  4. Study completion28 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02806050
Sponsor's protocol ID
201600066
Status last verified
Oct 2022
First submitted
17 May 2016
Last updated
12 Oct 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 31891878

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Palbociclib, FES PET and Letrozole in people with Breast Cancer, run by University Medical Center Groningen at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The relation between low uptake on FES-PET to response per lesion (time frame: 8 weeks after start of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02806050, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.

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