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Breast CancerPhase 2PEARLNCT02028364

Pet Imaging as a Biomarker in Hormone Refractory postmenopausaL Women

A Phase 2 study testing Everolimus and Exemestane in people with Breast Cancer, run by Jules Bordet Institute at 5 sites in Belgium.

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

This is a prospective, single arm trial in which patients with locally advanced or metastatic endocrine receptor positive and HER2 negative breast cancer refractory to non-steroidal aromatase inhibitors (NSAI) will receive Everolimus 10mg orally daily given in conjunction with exemestane 25mg orally daily until… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Everolimus and Exemestane
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
5 sitesBelgium
Study dates
12 Jan 2014to 9 Aug 2021
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult women (≥18 years of age) with locally advanced or metastatic breast cancer not amenable to curative treatment by surgery or radiotherapy.
  • Histological or cytological confirmation of estrogen-receptor positive (ER+), HER2 negative breast cancer.
  • Postmenopausal female defined as:
  • Age ≥55 years and one year or more of amenorrhoea
  • Age <55 years and one year or more of amenorrhoea, with an estradiol assay <20pg/ml
  • Surgical menopause with bilateral oophorectomy NOTE: Ovarian radiation or treatment with a luteinizing hormone-releasing hormone (LHRH) agonist (goserelin or leuprolide) is not permitted for induction of ovarian suppression.
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  • Breast cancer that is refractory to non-steroidal aromatase inhibitors (NSAI) (i.e. anastrozole or letrozole) defined as:
  • Recurrence while on, or within 12 months of end of adjuvant treatment with anastrozole or letrozole; OR
  • Progression while on, or within one month of end of anastrozole or letrozole or treatment for locally advanced or metastatic breast cancer.
  • NOTE: Letrozole or anastrozole do not have to be the last treatment prior to enrolment.
  • FDG-PET measurable disease defined as: at least one target lesion fulfilling following criteria:
  • Size ≥1.5cm; AND
  • FDG-PET avid lesion with uptake above the background liver uptake as described below: i.e. with a marked accumulation of FDG, at least 1.5-fold greater than liver SUV mean + 2 SDs (in 3cm spherical ROI in normal right lobe of liver). If liver is abnormal, target lesion should have uptake > 2.0 x SUV mean of blood pool in 1cm diameter ROI in descending thoracic aorta)
  • NB:
  • The target lesion can be a bone metastasis if it fulfils the above mentioned criteria.
  • In the case the target lesion is a lymph node, the small axis should be ≥ 1.5cm.
  • Radiological or clinical evidence of recurrence or progression on last systemic therapy prior to enrolment.
  • Adequate bone marrow function as shown by:
  • Haemoglobin (HgB) ≥9.0 g/dL
  • ANC ≥1,500/mm3 (≥1.5 x 109/L)
  • Platelets ≥100,000/mm3 (≥100x 109/L)
  • Adequate liver function as shown by:
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5xULN (or ≤5 if hepatic metastases are present)
  • Total serum bilirubin ≤1.5 x ULN (≤3 ULN for patients known to have Gilbert Syndrome)
  • Adequate renal function as shown by Serum creatinine ≤1.5 x ULN
  • Fasting serum cholesterol, triglycerides and glucose
  • Fasting serum cholesterol ≤300 mg/dL or 7.75 mmol/L
  • Fasting triglycerides ≤2.5 x ULN
  • Fasting glucose < 1.5 x ULN
  • Eastern Co-operative Oncology Group (ECOG) performance status ≤ 2.
  • Written and signed informed consent obtained before any trial related activity.
  • Availability of a FFPE core of primary breast tumor
  • Possibility to obtain the mandatory blood samples for the translational research studies.
  • For patients with accessible metastatic lesions, possibility to obtain the mandatory biopsy (FFPE and frozen) of a metastatic lesion

Who cannot join

  • HER2-overexpressing patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive).
  • Patients with only non-measurable lesions by FDG-PET/CT (e.g. pleural effusion, ascites etc.).
  • Symptomatic visceral disease for example liver, pulmonary metastases or lymphangitis carcinomatosis.
  • Known hypersensitivity to mTOR inhibitors, e.g. sirolimus (rapamycin).
  • Another malignancy within 5 years prior to enrolment, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer.
  • Radiotherapy within four weeks prior to enrolment except in case of localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture, which can then be completed within two weeks prior to enrolment. Patients must have recovered from radiotherapy toxicities prior to enrolment.
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  • Currently receiving hormone replacement therapy, unless discontinued prior to enrolment.
  • Symptomatic brain metastases or other central nervous system metastases which are not controlled by local treatments.
  • Patients receiving concomitant immunosuppressive agents or chronic corticosteroid use at the time of study entry except in cases outlined below:
  • Topical applications (e.g. rash)
  • Inhaled sprays (e.g. obstructive airways disease)
  • Eye drops
  • Local injections (e.g. intra-articular)
  • Stable low dose of corticosteroids for at least two weeks before enrolment
  • Patients with known HIV seropositivity. Screening for HIV infection at baseline is not required
  • Acute and chronic, active infectious disorders (except for Hepatitis B and Hepatitis C positive patients).
  • Active bleeding diathesis, or on oral anti-vitamin K medication (except low dose warfarin, LMWH and acetylsalicylic acid or equivalent, as long as the INR is ≤ 2.0).
  • Any severe uncontrolled medical conditions such as:
  • Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤6 months prior to enrolment, uncontrolled cardiac arrhythmia
  • Uncontrolled diabetes as defined by fasting glucose ≥ 1.5 x ULN
  • Acute and chronic, active infectious disorders and non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy.
  • Symptomatic deterioration of lung function
  • Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A (Rifabutin, Rifampicin, Clarithromycin, Ketoconazole, Itraconazoleonazole, Voriconazole, Ritonavir, Telithromycin) within the last 5 days prior to enrolment.
  • History of non-compliance to medical regimens.
  • Patients unwilling or unable to comply with the protocol.
  • Concurrent anti-cancer treatment in another investigational trial, including hormonal therapy, immunotherapy or targeted agents other than those administered in this study.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Belgium5 sites

  • institut Jules Bordet

    Brussels, 1000

  • Cliniques Universtaires Saint-Luc

    Brussels, 1200

  • UZ Leuven

    Leuven, 3000

  • CHU Ambroise Paré

    Mons, 7000

  • Clinique et Maternité Sainte Elisabeth

    Namur, 5000

Other trials in Belgium

About this study

Official title: Pet Imaging as a Biomarker of Everolimus Added Value in Hormone Refractory postmenopausaL Women

This is a prospective, single arm trial in which patients with locally advanced or metastatic endocrine receptor positive and HER2 negative breast cancer refractory to non-steroidal aromatase inhibitors (NSAI) will receive Everolimus 10mg orally daily given in conjunction with exemestane 25mg orally daily until disease progression or treatment discontinuation for any other reasons. The main objectives are to evaluate if early metabolic response (MR) using FDG-PET/CT is associated with progression free survival (PFS) and overall survival (OS) in this population.

Tumour, metastatic lesions and blood samples will be collected during the treatment period in order to identify biomarkers predicting resistance to study treatment. Results will be correlated with the results of early FDG PET/CT data in order to better characterise the non-responders.

Conditions
Breast Cancer
Being tested
Everolimus, Exemestane
Keywords
Locally advanced breast cancer, HER2 negative, NSAI refractory, Metastatic breast cancer, Estrogen-receptor positive (ER+)
Medical subject headings
Breast Neoplasms

What participants receive

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

  • EverolimusDrug

    Also called Afinitor

    10mg orally daily

  • ExemestaneDrug

    Also called Aromasin, Exemestane Teva, Exemestane Sandoz, Exemarom,Exemestane Mylan, Exemestane Accord Healthcare

    25mg orally daily

Study groups in NCT02028364
Study groupRoleWhat they receive
Everolimus given in conjunction with exemestaneExperimentalEverolimus 10mg orally daily given in conjunction with exemestane 25mg orally daily until disease progression or treatment discontinuation for any other reasons.
Receives: Drug: Everolimus; Drug: Exemestane

What is being measured

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

  1. PFS based on RECIST criteria 1.1.

    To evaluate if early metabolic response (MR) using FDG-PET/CT is associated with progression free survival (PFS) in ER+, HER2 negative ABC or MBC patients treated with exemestane plus everolimus.

    Measured: 2.5 years from FPI

Secondary outcomes (3)

  1. Overall survival (OS)

    To evaluate if early metabolic response (MR) using FDG-PET/CT is associated with overall survival (OS) in ER+, HER2 negative locally advanced or MBC patients treated with exemestane plus everolimus.

    Measured: 2.5 years from first patient in

  2. * Proportion of FDG-PET/CT metabolic non-responders/FDG-PET/CT metabolic responders * Estimate the most suitable second FDG-PET/CT time point (2 weeks versus 4 weeks after initiation of treatment).

    FDG PET/CT will be done three times during the pilot phase of the study (first 30 patients): at baseline (at day 0, Day 14 and day 28). FDG PET/CT will be done twice during the extension phase: at baseline (at day 0, Day 14 or Day 28) depending the results of the pilot phase.

    Measured: Baseline, day 14, Day 28 and at progression

  3. Biomarker Assessment

    The aim is to identify biomarkers predicting resistance to exemestane and everolimus therapy by studying primary tumor, metastatic biopsies and serial plasma samples.

    Measured: baseline, day 14, day 28, every 12 weeks and at progression

Timeline

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

  1. First posted7 Jan 2014 (estimated)
  2. Study start12 Jan 2014
  3. Primary completion6 Jul 2021
  4. Study completion9 Aug 2021

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
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02028364
Sponsor's protocol ID
IJB-BCTL:20120306
Other IDs
2012-004860-22
Acronym
PEARL
Status last verified
Aug 2023
First submitted
20 Nov 2013
Last updated
24 Aug 2023
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Everolimus and Exemestane in people with Breast Cancer, run by Jules Bordet Institute at 5 sites in Belgium.

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 34 inclusion and 26 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 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Belgium. 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?

PFS based on RECIST criteria 1.1. (time frame: 2.5 years from FPI). 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 NCT02028364.

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 24 Aug 2023.

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