NCT02028364 (PEARL) is a Phase 2 clinical trial of Everolimus in Breast Cancer, sponsored by Jules Bordet Institute.

Who is sponsoring NCT02028364?

NCT02028364 is sponsored by Jules Bordet Institute.

What drugs are being tested in NCT02028364?

Interventions in NCT02028364: Everolimus, Exemestane.

What condition does NCT02028364 study?

NCT02028364 studies Breast Cancer.

Is NCT02028364 still recruiting?

NCT02028364 is currently completed. Last updated 24 August 2023.

Last reviewed 2023-08-24 · How we verify

NCT02028364: PEARL

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pet Imaging as a Biomarker in Hormone Refractory postmenopausaL Women

Completed Phase 2 Last updated 24 August 2023

What this trial tests

Phase 2 trial testing Everolimus in Breast Cancer in 55 participants. Completed in 9 August 2021.

Timeline

12 January 2014

Primary endpoint
6 July 2021

9 August 2021

Quick facts

Lead sponsor	Jules Bordet Institute
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	55
Start date	12 January 2014
Primary completion	6 July 2021
Estimated completion	9 August 2021
Sites	5 locations across Belgium

Drugs / interventions tested

Everolimus (everolimus) — full drug profile →
Exemestane (exemestane) — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →

Sponsor

Jules Bordet Institute

Who can join

18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Current status of PI3K-mTOR inhibition in hormone-receptor positive, HER2-negative breast cancer.
Sobhani N, Generali D, Zanconati F, Bortul M, et al · · 2018 · cited 8× · PMID 30622925 · DOI 10.5306/wjco.v9.i8.172

Verify or expand the search:

Other trials of Everolimus

Trials testing the same drug.

NCT07095933 — The Safety and Efficacy Evaluation of Everolimus as an Adjunctive Treatment for Focal Refractory Epilepsy · EARLY_PHASE1 · recruiting
NCT07318324 — Phase Ib Study of Avutometinib, Defactinib, and Everolimus in RAS Pathway Mutant Endometrial Cancer · Phase 1 · not yet recruiting
NCT07477548 — A Study to Evaluate the Efficacy and Safety of Everolimus in Patients With Teratment-refractory Vascular Anomalies · Phase 2 · not yet recruiting
NCT07405164 — Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043) · Phase 3 · recruiting
NCT06832189 — EVR and EPO for Liver Transplant Tolerance · Phase 1 · recruiting

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting

Other Jules Bordet Institute trials

Trials by the same sponsor.

NCT07455331 — Flash Radiotherapy for Skin Cancer · Phase 2 · not yet recruiting
NCT07431346 — Prophylactic Intervention for Dysgeusia in Head and Neck Cancer Patients Following Radio(Chemo)Therapy · NA · not yet recruiting
NCT06925984 — Stereotactic Radiotherapy for Oligoprogressive ER+/HER- Metastatic Breast Cancer, a Prospective Phase 2 Study (Oligopro- · NA · recruiting
NCT06523634 — Salvage Stereotactic Body Radiotherapy of the Prostate Bed for Biochemical Recurrence After Radical Prostatectomy. · NA · recruiting
NCT06227338 — ICG-fluorescence Imaging for Intraoperative Breast Cancer Margins Evaluation: a Dose-timing Study · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02028364 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Jules Bordet Institute
Last refreshed: 24 August 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02028364.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing