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Medical Imaging to Re-evaluate Elacestrant Clinical Usage

NCT07753954 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-08-10

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate whether elacestrant, an oral selective oestrogen receptor degrader, can improve outcomes in patients with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer without detectable ESR1 mutation after progression on endocrine therapy plus a CDK4/6 inhibitor.

The study aims to answer two key questions:

* Does \[18F\]-fluor-oestradiol positron emission tomography/computed tomography (18F-FES-PET/CT) result (homogeneous vs. heterogeneous) determine the efficacy of elacestrant in participants with advanced/metastatic ER-positive breast cancer and ESR1-mut-nd?
* Does 18F-FES-PET/CT imaging predict patient outcomes, including progression-free survival, overall survival, or tumor response?

There is no comparison group in this study. All participants receive elacestrant. Researchers will compare outcomes in people who have different levels of estrogen-receptor heterogeneity on FES-PET/CT imaging.

Participants in the study will:

* Take elacestrant 345 mg orally once a day, in 28-day treatment cycles (the dose may be lowered to 258 mg if needed due to side effects).
* Undergo 18F-FES-PET/CT and 18F-FDG-PET/CT imaging both at the beginning of the study and as part of routine clinical evaluation every 8 weeks
* Undergo blood sample collection every 8 weeks
* If selected for a sub-study, undergo an additional FES-PET/CT scan 4 weeks after starting treatment

Conditions

  • ER+ / HER2- Advanced Breast Cancer

Interventions

DRUG

Elacestrant

Elacestrant is an orally available tetrahydronaphthalene compound that acts as selective oestrogen receptor alpha (ERα) antagonist with receptor degrading activity (e.g., selective oestrogen receptor degrader, SERD) and is being developed as a monotherapy agent and in combinations for the treatment of oestrogen receptor (ER) positive breast cancer.

Sponsors & Collaborators

Principal Investigators

  • Martine Piccart, MD, PhD · Jules Bordet Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-13
Primary Completion
2031-08-19
Completion
2031-08-19
FDA Drug
Yes

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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 NCT07753954 on ClinicalTrials.gov