Study of Imlunestrant, Fulvestrant, Exemestane, and Abemaciclib for Patients with Advanced Estrogen Receptor Positive, HER2 Negative Breast Cancer

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What is this study about?

This clinical trial is focused on studying treatments for breast cancer, specifically in patients with a type of breast cancer that is estrogen receptor positive (ER+) and HER2 negative (HER2-). These patients have cancer that is either locally advanced or has spread to other parts of the body. The study involves several treatments: a new drug called imlunestrant, a combination of imlunestrant with another drug called abemaciclib, and standard treatments chosen by the study doctor, which may include either fulvestrant or exemestane.

The purpose of the study is to compare how well these treatments work in controlling the cancer. Participants will be randomly assigned to one of the treatment groups. Some will receive imlunestrant alone, some will receive the standard treatment chosen by the doctor, and others will receive a combination of imlunestrant and abemaciclib. The study will monitor the progress of the cancer and how it responds to the treatment over time.

Throughout the study, participants will take the medications either as tablets or as injections, depending on the treatment group they are in. The study aims to provide valuable information on the effectiveness of these treatments in managing advanced breast cancer, particularly in patients who have already been treated with drugs that block estrogen production.

1 joining the study

Upon joining the study, the patient is assigned to one of three groups. Each group receives a different treatment regimen for advanced breast cancer that is positive for estrogen receptors and negative for HER2.

The study involves comparing the effectiveness of different treatments in patients who have previously been treated with hormone therapy.

2 treatment group assignment

The patient is randomly assigned to one of the following treatment groups:

Arm A: Receives imlunestrant, a medication taken orally.

Arm B: Receives the investigator’s choice of endocrine therapy, which could be either fulvestrant (administered as an injection) or exemestane (taken orally).

Arm C: Receives a combination of imlunestrant and abemaciclib, both taken orally.

3 medication administration

For patients in Arm A, imlunestrant is taken orally as prescribed by the study protocol.

For patients in Arm B, if fulvestrant is chosen, it is administered as an injection. If exemestane is chosen, it is taken orally.

For patients in Arm C, both imlunestrant and abemaciclib are taken orally according to the study’s dosing schedule.

4 monitoring and assessments

Throughout the study, the patient’s health and response to treatment are closely monitored.

Regular assessments are conducted to evaluate the progression of the disease and the effectiveness of the treatment.

5 study duration

The study is expected to continue until February 15, 2027.

The duration of participation for each patient may vary depending on individual response to treatment and other factors.

Who Can Join the Study?

  • Participants must have HR+ HER2- breast cancer. This means the cancer grows in response to hormones but does not have a protein called HER2.
  • Participants must have cancer that is advanced or has spread to another part of the body. This means the cancer is in a later stage or has moved from its original location.
  • Participants must have already received a drug that blocks the production of estrogen. Estrogen is a hormone that can help some breast cancers grow.
  • Participants must have adequate body organ function. This means the organs in the body, like the liver and kidneys, are working well enough.
  • Participants must be in fair to good health. This means they should generally feel well and not have serious health problems.
  • Participants must be able to swallow capsules/tablets. This means they can take medicine by mouth in pill form.

Who Cannot Join the Study?

  • Patients who have a different type of cancer other than breast cancer cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not part of the specified clinical trial groups cannot participate.
  • Patients who are not female or male, as specified by the study, cannot participate.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Institut De Cancerologie De Lorraine Vandoeuvre Les Nancy France
Frisius Heerenveen The Netherlands
Medical University Of Vienna Vienna Austria
Hospital Clinico San Carlos Madrid Spain
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
University Hospital Maastricht Maastricht The Netherlands
Katholieke Universiteit te Leuven Leuven Belgium
Institut Curie – Site Paris Paris France

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Institut Jules Bordet Anderlecht Belgium
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Universitair Ziekenhuis Gent Gent Belgium
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Hospital Universitari Dexeus Grupo Quironsalud Barcelona Spain
Hospital San Pedro De Alcantara Caceres Spain
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
Vitaz Sint-Niklaas Belgium
Centre De Cancerologue Du Grand Montpellier Montpellier France
SCRI CCCIT Ges.m.b.H. Salzburg Austria
University General Hospital Of Heraklion Heraklion Greece
RKH Klinken Ludwigsburg-Bietigheim gGmbH Ludwigsburg Germany
Polyclinique De Blois La Chaussee St Victor France
Saint Savvas Oncology Hospital Athens Greece
General Hospital Of Thessaloniki Papageorgiou Thessaloniki Greece
Virgen del Rocío University Hospital Sevilla Spain
Universitaetsklinikum Erlangen AöR Erlangen Germany
Alexandra Hospital Athens Greece
IRCCS Ospedale Policlinico San Martino Genoa Italy
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida Lleida Spain
Centre Hospitalier De La Cote Basque Bayonne France
Hospital Universitario De Canarias La Laguna Spain
Vrije Universiteit Brussel Jette Belgium
Clinique Victor Hugo Le Mans France
Centre Regional Lutte Contre Le Cancer STRASBOURG, Alsace France
Agaplesion Frankfurter Diakonie Kliniken gGmbH Frankfurt Germany
Onkologiezentrum Donauwörth Donauwörth Germany
Btpcndjb Uuhgfgmujy Hvhqhnqz Cjtbjr Besançon France
Mdewykv Uznxxgustq Oa Gjbd Graz Austria
Auxwhh Mzzewqn Cokudu Smur Thessaloniki Greece
Kmqczlpe did Uzuvnwdsniaj Mbefocaw Asl Munich Germany
Hvjabttd Dn Lw Ssyde Ckll I Sqfu Pqm Barcelona Spain
Kwrpcjiw Emhtrpsuxfrdlpzwuonyyrzl Htglpwwrinlxbnuvr Essen Germany
Hvrgbjon Vuwd dojhekbj Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
04.10.2021
Belgium Belgium
Not recruiting
04.10.2021
France France
Not recruiting
04.10.2021
Germany Germany
Not recruiting
04.10.2021
Greece Greece
Not recruiting
04.10.2021
Italy Italy
Not recruiting
04.10.2021
Spain Spain
Not recruiting
04.10.2021
The Netherlands The Netherlands
Not recruiting
04.10.2021

Trial locations

Imlunestrant is a medication being studied for its potential to treat certain types of breast cancer. It works by targeting and blocking estrogen receptors, which can help slow down or stop the growth of cancer cells that rely on estrogen to grow.

Fulvestrant is a type of endocrine therapy used in the treatment of breast cancer. It works by blocking and degrading estrogen receptors, which can help prevent the cancer cells from receiving the signals they need to grow.

Exemestane is another form of endocrine therapy used to treat breast cancer. It functions by reducing the amount of estrogen produced in the body, which can help slow the growth of cancer cells that depend on estrogen.

Abemaciclib is a medication used in combination with other therapies to treat breast cancer. It works by inhibiting certain proteins that are involved in cell division, thereby slowing down the growth and spread of cancer cells.

Investigated diseases:

Breast Cancer – Breast cancer is a disease where cells in the breast grow uncontrollably. It typically begins in the ducts or lobules of the breast. As the disease progresses, it can spread to nearby tissues and lymph nodes. The growth of cancer cells can form a lump or mass in the breast. Over time, the cancer may metastasize to other parts of the body. The progression and symptoms can vary depending on the type and stage of the cancer.

Trial ID:
2023-506786-63-00
Protocol code:
J2J-OX-JZLC
NCT ID:
NCT04975308
Trial Phase:
Therapeutic confirmatory (Phase III)

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