Study on Elacestrant for Treating ER+/HER2- Breast Cancer in Patients with ctDNA Relapse

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What is this study about?

This clinical trial is focused on studying the treatment of breast cancer, specifically in patients who have a type of breast cancer known as ER+/HER2-. This means the cancer cells have receptors for estrogen but not for a protein called HER2. The study is investigating a medication called elacestrant, which is being compared to standard endocrine therapy. Endocrine therapy is a treatment that blocks or lowers the amount of hormones in the body to slow down or stop the growth of cancer. The purpose of the study is to see if elacestrant can delay the spread of cancer to other parts of the body or prevent death in patients who have a relapse detected by a test called ctDNA, which looks for cancer DNA in the blood.

Participants in the study will be randomly assigned to receive either elacestrant or one of the standard endocrine therapies, which include medications like tamoxifen, anastrozole, exemestane, and letrozole. Some patients may also receive additional treatments such as leuprorelin, goserelin, or triptorelin, which are used to lower hormone levels in the body. The study will last for a period of up to 104 weeks, during which the effects of the treatments will be monitored. The study aims to determine which treatment is more effective in preventing the cancer from spreading or causing death.

Throughout the study, participants will have regular check-ups and tests to monitor their health and the progress of the treatment. These tests may include imaging scans like MRI or CT scans, which use magnetic fields or X-rays to create detailed pictures of the inside of the body. The study will also collect information on the safety of the treatments and how they affect the quality of life of the participants. The results of this study could help improve treatment options for patients with this type of breast cancer in the future.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including a positive test for circulating tumor DNA (ctDNA) and a history of ER positive, HER2 negative breast cancer.

Participants must have completed certain prior treatments and be planning to continue with adjuvant endocrine therapy.

2 randomization

Participants are randomly assigned to one of two groups: one receiving elacestrant and the other receiving standard endocrine therapy.

The goal is to compare the effectiveness of elacestrant in delaying distant metastasis or death.

3 treatment phase

Participants in the elacestrant group take the medication orally. The dosage and frequency are determined by the study protocol.

Participants in the standard therapy group receive one of the following medications: tamoxifen, anastrozole, letrozole, exemestane, or elacestrant, depending on their specific treatment plan.

Additional medications such as leuprorelin, goserelin, or triptorelin may be administered via injection if required.

4 monitoring and follow-up

Participants undergo regular monitoring to assess the effectiveness of the treatment and to check for any side effects.

This includes imaging tests and blood tests to track the presence of ctDNA and any signs of metastasis.

5 completion of the study

The study is expected to continue until May 2032, with participants being followed up for outcomes such as distant metastasis-free survival and overall survival.

Participants’ experiences and outcomes are documented to evaluate the safety and effectiveness of the treatments.

Who Can Join the Study?

  • Patients must have breast cancer that is ER positive and HER2 negative. This means the cancer cells have certain characteristics: ER positive means at least 10% of the cells have estrogen receptors, and HER2 negative means the cells have a low score on specific tests.
  • Patients can be either female (both pre- and postmenopausal) or male.
  • Patients must be at least 18 years old.
  • Patients must have an elevated risk of recurrence after treatment for early breast cancer. This means they have certain stages of cancer or have completed specific chemotherapy treatments.
  • Patients must have received at least 4.5 years and up to 7 years of endocrine therapy (ET) and plan to continue it during the screening phase. Endocrine therapy is a treatment that blocks hormones that can help cancer grow.
  • Patients must have a ctDNA positive result according to a specific test. ctDNA is a type of DNA found in the blood that can indicate cancer.
  • Patients must be receiving adjuvant ET at the time of the ctDNA positive test. Adjuvant ET is additional hormone therapy given after the main treatment to lower the risk of cancer returning.
  • Patients must not have any locoregional or metastatic disease. This means the cancer has not spread to nearby areas or other parts of the body.
  • Patients must have an ECOG performance status of 0-1. This is a scale that measures how well patients can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
  • Patients must have adequate organ function. This means their organs are working well enough to handle the treatment.
  • Women of childbearing potential must have a negative pregnancy test before starting the trial.
  • Patients must provide a tumor sample from a previous biopsy or surgery. This sample must meet certain size and cellularity requirements.
  • Patients must give written informed consent to participate, following specific guidelines and regulations.

Who Cannot Join the Study?

  • Patients who have a different type of cancer other than breast cancer.
  • Patients who are not experiencing a ctDNA-relapse. This means that there is no detectable cancer DNA in their blood after treatment.
  • Patients who are not diagnosed with ER+/HER2- breast cancer. This refers to a specific type of breast cancer that is positive for estrogen receptors (ER+) and negative for human epidermal growth factor receptor 2 (HER2-).
  • Patients who are not within the specified age range for the study.
  • Patients who do not meet the gender requirements for the study.
  • Patients who are considered part of a vulnerable population, which may include groups like pregnant women, children, or those unable to give consent.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Klinikum Nuernberg Nürnberg Germany
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l. Meldola Italy
Centre Hospitalier De La Cote Basque Bayonne France
Azienda USL IRCCS Di Reggio Emilia Reggio Emilia Italy
Azienda Ospedaliero Universitaria Parma Parma Italy
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Technische Universitaet Dresden Dresden Germany
Rijnstate Ziekenhuis Stichting Arnhem The Netherlands
Universitaetsklinikum Aachen AöR Aachen Germany
Medizinische Hochschule Hannover Hanover Germany
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Universitario Y Politecnico La Fe Valencia Spain
Institut Catala D’oncologia L'hospitalet De Llobregat Spain
Grand Hopital De Charleroi Charleroi Belgium
Hospital Universitario Hm Sanchinarro Madrid Spain
Hospital Quironsalud Sagrado Corazon Sevilla Spain
Stichting Viecuri Medisch Centrum voor Noord-Limburg Venlo The Netherlands
Hospital Universitario Virgen De Las Nieves Granada Spain
Hospital Universitario De Navarra Pamplona Spain
Linac-Pet Scan Opco Limited Limassol Cyprus
Soedra Aelvsborg Hospital Vaestra Goetalandsregionen Boras Sweden
Flevoziekenhuis Stichting Almere The Netherlands
Region Skane Skanes Universitetssjukhus Lund Sweden
Cliniques Universitaires Saint-Luc Woluwe-Saint-Lambert Belgium
Institut Jules Bordet Anderlecht Belgium
General University Hospital Of Larissa Larissa Greece
Virgen del Rocío University Hospital Sevilla Spain
Centre Hospitalier Et Universitaire De Limoges Limoges France
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Amsterdam UMC Amsterdam The Netherlands
Karolinska University Hospital Solna Sweden
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Hospital Universitario De Cruces Barakaldo Spain
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
IRCCS Ospedale Policlinico San Martino Genoa Italy
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida Lleida Spain
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Hospices Civils De Lyon Lyon France
Medical Center Haaglanden Leidschendam The Netherlands
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Ramsay Generale De Sante Bayonne France
St Vincent’s University Hospital Dublin Ireland
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione Pavia Italy
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Azienda Ospedaliera Papa Giovanni XXIII Bergamo Italy
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Azienda Ospedaliero Universitaria Careggi Florence Italy
Oncopole Claudius Regaud Toulouse France
Katholieke Universiteit te Leuven Leuven Belgium
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital Santa Maria Della Misericordia Perugia Italy
Algemeen Ziekenhuis Delta Roeselare Belgium
University Childrens Hospital Queen Fabiola Brussels Belgium
Servei De Salut De Les Illes Balears Palma Spain
University Hospital Waterford Waterford Ireland
Centre Hospitalier Bethune Beuvry Beuvry France
CHU Croix Rousse-Lyon Lyon France
Institut Curie – Site Paris Paris France
Azienda Ospedaliero Universitaria Pisana Pisa Italy

Other Sites

Site Name City Country Status
Diagnostic & Therapeutic Center Of Athens Hygeia Single Member S.A. Athens Greece
Haematologie-Onkologie im Zentrum MVZ GmbH Augsburg Germany
Helios Universitaetsklinikum Wuppertal Wuppertal Germany
Gemeinschaftspraxis Dr. Pourfard & Dr. Uleer Hildesheim Germany
Ortenau Klinikum Offenburg Germany
Metropolitan General Hospital/Healthcare Facilities Operation And Management Single Member S.A Cholargos Greece
Hospital Da Luz S.A. Lisbon Portugal
Ospedale P. Pederzoli Casa Di Cura Privata S.p.A. Peschiera Del Garda Italy
AZ Turnhout Turnhout Belgium
MVM Medizinische Verwaltungs und Managementgesellschaft mbH Leer (ostfriesland) Germany
Mater Private Hospital Dublin Ireland
Adokqzejxj Msqsixj Hjloeutm Lecco Italy
Ubhwnlhqsvaowemswhpfq Uif Afi Ulm Germany
Kanfuapq Evglg vhd Bpsrulgj gdaqz Potsdam Germany
Hlnigmgb Dt Szzgb Mjcbc Emzeue Lisbon Portugal
Umfxjyc Ldeht Dj Sjive Df Glcckpamexcs Eenazl Vila Nova De Gaia Portugal
Eermhogvay Gnxawvf Cfrplr Og Ttnmczvhrlhs Thessaloniki Greece
Rvt Kojlmvq Ljclirgrfvhokiqixhgxhg gohlj Ludwigsburg Germany
Iptzuq Zybddsbhxs Rotterdam The Netherlands
Ajfsrmz Xoejm Ansmtokadxah Uztzkyyvefdtj Dz Mphaszv Ffwmfmws Pukwyjs Manresa Spain
Hsbdhra Dc Dcewq Dechy France
Chzikx Hnttwdhmzky Dr Jpwo Ekdl Tflgzl Calais France
Dsa Bdsqk Mmp Ghrs Muehlhausen/thueringen Germany
Gxj Goeblhybklowxfcfyu Raohhpswurzi gfkkg Weinheim Germany
Cwszth Hlrojiqoaii Df Bvhvqwmm Sdp Mkw Boulogne sur Mer France
Rctmrvwjncbypplyks gtzri Winnenden Germany
Eibgtokssvfkh Kcbnjdlftik Bfpghlgy Gmkzmybe gekrz Bergisch Gladbach Germany
Mmyoqjerpkytdp Bnkdlpw gvgfc Bottrop Germany
Kzckigdk Rygyrg Rheine Germany
Hzjsewcxxupvajxh ix Mhlkdqq Bremen Germany
Hjoxeus Jdtsbccw Haine-Saint-Paul Belgium
Suz Eoecprxaq Kyqtiepkpck Gadi Cologne Germany
Kdbuxhle Cjsgwllt getre Chemnitz Germany
Bvmn Ou Czjmkv Onzhmadq Cqhigb Strovolos Cyprus
Kodhkvyo Kxzjof Gxqj Kassel Germany
Hnjtgzwu Cbm Thnx Sgkg Lisbon Portugal
Snles Sdxy Jkdw Dp Rvwj Reus Spain
Sus Lavkpzpcghnk Hejrjpsl Syke Thessaloniki Greece
Aagbbpk Heogfdsp Athens Greece
Iynkqnos Dd Cnrunelpyyev Dg Bxemeqcub Dijon France
Abrkpchs Zlibdgomfi Krsqg Brasschaat Belgium
Ccxtqg Huvwvhapnga Usxduyxxyksgr Doxqjn Guhilrm Snkiyhyytdaswflszvyuveuebg Namur Belgium
Agrvljwz Zhswqrjxnd Gobbszfia Kortrijk Belgium
Ocqccbxt Mnygj Syxeleb Dc Lazqvme Legnago Italy
Cgc Vatxboxt Verviers Belgium
Ifqxscbqrhf Dy Nvcyt Nancy France
Sozurrl Dk Rwqicdhpz Odsiptvyetk Clmtterq 3f Chambray Les Tours France
Arrwnps Umu Iyehm Du Rrrcxs Eyykki Guastalla Italy
Bgifmk Hvokwxtb Dublin Ireland
Unsrieecuj Dxnya Sfxjb Dp Clivwczs Cagliari Italy

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
15.11.2023
Cyprus Cyprus
Recruiting
15.11.2023
France France
Recruiting
15.11.2023
Germany Germany
Recruiting
15.11.2023
Greece Greece
Recruiting
15.11.2023
Ireland Ireland
Recruiting
15.11.2023
Italy Italy
Recruiting
15.11.2023
Portugal Portugal
Recruiting
15.11.2023
Spain Spain
Recruiting
15.11.2023
Sweden Sweden
Recruiting
15.11.2023
The Netherlands The Netherlands
Recruiting
15.11.2023

Trial locations

Elacestrant is a medication being studied for its potential to treat breast cancer that is positive for estrogen receptors (ER+) and negative for human epidermal growth factor receptor 2 (HER2-). This medication is being tested to see if it can delay the spread of cancer to other parts of the body or prevent death in patients who have experienced a relapse detected by circulating tumor DNA (ctDNA).

Standard Endocrine Therapy refers to the usual treatment given to patients with ER+ breast cancer. This therapy typically involves medications that block the effects of estrogen, a hormone that can promote the growth of breast cancer cells. The trial is comparing the effectiveness of elacestrant against these standard treatments to see which is more effective in delaying cancer progression or death.

Breast cancer – Breast cancer is a disease where cells in the breast grow uncontrollably, forming a tumor that can often be felt as a lump. It typically begins in the ducts or lobules of the breast and can spread to other parts of the body if not managed. The progression of breast cancer can vary, with some types growing slowly and others more rapidly. It is often classified by the presence of hormone receptors, such as estrogen receptor-positive (ER+) or human epidermal growth factor receptor 2-negative (HER2-), which can influence its behavior and response to treatment. Symptoms may include changes in breast shape, skin dimpling, or nipple discharge. Early detection through screening can improve outcomes by identifying the disease before it spreads.

Trial ID:
2022-501453-36-00
Protocol code:
EORTC 2129-BCG
NCT ID:
NCT05512364
Trial Phase:
Therapeutic confirmatory (Phase III)

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