Marker - Adjusted Therapy Comparing Adjuvant Elacestrant With Standard Endocrine Treatment in Genomically and/or Clinically High-risk ER+/HER2- eBC

Recruiting now · Phase 3

Conditions studied: Breast Cancer, HR+/HER2- Breast Cancer

In brief

In this clinical trial, the Sponsor plans to investigate whether patients with HR+/HER2- eBC identified during routine clinical assessments and treatments as having intermediate to high-risk (based on Oncotype DX® or similar tests and on response assessment to 2-6 weeks of preoperative ET) achieve a survival benefit from an initial 5-years use of elacestrant (with or without a CDK 4/6 inhibitor) followed by SoC ET for further 0-2.5 years in comparison to at least 5 up to 7.5 years SoC ET therapy (+/- CDK4/6 inhibitor). Based on several studies in the metastatic setting, it is reasonable to assume that the adjuvant use of elacestrant with or without CDK 4/6 inhibitors will prevent or delay the activation of mechanisms conferring resistance to ET (e.g., ESR1 mutations).

Key facts

Study ID

NCT07242352

Run by

Women's Cancer Study Group GmbH

People needed

1520

Starts

2026-04-29

Expected to finish

2033-09-30

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All patients, independent from gender
• Patient must be ≥18 years at diagnosis
• The patient must be capable of giving informed consent and be willing and able to comply with the requirements and restrictions in this protocol and accessible for treatment and follow-up
• Sign informed consent prior to any study-specific procedures.
• Histologically confirmed unilateral, primary invasive carcinoma of the breast Note: bilateral, multicentric, or multifocal carcinoma may only be included after consultation of Sponsor.
• Histologically confirmed diagnosis of primary hormone-receptor-positive (HR+) (i.e., oestrogen-receptor (ER) ≥ 10% and progesterone-receptor PR ≥ 10%) early breast cancer by local laboratory Note: ER positive according to ASCO / AGO Guidelines, ER 1-10% (low) is not defined as HR+.
• Patient has HER2-negative breast cancer defined as a negative in-situ hybridization test or an IHC status of 0, 1+, or 2+, if IHC is 2+, a negative in-situ hybridization (FISH, CISH, or SISH) test is required (based on the most recently analysed tissue sample and all tested by a local laboratory).
• No evidence of distant metastasis (confirmed by CT thorax / abdomen, X-ray chest, ultrasound liver, bone scan, or PET-CT, respectively, performed within clinical routine).
• High genomic risk assessment within clinical routine (Oncotype DX® preferred; In those cases, where Oncotype Dx® is not possible in clinical routine, Oncotype Dx® should be assessed retrospectively after inclusion of the patient and as a study specific measure, provided sufficient tumour tissue from primary diagnosis is available.)
• 10. Completed 2-6 weeks of endocrine induction treatment and Ki-67 response assessment Note: 2-4 weeks recommended, up to 6 weeks allowed. Endocrine induction is highly recommended, but if endocrine induction therapy could not be performed or ET response is not representative, clinical factors should be used.
• 11. Completed (neo)adjuvant chemotherapy, if applicable
• Completed radiotherapy, if applicable
• Patient meets any of the following three conditions at end of primary treatment (including endocrine induction treatment, biopsy/surgery, and if necessary, chemotherapy and radiotherapy and up to 12 months standard-of-care endocrine treatment, excluding previous treatment > 4 weeks with any SERD):
• Pathological Stage * Genomical High-Risk (Oncotype Dx®)** Age Clinical High-Risk Factors Stage I T1 N0
• RS>25 Any age High risk (≤ 1 factor applies):
• ET non-response (post ET Ki-67 >10%)***
• No Chemotherapy
• G3 or PR negative and Ki-67 >25%***
• Non-pCR after NACT*
• RS 16-25 Age <50 High risk (≤ 1 factor applies):
• ET non-response (post ET Ki-67 >10%)***
• No Chemotherapy
• G3 or PR negative and Ki-67 >25%***
• Non-pCR after NACT* Any genomic risk Any age G3 and Ki-67>40%
• Stage IIa with T2 N0

You may not qualify if…

• Known hypersensitivity to any of the compounds or incorporated substances of the IMPs
• Prior malignancy with a disease-free survival of <5 years, except curatively treated basalioma of the skin or pTis of the cervix uteri
• Any history of invasive cancer within the last 10 years Note: adequately treated, basal or squamous-cell skin carcinoma, non-melanomatous skin cancer, curatively resected cervical cancer, and contralateral DCIS treated by mastectomy (contralateral in relation to current invasive breast cancer diagnosis) are excepted. Previous ipsilateral DCIS, irrespective of treatment, is excluded!
• Patient with distant metastases of breast cancer beyond regional lymph nodes.
• Concurrent treatment with cytotoxic agents for any non-oncological reason unless clarified with sponsor
• Concurrent treatment with other experimental drugs
• Participation in another interventional clinical trial with or without any investigational, not marketed drug within 30 days or 5 half-lives of the respective drug, whichever is longer, prior to study entry. In case of other interventional trial contact Sponsor.
• Previous treatment (>4 weeks) with any SERD
• Concurrent pregnancy; patients of childbearing potential or potentially childbearing partners of male patients must implement a highly effective (less than 1% failure rate) non-hormonal contraceptive measures during the study treatment
• Breast feeding woman
• Use of oral, transdermal, injected, or implanted hormonal methods of contraception as well as hormonal replacement therapy (oestrogen or progesterone).
• Reasons indicating risk of poor compliance
• Patient not able to consent
• Patient has not recovered from clinical and laboratory acute toxicities related to prior anticancer therapies to NCI CTCAE version 5.0 Grade ≤ 1.
• Severe and relevant co-morbidity that would interact with the application of endocrine treatment of any kind or the participation in the study
• For patients planned for ribociclib treatment: Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality, including any of the following:
• history of myocardial infarction (MI), angina pectoris, symptomatic pericarditis, or coronary artery bypass graft (CABG) within 6 months prior to study entry,
• documented cardiomyopathy,
• left ventricular ejection fraction (LVEF) < 50 % as determined by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO),
• long QT syndrome, family history of idiopathic sudden death, congenital long QT syndrome, or any of the following:
• risk factors for Torsades de Pointe (TdP, polymorphic ventricular tachycardia in patients with long QT syndrome) including uncorrected hypokalaemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/ symptomatic bradycardia,
• concomitant medications with a known risk to prolong the QT interval and/or known to cause Torsades de Pointe that cannot be discontinued or replaced by safe alternative medication (e.g., within 5 half-lives or 7 days prior to starting study drug),
• inability to determine the QTcF interval,
• clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left-bundle branch block, high-grade AV block (e.g., bi-fascicular block, Mobitz type II, and 3rd-degree AV block),
• systolic blood pressure (SBP) > 160 or < 90 mmHg.

Where it is running

• Staedtisches Klinikum Lueneburg gGmbH Brustkrebszentrum Lueneburg — Lüneburg, Germany (enrolling)
• Universitaetsklinikum Tuebingen AöR Frauenklinik — Tübingen, Baden-Wurttemberg, Germany (enrolling)
• Klinikum Esslingen GmbH Klinik für Frauenheilkunde und Geburtshilfe — Esslingen am Neckar, Baden-Wüttemberg, Germany (enrolling)
• Praxis Fuer Interdisziplinaere Onkologie And Haematologie GbR — Freiburg im Breisgau, Baden-Wüttemberg, Germany (enrolling)
• Klinikum St Marien Amberg Klinik für Frauenheilkunde und Geburtshilfe — Amberg, Bavaria, Germany (enrolling)
• MKS St. Paulus GmbH Märkisches Brustzentrum — Schwerte, North Rhine-Westphalia, Germany (enrolling)
• Praxisnetz Hämatologie / internistische Onkologie — Troisdorf, North Rhine-Westphalia, Germany (enrolling)
• Marien-Hospital Witten Brustzentrum — Witten, North Rhine-Westphalia, Germany (enrolling)
• Klinikum Mutterhaus der Borromaeerinnen gGmbH — Trier, Rhineland-Palatinate, Germany (enrolling)
• Universitaetsklinikum Mannheim GmbH Frauenklinik — Mannheim, Baden-Wurttemberg, Germany (enrolling)
• Rotkreuzklinikum Muenchen gGmbH Interdisziplinäres Brustzentrum — München, Bavaria, Germany (enrolling)
• Haematologisch Onkologische Schwerpunktpraxis — Würzburg, Bavaria, Germany (enrolling)
• Medical University Of Lausitz Carl Thiem Frauenklinik — Cottbus, Brandenburg, Germany (enrolling)
• Hämatologische Onkologische Praxis im Medicum — Bremen, Free Hanseatic City of Bremen, Germany (enrolling)
• Gesundheitszentrum Wetterau gGmbH Gynäkologische Ambulanz — Bad Nauheim, Hesse, Germany (enrolling)
• Centrum für Hämatologie und Onkologie Bethanien — Frankfurt am Main, Hesse, Germany (enrolling)
• Elisabeth Krankenhaus GmbH Brustzentrum — Kassel, Hesse, Germany (enrolling)
• Medizinische Hochschule Hannover Klinik für Frauenheilkunde und Geburtshilfe Brustzentrum — Hanover, Lower Saxony, Germany (enrolling)
• Gemeinschaftspraxis Frauenärzte am Bahnhofsplatz — Hildesheim, Niedersachen, Germany (enrolling)
• Klinik Dr. Hancken GmbH — Stade, Niedersachen, Germany (enrolling)
• Johanniter GmbH Onkologisches Zentrum — Bonn, North Rhine-Westphalia, Germany (enrolling)
• Marienhospital Bottrop gGmbH Klinik für Gynäkologie und Geburtshilfe — Bottrop, North Rhine-Westphalia, Germany (enrolling)
• Klinikum Dortmund gGmbH Frauenklinik Dortmund — Dortmund, North Rhine-Westphalia, Germany (enrolling)
• Universitaetsklinikum Duesseldorf AöR Klinik für Frauenheilkunde und Geburtshilfe — Düsseldorf, North Rhine-Westphalia, Germany (enrolling)
• St.-Antonius-Hospital gGmbH Klinik für Hämatologie und Onkologie — Eschweiler, North Rhine-Westphalia, Germany (enrolling)

Full record on ClinicalTrials.gov

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