Actively Recruiting
Marker - Adjusted Therapy Comparing Adjuvant Elacestrant With Standard Endocrine Treatment in Genomically and/or Clinically High-risk ER+/HER2- eBC
Led by West German Study Group · Updated on 2026-05-06
1520
Participants Needed
1
Research Sites
387 weeks
Total Duration
On this page
Sponsors
W
West German Study Group
Lead Sponsor
B
Berlin-Chemie Menarini
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Marker - Adjusted Therapy Comparing Adjuvant Elacestrant With Standard Endocrine Treatment in Genomically and/or Clinically High-risk ER+/HER2- eBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients of any gender
- Age 18 years or older at diagnosis
- Able to give informed consent and comply with study requirements
- Signed informed consent before any study-specific procedures
- Histologically confirmed unilateral, primary invasive HR+ (ER 25 10%, PR 25 10%) and HER2-negative breast cancer
- No evidence of distant metastasis
- High genomic risk based on clinical routine tests (preferably Oncotype DX)
- Completed 2-6 weeks of endocrine induction treatment with Ki-67 response assessment
- Completed (neo)adjuvant chemotherapy and radiotherapy if applicable
- Meet specified high-risk criteria based on clinical stage, genomic risk, and endocrine therapy response
- No contraindications to standard endocrine treatment, elacestrant, or ribociclib if indicated
- Tumor samples available for central pathology review if possible
- ECOG performance status 24 1 or Karnofsky Index 25 80%
- Laboratory values within specified limits (e.g., neutrophils, platelets, hemoglobin, liver and kidney function, lipid levels)
- Normal electrocardiogram within 6 weeks prior to randomization
- Ability to swallow tablets
- Use of effective contraception as detailed for females and males of childbearing potential
You will not qualify if you...
- Known allergy or hypersensitivity to study drugs or ingredients
- Prior malignancy within 5 years except certain skin or cervical cancers
- History of invasive cancer within 10 years except specific exceptions
- Presence of distant metastases beyond regional lymph nodes
- Current treatment with cytotoxic agents for non-oncological reasons
- Concurrent use of other experimental drugs
- Participation in another interventional clinical trial within 30 days or 5 half-lives
- Previous treatment longer than 4 weeks with any selective estrogen receptor degrader (SERD)
- Current pregnancy or breastfeeding
- Use of hormonal contraception or hormonal replacement therapy
- Poor compliance risk or inability to consent
- Unrecovered acute toxicities from prior anticancer therapies above grade 1
- Severe comorbidities affecting endocrine treatment or study participation
- Significant uncontrolled heart disease or cardiac abnormalities if planned for ribociclib
- Gastrointestinal conditions affecting drug absorption
- Uncontrolled infections requiring intravenous treatment
- Known active HIV, hepatitis B, or hepatitis C infection
- Receipt of live vaccines within 30 days prior to randomization
- Legal or court-ordered institutionalization
AI-Screening
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Trial Site Locations
Total: 1 location
1
Brustzentrum Niederrhein, Johanniter Bethesda Krankenhaus
Mönchengladbach, North Rhine-Westphalia, Germany, 41061
Actively Recruiting
Research Team
A
Anja Braschoß
CONTACT
M
Marina Mangold, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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