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An international, multicenter, randomised, superiority phase III, open label, 2-arm study to investigate distant metastasis free survival with elacestrant compared with standard endocrine therapy patients with ctDNA+ ER+/HER2- early breast cancer
EU CTIS ID: 2022-501453-36-00
What this study is testing
To evaluate whether elacestrant can delay occurrence of distant metastasis or death when compared to standard endocrine therapy in ER+/HER2- breast cancer patients with ctDNA-relapse.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- ctDNA screening phase: Female (both pre- and postmenopausal) or male patients with histologically confirmed ER positive (regardless of PR), HER2 negative breast cancer, according to local pathologist: ER-positive defined as ≥ 10% of cells staining positive for ER or Allred proportion score ≥3; HER2-negative defined as a score of 0, 1+ by immunohistochemistry (IHC) or a negative in situ hybridization (ISH) based on single-probe average HER2 copy number, as per American Society of Clinical Oncology guidelines
- ctDNA screening phase: Available tumour sample from resected or biopsied tissue, with a tumour content of ≥20% (30% preferred) either before or after macro dissection (if performed) and a cell viability of a minimum 100 cells.
- ctDNA screening phase: Written informed consent must be given according to ICH/GCP, and national/local regulations.
- Randomised trial: ctDNA positive according to the Signatera ctDNA assay (main study ctDNA test) or other ctDNA assay approved for diagnostic purposes.
- Randomised trial: Patients must receive adjuvant ET at the time of the ctDNA positive test
- ctDNA screening phase: Invasive multicentric / multifocal disease is allowed provided that all the tested foci are ER+ HER2-. A sample from the highest-risk one, according to the investigator decision based on the size and grade, should be sent to Natera to build the patient ctDNA assay.
You likely can't join if
- ctDNA screening phase: Suspected recurrent disease or known conflicts with the inclusion and exclusion criteria for the randomised trial
- Randomised trial: Uncontrolled significant active infections (≥ grade 3 according to CTCAE version 5), including active hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency Virus (HIV)
- Randomised trial: Coagulopathy or any history of coagulopathy within the past 6 months, including history of deep vein thrombosis or pulmonary embolism
- ctDNA screening phase: Prior treatment with any SERD or investigational ER antagonist
- ctDNA screening phase: Previous history of invasive breast cancer
- ctDNA screening phase: Previous history of any other malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
See the full eligibility criteria
Who can join
- ctDNA screening phase: Female (both pre- and postmenopausal) or male patients with histologically confirmed ER positive (regardless of PR), HER2 negative breast cancer, according to local pathologist: ER-positive defined as ≥ 10% of cells staining positive for ER or Allred proportion score ≥3; HER2-negative defined as a score of 0, 1+ by immunohistochemistry (IHC) or a negative in situ hybridization (ISH) based on single-probe average HER2 copy number, as per American Society of Clinical Oncology guidelines
- ctDNA screening phase: Available tumour sample from resected or biopsied tissue, with a tumour content of ≥20% (30% preferred) either before or after macro dissection (if performed) and a cell viability of a minimum 100 cells.
- ctDNA screening phase: Written informed consent must be given according to ICH/GCP, and national/local regulations.
- Randomised trial: ctDNA positive according to the Signatera ctDNA assay (main study ctDNA test) or other ctDNA assay approved for diagnostic purposes.
- Randomised trial: Patients must receive adjuvant ET at the time of the ctDNA positive test
- ctDNA screening phase: Invasive multicentric / multifocal disease is allowed provided that all the tested foci are ER+ HER2-. A sample from the highest-risk one, according to the investigator decision based on the size and grade, should be sent to Natera to build the patient ctDNA assay.
- Randomised trial: Patients must meet the eligibility criteria for the screening phase, with the exception of the tissue sample requirements.
- Randomised trial: Absence of locoregional and/or metastatic disease and/or new malignancy, as investigated by: Mammogram (unilateral in case of mastectomy; not required in patients having undergone bilateral mastectomy); CT thorax and abdomen/pelvis with IV contrast. In case of any contra-indications (medical or regulatory): CT thorax without contrast + MRI abdomen/pelvis; Technetium-99m bone scintigraphy
- Randomised trial: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
- Randomised trial: Adequate organ function
- Randomised trial: Women of childbearing potential (WOCBP) must have a negative highly sensitive serum or urine pregnancy test within 7 days prior to randomisation.
- ctDNA screening phase: Intermediate to high risk of recurrence after definitive treatment for early breast cancer
- ctDNA screening phase: Age ≥18 years
- ctDNA screening phase: Patients must have received at least 1 year and up to 7.5 years of ET and planned to continue adjuvant ET during ctDNA screening phase
- ctDNA screening phase: Previous neoadjuvant or adjuvant CDK4/6 inhibitor or PARP-inhibitor treatment is allowed provided it is completed
What rules you out
- ctDNA screening phase: Suspected recurrent disease or known conflicts with the inclusion and exclusion criteria for the randomised trial
- Randomised trial: Uncontrolled significant active infections (≥ grade 3 according to CTCAE version 5), including active hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency Virus (HIV)
- Randomised trial: Coagulopathy or any history of coagulopathy within the past 6 months, including history of deep vein thrombosis or pulmonary embolism
- ctDNA screening phase: Prior treatment with any SERD or investigational ER antagonist
- ctDNA screening phase: Previous history of invasive breast cancer
- ctDNA screening phase: Previous history of any other malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
- ctDNA screening phase: Bilateral invasive breast cancer
- Randomised trial: CTCAE version 5.0 grade 3 or 4 dyslipidemia at the time of screening, defined as cholesterol>400 mg/dL or >10.34 mmol/L and/or triglycerides >500 mg/dL or >5.7 mmol/L.
- ctDNA screening phase: Participation in another clinical study, with the exception of the SURVIVE study and observational (non-interventional) and non-drug intervention clinical studies. Note: patients participating in interventional studies may participate once they enter the follow-up period of the study
- Randomised trial: Any unresolved toxic effect of prior therapies or surgical procedures of Grade ≥ 2 according to Common Terminology Criteria of Adverse Events (CTCAE) v5.0, with the exception of alopecia, peripheral neuropathy and other toxicities not considered a safety risk for the participant at investigator’s discretion
- Randomised trial: Unable or unwilling to avoid over-the-counter medications, dietary/herbal supplements, and/or foods that are moderate/strong inhibitors or inducers of CYP3A4 activity
- Randomised trial: Known difficulty in tolerating oral medications or conditions which would impair absorption of oral medications
- ctDNA screening phase: Previous history of bone marrow and/or organ transplant
- ctDNA screening phase: Blood transfusion within 3 months prior to registration or during the screening
- Randomised trial: Any of the following cardiovascular disorders within 3 months before enrolment: myocardial infarction; stroke; severe/unstable angina; symptomatic cardiac arrhythmia; prolonged QTcF ≥ Grade 3 (i.e., > 500 msec); heart failure ≥ Class III as defined by the New York Heart Association (NYHA) guidelines
- Randomised trial: Child-Pugh Score greater than Class A
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.