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
- Conditions
- Breast cancerMedDRA version: 23.0Level: PTClassification code: 10083232Term: HER2 negative breast cancer Class: 100000004864MedDRA version: 23.0Level: PTClassification code: 10083234Term: Hormone receptor positive breast cancer Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2022-501453-36-00
- Lead Sponsor
- European Organisation For Research And Treatment Of Cancer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 215
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; 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, Randomised trial: Absence of locoregional and/or metastatic disease, 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 3 days prior to randomisation., ctDNA screening phase: Elevated risk of recurrence after definitive treatment for early breast cancer, defined as: EITHER: Stage IIB or stage III disease according to the 8th edition of the UICC TNM classification and completion of adjuvant chemotherapy. OR: Completion of at least 4 cycles of neoadjuvant chemotherapy and residual tumour at surgery of = 1cm (=ypT1c) or axillary node + (ypN+), ctDNA screening phase: Age =18 years, ctDNA screening phase: Patients must have received at least 4.5 years and up to 7 years of ET and planned to continue adjuvant ET during ctDNA screening phase, ctDNA screening phase: Previous adjuvant CDK4/6 inhibitor or PARP-inhibitor treatment is allowed, ctDNA screening phase: Available FFPE tumour block with 25mm2 minimum surface from the baseline biopsy or from surgical specimen OR preferably 6-10 unstained slides of 10µm each (or 12-20 unstained slides at 5µm each) PLUS one H&E slide. Tumour cellularity must be = 20% (preferably =30%)., 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, Randomised trial: Patients must receive adjuvant ET at the time of the ctDNA positive test
ctDNA screening phase: Suspected recurrent disease or known conflicts with the inclusion and exclusion criteria for the randomised trial, 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, 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. Patients who have been disease free for more than 5 years with low risk of relapse are allowed, ctDNA screening phase: Bilateral breast cancer, ctDNA screening phase: Participation in another clinical study, with the exception of the SURVIVE study and observational (non-interventional) 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 prescription medications, 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method