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Evaluating the Addition of Elacestrant (Oral SERD) to Olaparib (PARP-inhibitor) in Patients With Advanced/Metastatic HR+/HER2- Breast Cancer

Study acronym: ELEMENT
StatusRecruiting
PhasePhase 2
Started2024-12-13
View on ClinicalTrials.gov ↗

Amendment history

2025-11-24
Study Identification, Study Status, Oversight, Contacts/Locations v5
Study sites2→36
Study titlerevised
Evaluating the Addition of Elacestrant (oralOral SERD) to Olaparib (PARP-inhibitor) in Patients withWith Advanced/metastaticMetastatic HR+/HER2- Breast Cancer
2024-12-16
Study Status, Contacts/Locations v4
Start dateestimated 2024-11→confirmed 2024-12-13
Study sitesdetails revised at 2 of 2 sites
2024-11-13
Study Status, Eligibility, Contacts/Locations v3
Study sites1→2
Eligibility criteria-36 characters
[...] or male patients. Age at study entry of at least 18 years. Centrally confirmed locallyLocally advanced or metastatic breast cancer that is HR-positive (E [...] Patients with deleterious or suspected deleterious gBRCA1/2 mutation detected upon local testing. Willingness and ability to prov [...] study, required contraception timelines for female and male patientpatients afterare thedescribed end of therapy differ (refer toin the study protocol). Any of the following within 6 months prior to enrolment: m [...]
2024-11-05
Study Identification, Study Status, Oversight, References v2
Start date2024-10-02→2024-11
Publications4 entries, reordered
Study titlerevised
Evaluating the Addition of Elacestrant (Oraloral SERD) to Olaparib (PARP-inhibitor) in Patients Withwith Advanced/Metastaticmetastatic HR+/HER2- Breast Cancer
2024-10-09
Not Yet Recruiting→Recruiting Study Identification, Study Status, Sponsor/Collaborators, Study Description, Conditions, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing, References v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2028-03-31→2028-12-31
Completion date2028-03-31→2028-12-31
Start date2024-03-31→2024-10-02
InterventionsNiraparib (Drug), Niraparib + Elacestrant (Drug)→Olaparib (Drug), Olaparib + Elacestrant (Drug)
Eligibility criteria-880 characters
[...] elines). Patients with deleterious or suspected deleterious g/tBRCA1gBRCA1/2 and/or g/tPALB2 mutations, detected upon local testing. Willingness and ability to pro [...] block or a partial block from archived tumor or metastasis. PatientsIndication whofor receivedstandard-of-care atPARP least one prior line of chemotherapy or endocrine-basedinhibitor therapy forand irresectable, locally advanced, or metastatic disease, or patients with recurrent, unresectable, locally advanced, or metastatic disease after adjuvantplanned treatment with CDK4/6 inhibitor therapyolaparib. Eastern Cooperative Oncology Gr [...] [...]
Secondary endpointsdetails revised at 1 of 10 entries
Study description-181 characters
Patients with HR-positive, HER2-negative advanced or metastatic breast cancer and g/tBRCA1gBRCA1/2 and/or g/tPALB2 mutations have a low progression-free survival (PFS) and re [...] with disease progression following at least one line of ET. NiraparibOlaparib is aapproved poly-adenosineby diphosphatethe riboseEMA polymerasefor (PARP)deleterious inhibitoror thatsuspected has shown promise in patients withdeleterious gBRCA-mutated, HER2-negative locally advanced or metastatic breast cancerBC, previouslybased treatedon positive outcomes in the phase III OlympiAD trial which showed improved median PFS, re [...] [...]
Study sitesdetails revised at 1 of 1 site
Collaborators2 to 1 entries
GlaxoSmithKline
Publications7 to 4 entries
Litton JK, Rugo HS, Ettl J, Hurvitz SA, Goncalves A, Lee KH, Fehrenbacher L, Yerushalmi R, Mina LA, Martin M, Roche H, Im YH, Quek RGW, Markova D, Tudor IC, Hannah AL, Eiermann W, Blum JL. Talazoparib in Patients with Advanced Breast Cancer and a Germline BRCA Mutation. N Engl J Med. 2018 Aug 23;379 [...]
Study title-1 characters
Evaluating the Addition of Elacestrant (Oral SERD) to NiraparibOlaparib (PARP-inhibitor) in Patients With Advanced/Metastatic HR+/HER2- Breast Cancer
2023-12-29
Original filing
Trial design: Phase II, prospective, multi-center, randomized, open label, parallel group study in patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with gBRCA1/2 mutation, with 2:1 randomization into Arm A (olaparib + elacestrant) or arm B (olaparib). Treatment in either arm will be given until disease progression, unacceptable toxicity, withdrawal of patient´s consent to study participation, or end of study. Trial population: Patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with gBRCA1/2 mutation, with an indication for standard-of-care PARP inhibitor therapy and planned treatment with olaparib, an ECOG performance status of 0-2 and life expectancy of \> 6 months, with normal bone marrow and kidney functions and no active or newly diagnosed central nervous system (CNS) metastases or symptomatic metastatic visceral disease at risk of life-threatening complications. Interventions: Patients randomized to Arm A will receive 600 mg olaparib daily and 400 mg elacestrant daily, while patients randomized to Arm B will receive 600 mg olaparib daily. Blood tests (hematology, biochemistry) will be performed at the beginning of every cycle, and imaging for tumor assessment (chest and abdominopelvic imaging) as well as QoL assessments will be performed every three months and in case of suspicion of progression/end of study.
Trial Details
NCT Number NCT06201234
Lead Sponsor GBG Forschungs GmbH
Collaborators: Stemline Therapeutics, Inc.
Conditions Hormone Receptor Positive HER-2 Negative Breast Cancer, Advanced or Metastatic Breast Cancer, BRCA1 Mutation, BRCA2 Mutation
Enrollment 176 participants
Start Date 2024-12-13
Primary Completion 2028-12-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-12-01