Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer
NCT ID: NCT05386108
Last Updated: 2026-01-08
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE1/PHASE2
Total Enrollment
73 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-08-31
Study Completion Date
2026-12-31
Brief Summary
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This is a multi-site, global, open-label study that includes a phase 1b evaluation of elacestrant in combination with abemaciclib in women and men with brain metastases from estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER-2) negative breast cancer. Phase 1b was designed to select the recommended phase 2 dose (RP2D) and is followed by an ongoing phase 2 evaluation of elacestrant in combination with abemaciclib in participants with active brain metastases from ER-positive, HER-2 negative breast cancer.
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Detailed Description
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Conditions
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Breast Neoplasms
Brain Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Central Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
SEQUENTIAL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Phase 1b Cohort 1
Elacestrant 300 milligrams (mg) once daily (QD) + abemaciclib 100 mg twice daily (BID)
Group Type
EXPERIMENTAL
Elacestrant
Intervention Type
DRUG
300 mg, 400 mg
Abemaciclib
Intervention Type
DRUG
100 mg, 150 mg
Phase 1b Cohort 2
Elacestrant 400 mg QD + abemaciclib 100 mg BID
Group Type
EXPERIMENTAL
Elacestrant
Intervention Type
DRUG
300 mg, 400 mg
Abemaciclib
Intervention Type
DRUG
100 mg, 150 mg
Phase 1b Cohort 3
Elacestrant 400 mg QD + abemaciclib 150 mg BID
Group Type
EXPERIMENTAL
Elacestrant
Intervention Type
DRUG
300 mg, 400 mg
Abemaciclib
Intervention Type
DRUG
100 mg, 150 mg
Phase 2
Elacestrant in combination with abemaciclib at the RP2D determined in Phase 1b
Group Type
EXPERIMENTAL
Elacestrant
Intervention Type
DRUG
300 mg, 400 mg
Abemaciclib
Intervention Type
DRUG
100 mg, 150 mg
Interventions
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Elacestrant
300 mg, 400 mg
Intervention Type
DRUG
Abemaciclib
100 mg, 150 mg
Intervention Type
DRUG
Other Intervention Names
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Elacestrant dihydrochloride
RAD-1901
ER-306323
Orserdu
Verzenio
Eligibility Criteria
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Inclusion Criteria
1. Participant has the signed informed consent form before any study-related activities according to local guidelines.
2. Women or men aged ≥18 years, at the time of informed consent signature.
* Female participants may be either postmenopausal or pre/perimenopausal. Postmenopausal status is defined by:
1. Age ≥60 years
2. Age \<60 years and amenorrhea for 12 or more months without an alternative cause) and follicle stimulating hormone and estradiol in postmenopausal ranges per local reference ranges
3. Documentation of prior bilateral oophorectomy, at least 1 month before first dose of trial therapy).
* Pre-menopausal / peri-menopausal women and men must be concurrently receiving a luteinizing hormone-releasing hormone (LHRH) agonist starting at least 3-4 weeks before the start of trial therapy and is planning to continue LHRH during the study.
3. Participant must have ER-positive, HER-2 negative tumor status as confirmed by local laboratory testing in the following manner:
* Documentation of ER positive tumor with ≥ 1% staining by immunohistochemistry (IHC) as defined in the 2010 or 2020 American Society for Clinical Oncology (ASCO) recommendations for ER testing, with or without progesterone receptor (PGR) positivity
* HER-2 negative tumor with an IHC result of 0 or 1+ for cellular membrane protein expression or an in situ hybridization negative result as defined in the 2013 or 2018 ASCO recommendations for HER-2 testing
4. In Phase 2, participants must have at least one active and measurable brain metastasis per RECIST version 1.1.
* Any of the following qualifies brain metastases as active:
1. Newly diagnosed brain metastasis in participants who never received prior central nervous system (CNS)-directed therapy.
2. Newly diagnosed brain metastasis outside any area that was previously subjected to CNS-directed therapy.
3. Brain metastases demonstrating unequivocal progression in the opinion of the treating investigator in an area that has previously been subjected to CNS-directed therapy.
* For lesions, including brain metastases, to qualify as measurable, and possibly be selected as target lesions, per RECIST version 1.1, the longest diameter must be ≥10 millimeters \[mm\] by computed tomography \[CT\] or magnetic resonance imaging \[MRI\]).
* In Phase 1b, the presence of brain metastases is allowed but not required for eligibility, in this case, at least 1 measurable lesion outside the brain is required.
5. Participants receiving concomitant corticosteroids must be on a stable or decreasing dose for at least 7 days prior to baseline and not receiving doses higher than 4 mg of dexamethasone per day or equivalent.
6. Participants have experienced no more than one seizure within 4 weeks prior to starting trial therapy.
7. Participants' prior therapy received in the metastatic setting includes:
* At least one endocrine therapy
* Up to two chemotherapy regimens
* Up to two lines of prior cyclin-dependent kinase (CDK) 4/6 inhibitor, not including abemaciclib
Note 1: Toxicity from prior therapy must be resolved to NCI CTCAE version 5.0 Grade ≤1, with the exception of alopecia and peripheral sensory neuropathy (Grade ≤2).
Note 2: Chemotherapy refers to not targeted cytotoxic agents (for example, alkylating agents, taxanes, nucleotide analogs, platinum-based drugs, vinca alkaloids, etc) and antibody drug conjugates (ADCs). Targeted therapies (for example, kinase inhibitors) are not considered chemotherapy for eligibility purposes. Not targeted cytotoxic agents administered for less than 1 cycle will not be counted as a prior chemotherapy regimen.
8. Participant has documented intracranial and/or extracranial radiological progression or recurrence while on or after the most recent therapy.
9. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
10. Participant has a life expectancy ≥ 12 weeks.
11. Participant has adequate bone marrow and organ function, as defined by the following laboratory values:
1. Absolute neutrophil count (ANC) ≥1.5 × 10\^9/liter (L)
2. Platelets ≥100 × 10\^9/L
3. Hemoglobin ≥9.0 grams (g)/deciliter (dL)
4. Potassium, sodium, calcium (corrected for serum albumin) and magnesium CTCAE Grade ≤1 (if screening assessments are abnormal, these assessments may be repeated up to 2 times; participants may receive appropriate supplementation or treatment prior to reassessment)
5. Creatinine clearance (per Cockcroft-Gault formula) ≥50 mL/minute
6. Serum albumin ≥3.0 g/dL (≥30 g/L)
7. Liver function tests:
In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 × upper limit of normal (ULN). If the participant has liver metastases, ALT and AST ≤5.0 × ULN.
8. Total serum bilirubin \<1.5 × ULN except for participants with Gilbert's syndrome who may be included if the total serum bilirubin is ≤3.0 × ULN or direct bilirubin ≤ 1.5 × ULN
12. The participant is willing and able to adhere to the study visit schedule and other protocol requirements.
2. Women or men aged ≥18 years, at the time of informed consent signature.
* Female participants may be either postmenopausal or pre/perimenopausal. Postmenopausal status is defined by:
1. Age ≥60 years
2. Age \<60 years and amenorrhea for 12 or more months without an alternative cause) and follicle stimulating hormone and estradiol in postmenopausal ranges per local reference ranges
3. Documentation of prior bilateral oophorectomy, at least 1 month before first dose of trial therapy).
* Pre-menopausal / peri-menopausal women and men must be concurrently receiving a luteinizing hormone-releasing hormone (LHRH) agonist starting at least 3-4 weeks before the start of trial therapy and is planning to continue LHRH during the study.
3. Participant must have ER-positive, HER-2 negative tumor status as confirmed by local laboratory testing in the following manner:
* Documentation of ER positive tumor with ≥ 1% staining by immunohistochemistry (IHC) as defined in the 2010 or 2020 American Society for Clinical Oncology (ASCO) recommendations for ER testing, with or without progesterone receptor (PGR) positivity
* HER-2 negative tumor with an IHC result of 0 or 1+ for cellular membrane protein expression or an in situ hybridization negative result as defined in the 2013 or 2018 ASCO recommendations for HER-2 testing
4. In Phase 2, participants must have at least one active and measurable brain metastasis per RECIST version 1.1.
* Any of the following qualifies brain metastases as active:
1. Newly diagnosed brain metastasis in participants who never received prior central nervous system (CNS)-directed therapy.
2. Newly diagnosed brain metastasis outside any area that was previously subjected to CNS-directed therapy.
3. Brain metastases demonstrating unequivocal progression in the opinion of the treating investigator in an area that has previously been subjected to CNS-directed therapy.
* For lesions, including brain metastases, to qualify as measurable, and possibly be selected as target lesions, per RECIST version 1.1, the longest diameter must be ≥10 millimeters \[mm\] by computed tomography \[CT\] or magnetic resonance imaging \[MRI\]).
* In Phase 1b, the presence of brain metastases is allowed but not required for eligibility, in this case, at least 1 measurable lesion outside the brain is required.
5. Participants receiving concomitant corticosteroids must be on a stable or decreasing dose for at least 7 days prior to baseline and not receiving doses higher than 4 mg of dexamethasone per day or equivalent.
6. Participants have experienced no more than one seizure within 4 weeks prior to starting trial therapy.
7. Participants' prior therapy received in the metastatic setting includes:
* At least one endocrine therapy
* Up to two chemotherapy regimens
* Up to two lines of prior cyclin-dependent kinase (CDK) 4/6 inhibitor, not including abemaciclib
Note 1: Toxicity from prior therapy must be resolved to NCI CTCAE version 5.0 Grade ≤1, with the exception of alopecia and peripheral sensory neuropathy (Grade ≤2).
Note 2: Chemotherapy refers to not targeted cytotoxic agents (for example, alkylating agents, taxanes, nucleotide analogs, platinum-based drugs, vinca alkaloids, etc) and antibody drug conjugates (ADCs). Targeted therapies (for example, kinase inhibitors) are not considered chemotherapy for eligibility purposes. Not targeted cytotoxic agents administered for less than 1 cycle will not be counted as a prior chemotherapy regimen.
8. Participant has documented intracranial and/or extracranial radiological progression or recurrence while on or after the most recent therapy.
9. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
10. Participant has a life expectancy ≥ 12 weeks.
11. Participant has adequate bone marrow and organ function, as defined by the following laboratory values:
1. Absolute neutrophil count (ANC) ≥1.5 × 10\^9/liter (L)
2. Platelets ≥100 × 10\^9/L
3. Hemoglobin ≥9.0 grams (g)/deciliter (dL)
4. Potassium, sodium, calcium (corrected for serum albumin) and magnesium CTCAE Grade ≤1 (if screening assessments are abnormal, these assessments may be repeated up to 2 times; participants may receive appropriate supplementation or treatment prior to reassessment)
5. Creatinine clearance (per Cockcroft-Gault formula) ≥50 mL/minute
6. Serum albumin ≥3.0 g/dL (≥30 g/L)
7. Liver function tests:
In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 × upper limit of normal (ULN). If the participant has liver metastases, ALT and AST ≤5.0 × ULN.
8. Total serum bilirubin \<1.5 × ULN except for participants with Gilbert's syndrome who may be included if the total serum bilirubin is ≤3.0 × ULN or direct bilirubin ≤ 1.5 × ULN
12. The participant is willing and able to adhere to the study visit schedule and other protocol requirements.
Exclusion Criteria
1. Immediate CNS-specific treatment is likely to be required, per the treating physician's assessment.
2. Participant has imminent organ failure and/or visceral crisis.
3. Participant has leptomeningeal metastases, defined as having positive cerebrospinal fluid (CSF) cytology or unequivocal radiologic and clinical evidence of leptomeningeal involvement. Note: Discrete dural metastases are permitted.
4. Breast cancer treatment-naïve participants (that is, not having received any systemic therapy) in the advanced/metastatic setting.
5. History of pulmonary embolism (PE), cardiovascular accident (CVA), myocardial infarction (MI) in the past 6 months from screening visit.
6. Prior therapy with abemaciclib in the metastatic setting. Note: Use of abemaciclib in the adjuvant setting is allowed if the last treatment administration was more than 12 months prior to first recurrence.
7. Prior therapy with elacestrant or other investigational selective estrogen receptor degraders (SERDs), or investigational alike agents such as selective estrogen receptor modulators (SERMs), selective estrogen receptor covalent antagonists (SERCANs), complete estrogen receptor antagonists (CERANs), and proteolysistargeting chimeras (PROTACs) in the metastatic setting.
8. Participant has a concurrent malignancy or malignancy within 3 years of enrollment, with the exception of adequately treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, or second primary breast cancer; and any other malignancy that is considered in complete remission by the Investigator(s) that is approved by the Medical Monitor.
9. Currently participating in another breast cancer intervention clinical study. Participants who are being followed for overall survival for another clinical trial with no therapy and study intervention are allowed after the washout period for any prior therapy.
10. Prior anti-cancer or investigational drug treatment within the following windows:
* Fulvestrant treatment (last injection) \<42 days before first dose of study drug
* Any other endocrine therapy \<14 days before first dose of study drug. Note: LHRH agonists should not be counted as endocrine therapy.
* Chemotherapy or other anti-cancer therapy \<14 days before first dose of study drug
* Any investigational anti-cancer drug therapy within \<28 days or \<5 half lives, whichever is shorter
* Bisphosphonates or receptor activator of nuclear factor-κB ligand (RANKL) inhibitors initiated, or dose changed \<1 month prior to first dose of study drug according to institutional guidelines.
11. Radiation therapy (including CNS directed) within 7 days before the first dose of study drug or without a full recovery from radiotherapy acute effects.
12. Uncontrolled significant active infections
* Participants with hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection must have undetectable viral load (or detected below the lower limit of quantification) during screening
* Participants known to be human immunodeficiency virus positive (HIV+) are allowed as long as they have undetectable viral load (viral suppression) at baseline.
13. Major surgery within 4 weeks of starting trial therapy.
14. Inability to take oral medication, or history of malabsorption syndrome or any other uncontrolled gastrointestinal condition that may significantly alter the absorption of study drugs.
15. Females of childbearing potential who do not agree to use a highly effective non-hormonal method of contraception and to abstain from donating ova within 28 days of the first dose of study treatment through 120 days after the last dose of study treatment. Highly effective non-hormonal method of contraception includes any of the following:
1. Intrauterine device (non-hormonal)
2. Sexual abstinence
3. Bilateral tubal occlusion/ligation
4. Have a vasectomized partner with confirmed azoospermia.
16. Male participants (including males after a vasectomy) with a pregnant or non-pregnant female of childbearing potential partner who do not agree to use a highly effective barrier contraception method (condoms) within 28 days of the first dose of study treatment until 120 days of the last dose of study treatment. And male participants who do not agree to abstain from freezing or donating sperm within the same period. In addition, female partners of childbearing potential, of male participants (who has not undergone vasectomy) must use highly effective methods of contraception.
17. Females who are pregnant or breastfeeding. Females should not get pregnant during study treatment and for 120 days after last dose of study treatment. Females should not breastfeed during administration of elacestrant and for 1 week after receiving the last dose.
18. Known intolerance to either study drug or any of their excipients.
19. Participants currently receiving or received any of the following medications prior to first dose of trial therapy:
1. Known strong or moderate inducers or inhibitors of cytochrome P450 (CYP) 3A4 (including foods and herbal preparations) within 14 days or \<5 half-lives, whichever is shorter)
2. Herbal preparations/medications (which are not strong or moderate inducers or inhibitors of CYP3A4). These include, but are not limited to, kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng within 7 days prior to initiating trial therapy
3. Vaccination, including but not limited to vaccination against coronavirus disease-19 (COVID-19), during the 7 days prior to randomization.
20. Any severe medical or psychiatric condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study.
2. Participant has imminent organ failure and/or visceral crisis.
3. Participant has leptomeningeal metastases, defined as having positive cerebrospinal fluid (CSF) cytology or unequivocal radiologic and clinical evidence of leptomeningeal involvement. Note: Discrete dural metastases are permitted.
4. Breast cancer treatment-naïve participants (that is, not having received any systemic therapy) in the advanced/metastatic setting.
5. History of pulmonary embolism (PE), cardiovascular accident (CVA), myocardial infarction (MI) in the past 6 months from screening visit.
6. Prior therapy with abemaciclib in the metastatic setting. Note: Use of abemaciclib in the adjuvant setting is allowed if the last treatment administration was more than 12 months prior to first recurrence.
7. Prior therapy with elacestrant or other investigational selective estrogen receptor degraders (SERDs), or investigational alike agents such as selective estrogen receptor modulators (SERMs), selective estrogen receptor covalent antagonists (SERCANs), complete estrogen receptor antagonists (CERANs), and proteolysistargeting chimeras (PROTACs) in the metastatic setting.
8. Participant has a concurrent malignancy or malignancy within 3 years of enrollment, with the exception of adequately treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, or second primary breast cancer; and any other malignancy that is considered in complete remission by the Investigator(s) that is approved by the Medical Monitor.
9. Currently participating in another breast cancer intervention clinical study. Participants who are being followed for overall survival for another clinical trial with no therapy and study intervention are allowed after the washout period for any prior therapy.
10. Prior anti-cancer or investigational drug treatment within the following windows:
* Fulvestrant treatment (last injection) \<42 days before first dose of study drug
* Any other endocrine therapy \<14 days before first dose of study drug. Note: LHRH agonists should not be counted as endocrine therapy.
* Chemotherapy or other anti-cancer therapy \<14 days before first dose of study drug
* Any investigational anti-cancer drug therapy within \<28 days or \<5 half lives, whichever is shorter
* Bisphosphonates or receptor activator of nuclear factor-κB ligand (RANKL) inhibitors initiated, or dose changed \<1 month prior to first dose of study drug according to institutional guidelines.
11. Radiation therapy (including CNS directed) within 7 days before the first dose of study drug or without a full recovery from radiotherapy acute effects.
12. Uncontrolled significant active infections
* Participants with hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection must have undetectable viral load (or detected below the lower limit of quantification) during screening
* Participants known to be human immunodeficiency virus positive (HIV+) are allowed as long as they have undetectable viral load (viral suppression) at baseline.
13. Major surgery within 4 weeks of starting trial therapy.
14. Inability to take oral medication, or history of malabsorption syndrome or any other uncontrolled gastrointestinal condition that may significantly alter the absorption of study drugs.
15. Females of childbearing potential who do not agree to use a highly effective non-hormonal method of contraception and to abstain from donating ova within 28 days of the first dose of study treatment through 120 days after the last dose of study treatment. Highly effective non-hormonal method of contraception includes any of the following:
1. Intrauterine device (non-hormonal)
2. Sexual abstinence
3. Bilateral tubal occlusion/ligation
4. Have a vasectomized partner with confirmed azoospermia.
16. Male participants (including males after a vasectomy) with a pregnant or non-pregnant female of childbearing potential partner who do not agree to use a highly effective barrier contraception method (condoms) within 28 days of the first dose of study treatment until 120 days of the last dose of study treatment. And male participants who do not agree to abstain from freezing or donating sperm within the same period. In addition, female partners of childbearing potential, of male participants (who has not undergone vasectomy) must use highly effective methods of contraception.
17. Females who are pregnant or breastfeeding. Females should not get pregnant during study treatment and for 120 days after last dose of study treatment. Females should not breastfeed during administration of elacestrant and for 1 week after receiving the last dose.
18. Known intolerance to either study drug or any of their excipients.
19. Participants currently receiving or received any of the following medications prior to first dose of trial therapy:
1. Known strong or moderate inducers or inhibitors of cytochrome P450 (CYP) 3A4 (including foods and herbal preparations) within 14 days or \<5 half-lives, whichever is shorter)
2. Herbal preparations/medications (which are not strong or moderate inducers or inhibitors of CYP3A4). These include, but are not limited to, kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng within 7 days prior to initiating trial therapy
3. Vaccination, including but not limited to vaccination against coronavirus disease-19 (COVID-19), during the 7 days prior to randomization.
20. Any severe medical or psychiatric condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Stemline Therapeutics, Inc.
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Providence Medical Foundation
Fullerton, California, United States
Site Status
RECRUITING
California Research Institute
Los Angeles, California, United States
Site Status
RECRUITING
Carle Cancer Center
Urbana, Illinois, United States
Site Status
RECRUITING
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Site Status
RECRUITING
Henry Ford Hospital
Detroit, Michigan, United States
Site Status
RECRUITING
Miami Valley Hospital South
Centerville, Ohio, United States
Site Status
RECRUITING
Oregon Health & Science University
Portland, Oregon, United States
Site Status
COMPLETED
SCRI Oncology Partners
Nashville, Tennessee, United States
Site Status
RECRUITING
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Site Status
RECRUITING
UT Health San Antonio University of Texas
San Antonio, Texas, United States
Site Status
RECRUITING
Virginia Cancer Institute
Norfolk, Virginia, United States
Site Status
RECRUITING
Antwerp University Hospital
Edegem, , Belgium
Site Status
RECRUITING
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, , Belgium
Site Status
RECRUITING
Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, , Belgium
Site Status
RECRUITING
Institut de Cancerologie de l'Ouest site Paul Papin
Angers, , France
Site Status
RECRUITING
Hôpital Morvan - CHRU de Brest - cancérologie et d'hématologie
Brest, , France
Site Status
RECRUITING
Centre Francois Baclesse - Oncologie Medicale - Cancerolo
Caen, , France
Site Status
RECRUITING
Centre Jean Perrin
Clermont-Ferrand, , France
Site Status
RECRUITING
Centre Léon Bérard - Département Oncologie Médicale
Lyon, , France
Site Status
RECRUITING
Centre de Cancerologie du Grand Montpellier
Montpellier, , France
Site Status
RECRUITING
Hôpital de la Pitiê Salpêtriêre
Paris, , France
Site Status
RECRUITING
Centre Hospitalier Universitaire de Poitiers
Poitiers, , France
Site Status
RECRUITING
Institut Claudius Regaud
Toulouse, , France
Site Status
RECRUITING
Klinikum Bayreuth GmbH
Bayreuth, , Germany
Site Status
RECRUITING
Uniklinik Koeln - Klinik und Poliklinik fuer Frauenheilkunde
Cologne, , Germany
Site Status
COMPLETED
Universitatsklinikum Carl Gustav Carus
Dresden, , Germany
Site Status
RECRUITING
Universitaetsklinikum Duesseldorf
Düsseldorf, , Germany
Site Status
RECRUITING
Universitätsklinikum Erlangen
Erlangen, , Germany
Site Status
RECRUITING
Medizinische Hochschule Hannover
Hanover, , Germany
Site Status
RECRUITING
Universitätsklinikum Leipzig
Leipzig, , Germany
Site Status
RECRUITING
Klinikum Worms gGmbH
Worms, , Germany
Site Status
RECRUITING
Helios Klinikum Wuppertal
Wuppertal, , Germany
Site Status
RECRUITING
National and Capodistrian University of Athens - University General Hospital Attikon
Athens, , Greece
Site Status
RECRUITING
Metropolitan Hospital [Oncology]
Piraeus, , Greece
Site Status
RECRUITING
EUROMEDICA General Clinic of Thessaloniki
Thessaloniki, , Greece
Site Status
COMPLETED
Interbalkan European Medical Center
Thessaloniki, , Greece
Site Status
RECRUITING
AOU Ospedali Riuniti Umberto I-G.M.Lancisi -G.Salesi
Ancona, , Italy
Site Status
RECRUITING
Istituto di Candiolo, IRCCS
Candiolo, , Italy
Site Status
RECRUITING
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST IRCCS
Meldola, , Italy
Site Status
RECRUITING
A. O. Ospedali Riuniti Parpardo, Piemonte, Messina
Messina, , Italy
Site Status
RECRUITING
IEO - Istituto Europeo di Oncologia, IRCCS
Milan, , Italy
Site Status
RECRUITING
Azienda Ospedaliero-Universitaria di Modena, Policlinico di Modena
Modena, , Italy
Site Status
RECRUITING
Ospedale San Gerardo, ASST di Monza, IRCCS
Monza, , Italy
Site Status
RECRUITING
Azienda Ospedaliera Universitaria Federico II
Napoli, , Italy
Site Status
RECRUITING
Istituto Nazionale dei Tumori - Fondazione Pascale, IRCCS
Napoli, , Italy
Site Status
RECRUITING
Istituto Oncologico Veneto IOV - IRCCS
Padua, , Italy
Site Status
RECRUITING
IRCCS Policlinico San Matteo, Università degli studi di Pavia, Pavia Fondazione IRCCS Policlinico San Matteo
Pavia, , Italy
Site Status
RECRUITING
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, , Italy
Site Status
RECRUITING
Azienda Ospedaliera Santa Maria di Terni
Terni, , Italy
Site Status
RECRUITING
AOU Città della Salute e della Scienza di Torino, Ospedale Molinette
Torino, , Italy
Site Status
RECRUITING
Asan Medical Center
Seoul, , South Korea
Site Status
RECRUITING
Gangnam Severance Hospital
Seoul, , South Korea
Site Status
RECRUITING
Samsung Medical Center
Seoul, , South Korea
Site Status
RECRUITING
Ewha Womans University MokDong Hospital
Seoul, , South Korea
Site Status
RECRUITING
Seoul National University Bundang Hospital
Seoul, , South Korea
Site Status
RECRUITING
Seoul National University Hospital
Seoul, , South Korea
Site Status
RECRUITING
University Hospital Reina Sofía
Córdoba, Andalusia, Spain
Site Status
RECRUITING
University Hospital Ramón y Cajal
Madrid, Madrid, Spain
Site Status
RECRUITING
University Hospital 12 de Octubre
Madrid, Madrid, Spain
Site Status
RECRUITING
Clara Campal Comprehensive Cancer Center (CIOCC)
Madrid, Madrid, Spain
Site Status
RECRUITING
University Clinical Hospital Virgen de la Arrixaca
El Palmar, Murcia, Spain
Site Status
RECRUITING
Hospital Clinic De Barcelona
Barcelona, , Spain
Site Status
RECRUITING
Hospital Universitari Vall D Hebron
Barcelona, , Spain
Site Status
RECRUITING
Clinica Universidad de Navarra
Madrid, , Spain
Site Status
RECRUITING
Hospital Clínico San Carlos
Madrid, , Spain
Site Status
RECRUITING
Hospital Universitario Quirónsalud Madrid
Madrid, , Spain
Site Status
RECRUITING
Clinica Universidad de Navarra
Pamplona, , Spain
Site Status
RECRUITING
Complexo Hospitalario Universitario De Santiago
Santiago de Compostela, , Spain
Site Status
RECRUITING
Fundación Instituto Valenciano De Oncología
Valencia, , Spain
Site Status
RECRUITING
Hospital Universitario Virgen del Rocío
Valencia, , Spain
Site Status
RECRUITING
Adana Sehir Hastanesi
Adana, , Turkey (Türkiye)
Site Status
RECRUITING
Ankara Bilkent Sehir Hastanesi Tibbi Onkoloji Klinigi
Ankara, , Turkey (Türkiye)
Site Status
RECRUITING
Ankara University Medical Faculty
Ankara, , Turkey (Türkiye)
Site Status
RECRUITING
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
Ankara, , Turkey (Türkiye)
Site Status
RECRUITING
Gulhane Egitim ve Arastirma Hastanesi Tibbi Onkoloji Klinigi
Ankara, , Turkey (Türkiye)
Site Status
RECRUITING
Hacettepe University Medical Faculty
Ankara, , Turkey (Türkiye)
Site Status
RECRUITING
Memorial Ankara Hastanesi Tibbi Onkoloji
Ankara, , Turkey (Türkiye)
Site Status
RECRUITING
Ege University Medical Faculty
Bornova, , Turkey (Türkiye)
Site Status
RECRUITING
Acibadem Altunizade Hospital
Istanbul, , Turkey (Türkiye)
Site Status
RECRUITING
Medipol Mega Hospital - Medical Oncology
Istanbul, , Turkey (Türkiye)
Site Status
RECRUITING
Prof. Dr. Suleyman Yalcin Sehir Hastanesi
Istanbul, , Turkey (Türkiye)
Site Status
RECRUITING
University Hospitals of Leicester NHS Trust -Glenfield Hospital
Leicester, , United Kingdom
Site Status
WITHDRAWN
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, , United Kingdom
Site Status
WITHDRAWN
Guy's and St Thomas' NHS Foundation Trust
London, , United Kingdom
Site Status
RECRUITING
University College London Hospitals NHS Foundation Trust - University College Hospital (UCH) - Macmillan Cancer Centre
London, , United Kingdom
Site Status
RECRUITING
The Christie NHS Foundation Trust - Medical Oncology
Manchester, , United Kingdom
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
United States
Belgium
France
Germany
Greece
Italy
South Korea
Spain
Turkey (Türkiye)
United Kingdom
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Role: backup
44 161 918 2352
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-512878-98-00
Identifier Type: CTIS
Identifier Source: secondary_id
ELA-0121
Identifier Type: -
Identifier Source: org_study_id
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