Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer

NCT ID: NCT05563220

Last Updated: 2026-01-06

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

435 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-24

Study Completion Date

2028-12-28

Brief Summary

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This is a multicenter, Phase 1b/2 trial in participants with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) advanced/metastatic breast cancer. The phase 1b part of the trial will determine the recommended Phase 2 dose (RP2D) of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, capivasertib, and ribociclib. The Phase 2 part of the trial will evaluate the efficacy and safety of the various combinations.

Detailed Description

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This is a multicenter, Phase 1b/2 trial. The Phase 1b aims at selecting the RP2D dose, defined as a dose that is associated with less than 33% of participants experiencing a dose-limiting toxicity (DLT) of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, ribociclib, and capivasertib that is, ≤1 participant experiencing a DLT out of 6 DLT-evaluable participants. For each combination, this phase will have approximately 3 cohorts of up to 6 DLT-evaluable participants each. The total number of DLT-evaluable participants in all the combinations will be up to 125.

The Phase 2 part of the trial will evaluate the efficacy and safety of the various combinations.

The treatment arms will be:

* Arm A: 50 participants: elacestrant with alpelisib;
* Arm B: 50 participants: elacestrant with everolimus;
* Arm C: 60 participants (30 participants in each combination): elacestrant with either abemaciclib or ribociclib;
* Arm D: 90 participants (30 participants in each combination): elacestrant with either palbociclib, abemaciclib, or ribociclib;
* Arm E: 60 participants: elacestrant with capivasertib

Phase 1b will have a total of 125 participants, while Phase 2 will have 310 participants for all treatment arm combinations.

Conditions

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Breast Cancer Metastatic Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase 1b Arm A: elacestrant with alpelisib

Elacestrant Dihydrochloride 300 milligrams (mg) or 400 mg + Alpelisib 150 mg to 250 mg

Group Type EXPERIMENTAL

Elacestrant

Intervention Type DRUG

Elacestrant 86 mg, 172 mg, 258 mg or 345 mg once daily in cycles of 28 days

Alpelisib

Intervention Type DRUG

Alpelisib 150 mg or 250 mg once daily in cycles of 28 days

Phase 1b Arm B: elacestrant with everolimus

Elacestrant Dihydrochloride 300 mg or 400 mg + Everolimus 5.0 mg, 7.5 mg or possibly 10 mg

Group Type EXPERIMENTAL

Elacestrant

Intervention Type DRUG

Elacestrant 86 mg, 172 mg, 258 mg or 345 mg once daily in cycles of 28 days

Everolimus

Intervention Type DRUG

Everolimus 5 mg, 7.5 mg, or 10 mg once daily in cycles of 28 days

Phase 1b Arm C: elacestrant with abemaciclib or ribociclib:

Elacestrant Dihydrochloride 100 mg, 200 mg, 300 mg + Ribociclib 400 mg or possibly 600 mg

The RP2D for the combination of elacestrant and abemaciclib is evaluated in the ongoing ELECTRA trial (ClinicalTrials.gov Identifier: NCT04791384)

Group Type EXPERIMENTAL

Elacestrant

Intervention Type DRUG

Elacestrant 86 mg, 172 mg, 258 mg or 345 mg once daily in cycles of 28 days

Ribociclib

Intervention Type DRUG

Ribociclib 400 mg or 600 mg once daily for 21 days followed by 7 days off in cycles of 28 days

Abemaciclib

Intervention Type DRUG

Abemaciclib 100 mg or 150 mg twice daily in cycles of 28 consecutive days

Phase 1b Arm D: elacestrant with either palbociclib, abemaciclib, or ribociclib (no prior CDK4/6i)

Elacestrant Dihydrochloride 300 mg or 400 mg + Palbociclib 100 mg,125 mg or the RP2D for the combination of elacestrant and abemaciclib is evaluated in the ongoing ELECTRA trial (ClinicalTrials.gov Identifier: NCT04791384)

Elacestrant 86 mg, 172 mg, 258 mg + Ribociclib 400 mg or possibly 600 mg

Group Type EXPERIMENTAL

Elacestrant

Intervention Type DRUG

Elacestrant 86 mg, 172 mg, 258 mg or 345 mg once daily in cycles of 28 days

Ribociclib

Intervention Type DRUG

Ribociclib 400 mg or 600 mg once daily for 21 days followed by 7 days off in cycles of 28 days

Palbociclib

Intervention Type DRUG

Palbociclib 100 mg or 125 mg once daily for 21 days followed by 7 days off in cycles of 28 days

Abemaciclib

Intervention Type DRUG

Abemaciclib 100 mg or 150 mg twice daily in cycles of 28 consecutive days

Phase 1b Arm E:

Elacestrant Dihydrochloride 300 mg, 400 mg + Capivasertib 200 mg, 320 mg, 400 mg

Group Type EXPERIMENTAL

Elacestrant

Intervention Type DRUG

Elacestrant 86 mg, 172 mg, 258 mg or 345 mg once daily in cycles of 28 days

Capivasertib

Intervention Type DRUG

Capivasertib 200 mg or 320 mg or 400 mg twice daily for 4 days on, 3 days off in cycles of 28 days

Interventions

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Elacestrant

Elacestrant 86 mg, 172 mg, 258 mg or 345 mg once daily in cycles of 28 days

Intervention Type DRUG

Alpelisib

Alpelisib 150 mg or 250 mg once daily in cycles of 28 days

Intervention Type DRUG

Everolimus

Everolimus 5 mg, 7.5 mg, or 10 mg once daily in cycles of 28 days

Intervention Type DRUG

Ribociclib

Ribociclib 400 mg or 600 mg once daily for 21 days followed by 7 days off in cycles of 28 days

Intervention Type DRUG

Palbociclib

Palbociclib 100 mg or 125 mg once daily for 21 days followed by 7 days off in cycles of 28 days

Intervention Type DRUG

Capivasertib

Capivasertib 200 mg or 320 mg or 400 mg twice daily for 4 days on, 3 days off in cycles of 28 days

Intervention Type DRUG

Abemaciclib

Abemaciclib 100 mg or 150 mg twice daily in cycles of 28 consecutive days

Intervention Type DRUG

Other Intervention Names

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Piqray Afinitor Kisqali Ibrance Truqap Verzenio

Eligibility Criteria

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Inclusion Criteria

1. Participant has signed the informed consent before all study specific activities are conducted.
2. Women or men aged ≥18 years (or the minimum age of consent in accordance with the local law), at the time of informed consent signature. Female participants may be of any menopausal status.

* Postmenopausal status is defined as follows or in accordance with local regulations:

1. Age ≥60 years or
2. Age \<60 years and amenorrhea for 12 or more months (without an alternative cause) and follicle-stimulating hormone value and an estradiol level within the postmenopausal range per local laboratory reference or
3. Documentation of bilateral oophorectomy, at least 1 month before first dose of trial therapy.
* Premenopausal and perimenopausal women (who do not fit postmenopausal criteria) and men must be receiving a luteinizing hormone-releasing hormone (LHRH) agonist and must be initiated at least 3 weeks (4 depending on local label) before the start of trial therapy and are planning to continue LHRH agonist treatment during the study treatment.
3. Histopathological or cytological confirmed ER+, HER2-, breast cancer, per local laboratory, as per the American Society of Clinical Oncology/College of American Pathologists guidelines. Note: In the context of this trial, ER status will be considered positive if ≥10% of tumor cells demonstrate positive nuclear staining by immunohistochemistry, with or without progesterone positivity.
4. Documented radiological disease progression during or after the most recent therapy.
5. At least 1 measurable lesion as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Tumor lesions previously irradiated or subjected to any locoregional treatment will only be considered measurable if there is clear, documented progression at the treated site. For participants with bone only disease, lesions: must be lytic or mixed (lytic + blastic / sclerotic), confirmed and accurately assessed by computed tomography or magnetic resonance imaging, and must have an identifiable soft tissue component meeting the definition of measurability per RECIST v1.1. Note: participants with blastic / sclerotic bone lesions only are not eligible.
6. Eastern Cooperative Oncology Group performance status of 0 or 1.
7. Participant has adequate bone marrow and organ function, as defined by the following laboratory values:

1. Absolute neutrophil count ≥1.5 × 10\^9/liter (L)
2. Platelets ≥100 × 10\^9/L
3. Hemoglobin ≥9.0 grams/deciliter (g/dL)
4. Creatinine is ≤ 1.5 x upper limit of normal (ULN) or if creatinine is \> 1.5 x ULN, then creatinine clearance must be ≥50 milliliters/minute based on the Cockcroft-Gault formula. Note: C-G formula:

* Creatinine clearance (male) = (\[140-age in years\] × weight in kilograms \[kg\])/ (\[serum creatinine in milligrams/deciliter (mg/dL)\] × 72)
* Creatinine clearance (female) = (0.85 × \[140-age in years\] × weight in kg)/ (\[serum creatinine in mg/dL\] × 72)

f. Serum albumin ≥3.0 g/dL (≥30 g/L)

g. In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN. If the participant has liver metastases, ALT and AST ≤ 5 × ULN

h. 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.

Additional Criteria for the Alpelisib Combination (Phase 1b and Arm A): In general, the prescription information of the respective combination drug should be consulted for instructions/restrictions with respect to interactions with concomitant medications.

1. Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA) mutation by local laboratory assessment.
2. One or up to two prior hormonal therapies in the advanced or metastatic setting, one of which was in combination with a cyclin-dependent kinase targeting enzymes CDK4 and CDK6 (CDK4/6) inhibitor.

Additional Criteria for the Everolimus Combination (Phase 1b and Arm B), the Abemaciclib Combination (Arm C), the Ribociclib Combination (Phase 1b and Arm C), and the Palbociclib Combination (Phase 1b): One or up to two prior hormonal therapies in the advanced or metastatic setting, one of which was in combination with a CDK4/6 inhibitor.

Additional Criteria for the Palbociclib Combination (Arm D), the Abemaciclib Combination (Arm D), and the Ribociclib Combination (Arm D): One or up to two prior hormonal therapies in the advanced or metastatic setting.

Additional Criteria for Capivasertib Combination (Phase 1b and Arm E): Recruitment in this combination will occur only in countries where capivasertib is locally approved and available.

1. PIK3CA/AKT1/PTEN-alteration as detected by an FDA and/or locally approved test (local result).
2. One or up to two prior hormonal therapies in the advanced or metastatic setting or participants who have radiological evidence of breast cancer recurrence or progression within 12 months from the end of adjuvant treatment with endocrine therapy, as these participants are considered as first line relapsed participants. Prior CDK4/6i treatment is allowed but not required.

Exclusion Criteria

1. Active or newly diagnosed central nervous system metastases, or meningeal carcinomatosis. Note: Participants with stable brain or subdural metastases are allowed if the participant has completed local therapy and was on a stable or decreasing dose of corticosteroids at baseline for management of brain metastasis for at least 4 weeks before starting treatment in this study. The dose must be ≤2.0 mg/day of dexamethasone or equivalent. Any signs (for example, radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment.
2. Participants with advanced, symptomatic visceral spread, who are at risk of life-threatening complications in the short term, including massive uncontrolled effusions (peritoneal, pleural, pericardial), pulmonary lymphangitis, or liver involvement \>50%.
3. Prior chemotherapy or elacestrant in the advanced/metastatic setting.
4. Participants with known germline BRCA mutation without prior treatment with a PARP inhibitor before study entry.
5. Prior therapy with elacestrant or other investigational selective estrogen receptor degraders, or investigational alike agents such as selective estrogen receptor modulators, selective estrogen receptor covalent antagonists, complete estrogen receptor antagonists, and proteolysis-targeting chimeras, in the metastatic setting. Prior treatment with fulvestrant is not exclusionary, except for Arm E, as it is an approved medication.
6. Participant has a concurrent malignancy or history of invasive malignancy within 3 years of enrollment, except basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix that has completed curative therapy. Other malignancies with low risk of recurrence may be considered eligible with Sponsor approval.
7. Uncontrolled significant active infections.

* Participants with hepatitis B virus and/or hepatitis C virus infection must have undetectable viral load during screening.
* Participants known to be human immunodeficiency virus+ are allowed if they have undetectable viral load at baseline.
8. Documented pneumonitis/interstitial lung disease prior to Cycle 1 Day 1.
9. Major surgery within 28 days before starting trial therapy.
10. Inability to take oral medications, refractory or chronic nausea, gastrointestinal conditions (including significant gastric or bowel resection), history of malabsorption syndrome, or any other uncontrolled gastrointestinal condition that impact the absorption of the study drug.
11. Known intolerance to elacestrant or any of its excipients.
12. Pregnant and breast-feeding women are excluded from the study. In addition, women of childbearing potential are excluded who:

* Within 28 days before starting trial therapy, did not use a highly effective method of contraception.
* Do not agree to use a highly effective method of contraception (Appendix F) or abstain from heterosexual intercourse throughout the entire study period and for 120 days after trial therapy discontinuation.
13. Men or women who do not agree to abstain from donating sperm or ova, or to use a highly effective method of contraception, 28 days prior, during the course of the treatment period and for 120 days after the last dose of study treatment.
14. Participant is currently receiving or received any of the following medications prior to first dose of trial therapy:

• Anti-cancer therapy within 14 days (28 days for anticancer antibody based treatment) or 5 half-lives, whichever is shorter.

Please note: Toxicity from prior therapy must be resolved to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 Grade ≤1, except alopecia and peripheral sensory neuropathy (Grade ≤2).
* Known strong or moderate inducers or inhibitors of cytochrome P450 (CYP) 3A4 within 14 days or 5 half-lives, whichever is shorter, (refer to https://drug-interactions.medicine.iu.edu/maintable.aspx or https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers).
* Herbal preparations/medications within 7 days. These include, but are not limited to, St. John's wort, kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone, yohimbe, saw palmetto, and ginseng.
* Vaccination, including but not limited to vaccination against COVID-19, during the 7 days prior to starting trial therapy.
15. Evidence of ongoing alcohol or drug abuse as assessed by the investigator.
16. Any severe medical or psychiatric condition that, in the Investigator's opinion, would preclude the participant's participation in a clinical study.

Additional Criteria for the Alpelisib Combination (Phase 1b and Arm A):

1. Prior therapy with alpelisib or any other phosphoinositide 3-kinase (PI3K) inhibitor.
2. Type 1 diabetes or uncontrolled type 2 diabetes (fasting plasma glucose level of \>140 mg/dL \[7.7 millimole (mmol)/L\], or glycosylated hemoglobin \[HbA1c\] level of \>6.4%).
3. Known intolerance to alpelisib or any of its excipients.
4. Participant is currently receiving or received drugs known to be a breast cancer resistant protein inhibitor (for example, curcumin, cyclosporine A, eltrombopag, febuxostat, fostamatinib, rolapitant, teriflunomide) within 14 days or 5 half-lives, whichever is shorter, prior to first dose of trial therapy (refer to Table 5.2 of https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers).
5. Participant has ongoing osteonecrosis of the jaw from previous or concurrent treatment with bisphosphonates or denosumab

Additional Criteria for the Everolimus Combination (Phase 1b and Arm B):

1. Prior therapy with everolimus.
2. Known intolerance to everolimus or any of its excipients.

Additional Criteria for the Abemaciclib Combination (Arm C):

1. Prior therapy with abemaciclib in the advanced or metastatic setting. Adjuvant therapy with abemaciclib is also exclusionary.
2. Known intolerance to abemaciclib or any of its excipients.
3. History of deep vein thrombosis or pulmonary embolism (unless on anticoagulation), cerebrovascular accident, or myocardial infarction, in the past 6 months. Participants on anticoagulation should have been on a stable dose for at least 3 months prior to enrollment.

Additional Criteria for the Ribociclib Combination (Phase 1b and Arm C):

1. Prior therapy with ribociclib in the advanced or metastatic setting. Prior adjuvant therapy with ribociclib is also exclusionary.
2. Known intolerance to ribociclib or any of its excipients.
3. QTcF interval corrected by Fridericia formula (QTcF) values ≥450 milliseconds (msec).
4. Participants who already have or who are at significant risk of developing QTc prolongation, including participants with:

* Long QT syndrome
* Uncontrolled or significant cardiac disease including recent (6 months) myocardial infarction, congestive heart failure, unstable angina, and brady-arrhythmias
* Electrolyte abnormalities (K+, Ca++, Phos, Mg++) ≥Grade 1
5. Participant is currently receiving or received drugs known to prolong QT interval within 14 days or 5 half-lives, whichever is shorter, before the first dose of trial therapy.

Additional Criteria for the Palbociclib Combination (Phase 1b):

1. Prior therapy with palbociclib in the advanced or metastatic setting.
2. Known intolerance to palbociclib or any of its excipients

Additional Criteria for the Palbociclib Combination (Arm D):

1. Prior therapy with a CDK4/6i in the metastatic setting.
2. Known intolerance to palbociclib or any of its excipients.

Additional Criteria for the Abemaciclib Combination (Arm D):

1. Prior therapy with any CDK4/6i.
2. Known intolerance to abemaciclib or any of its excipients.

Additional Criteria for Ribociclib Combination (Arm D):

1. Prior therapy with a CDK4/6i in the advanced or metastatic setting.
2. Known intolerance to ribociclib or any of its excipients.
3. QTcF values ≥450 msec.
4. Participants who already have or who are at significant risk of developing QTc prolongation, including participants with:

* Long QT syndrome
* Uncontrolled or significant cardiac disease including recent (6 months) myocardial infarction, congestive heart failure, unstable angina, and brady-arrhythmias
* Electrolyte abnormalities (K+, Ca++, Phos, Mg++) ≥Grade 1
5. Participant is currently receiving or received drugs known to prolong QT interval within 14 days or 5 half-lives, whichever is shorter, before the first dose of trial therapy.

Additional Criteria for Capivasertib Combination (Phase 1b and Arm E): Recruitment in this combination will occur only in countries where capivasertib is locally approved and available.

1. Prior treatment with any of the following: AKT, PI3K and mammalian target of rapamycin inhibitors and, for Arm E, fulvestrant.
2. Known intolerance to capivasertib or any of its excipients.
3. QTcF values ≥470 msec or factors that increase the risk of corrected QT interval (QTc) prolongation or risk of arrhythmic events such as heart failure, hypokalemia, potential for torsades de pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age, or any concomitant medication known to prolong the QT interval.
4. Clinically significant abnormalities of glucose metabolism as defined by any of the following: Participants with diabetes mellitus type 1; participants with diabetes mellitus type 2 requiring insulin treatment or participants with HbA1c level of \>8.0% (63.9 mmol/mol).
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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Dothan Hematology and Oncology

Dothan, Alabama, United States

Site Status RECRUITING

Mayo Clinic - Arizona

Phoenix, Arizona, United States

Site Status RECRUITING

Highlands Oncology Group

Springdale, Arkansas, United States

Site Status RECRUITING

OPN Healthcare (Arcadia Location)

Arcadia, California, United States

Site Status WITHDRAWN

City of Hope National Medical Center

Duarte, California, United States

Site Status NOT_YET_RECRUITING

Glendale Adventist

Glendale, California, United States

Site Status WITHDRAWN

OPN Healthcare (Los Alamitos Location)

Los Alamitos, California, United States

Site Status RECRUITING

Cedars Sinai

Los Angeles, California, United States

Site Status RECRUITING

UCLA UCLA Hem/Onc - Clinical Research Unit

Los Angeles, California, United States

Site Status RECRUITING

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Site Status RECRUITING

TOI Clinical Research

Whittier, California, United States

Site Status COMPLETED

Rocky Mountain Cancer Centers

Lone Tree, Colorado, United States

Site Status RECRUITING

Yale School Of Medicine - Smilow Cancer Hospital - Breast Center

New Haven, Connecticut, United States

Site Status WITHDRAWN

George Washington Cancer Center

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Advent Health (Florida Hospital) - Altamonte Springs

Altamonte Springs, Florida, United States

Site Status RECRUITING

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Site Status RECRUITING

Ocala Oncology

Ocala, Florida, United States

Site Status WITHDRAWN

Northside Hospital Atlanta Cancer Care

Cumming, Georgia, United States

Site Status WITHDRAWN

Northwestern Feinberg Scholl of Medicine Prentice Women's Hospital

Chicago, Illinois, United States

Site Status RECRUITING

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, United States

Site Status WITHDRAWN

MD Alliance for Multispecialty Research, LLC

Merriam, Kansas, United States

Site Status RECRUITING

New England Cancer Specialists

Scarborough, Maine, United States

Site Status WITHDRAWN

Johns Hopkins School of Medicine

Baltimore, Maryland, United States

Site Status RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status RECRUITING

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status RECRUITING

Minnesota Oncology Hematology

Minneapolis, Minnesota, United States

Site Status WITHDRAWN

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Washington University School of Medicine in St. Louis

St Louis, Missouri, United States

Site Status RECRUITING

Astera Cancer Care

East Brunswick, New Jersey, United States

Site Status RECRUITING

Summit Medical Group

Florham Park, New Jersey, United States

Site Status RECRUITING

Cooperman Barnabas Medical Center

New Brunswick, New Jersey, United States

Site Status RECRUITING

NYU Langone Health

New York, New York, United States

Site Status RECRUITING

New York Cancer and Blood Specialists

Port Jefferson Station, New York, United States

Site Status WITHDRAWN

W&IH of RI Breast Health Center of Women and Infants Hospital of Rhode Island

Providence, Rhode Island, United States

Site Status RECRUITING

Sarah Cannon Research Institute / Tennessee Oncology

Nashville, Tennessee, United States

Site Status RECRUITING

Texas Oncology - Baylor Charles A. Sammons Cancer Center

Dallas, Texas, United States

Site Status RECRUITING

MD Anderson Cancer Center Texas

Houston, Texas, United States

Site Status RECRUITING

UT Health San Antonio

San Antonio, Texas, United States

Site Status RECRUITING

Inova Schar Cancer Institute

Fairfax, Virginia, United States

Site Status WITHDRAWN

Virginia Cancer Specialists

Fairfax, Virginia, United States

Site Status RECRUITING

Virginia Oncology Associates

Norfolk, Virginia, United States

Site Status RECRUITING

Cancer Care Northwest

Spokane Valley, Washington, United States

Site Status RECRUITING

Northwest Medical Specialties (Nwms) - Puyallup - Medical Oncology (Rainier Hematology-Oncology)/Exigent Research Network; LLC

Tacoma, Washington, United States

Site Status RECRUITING

University of WI - Carbone Cancer Center (Phase II only)

Madison, Wisconsin, United States

Site Status RECRUITING

Centro Medico Austral

Buenos Aires, , Argentina

Site Status RECRUITING

Hospital Britanico De Buenos Aires

Buenos Aires, , Argentina

Site Status WITHDRAWN

Cemaic - Centro De Especialidades Medicas Ambulatorias E Investigacion Clinica

Córdoba, , Argentina

Site Status RECRUITING

Centro Oncologico Riojano Integral (Cori)

La Rioja, , Argentina

Site Status RECRUITING

Macquarie University

Sydney, , Australia

Site Status RECRUITING

Institut Jules Bordet

Anderlecht, , Belgium

Site Status RECRUITING

Grand Hôpital de Charleroi - Site Notre Dame

Charleroi, , Belgium

Site Status RECRUITING

Universitaire Ziekenhuizen (Uz) Leuven - Campus Gasthuisberg - Multidisciplinair Borstcentrum (Multidisciplinary Breast Center) (Mbc)

Leuven, , Belgium

Site Status RECRUITING

Algemeen Ziekenhuis Nikolaas; VITAZ; Oncologie Klinisch Studiecentrum

Sint-Niklaas, , Belgium

Site Status WITHDRAWN

ACCG - Hospital Araujo Jorge

Goiânia, , Brazil

Site Status RECRUITING

Clinica Neoplasias Litoral

Itajaí, , Brazil

Site Status RECRUITING

Hospital Sao Lucas da PUCRS

Porto Alegre, , Brazil

Site Status RECRUITING

Centro Gaucho Integrado de Oncologia; Hematologia; Ensino e Pesquisa - Hospital Mae de Deus/AESC

Porto Alegre, , Brazil

Site Status RECRUITING

Hospital Sirio-Libanes (HSL) - Centro De Oncologia - Sao Paulo

São Paulo, , Brazil

Site Status RECRUITING

Nemocnice Horovice Hospital

Hořovice, , Czechia

Site Status WITHDRAWN

Fakultni Nemocnice Olomouc

Olomouc, , Czechia

Site Status WITHDRAWN

Centre Hospitalier Lyon SUD- HCL

Lyon, , France

Site Status RECRUITING

Centre de Cancérologie du Grand Montpellier

Montpellier, , France

Site Status RECRUITING

Centre de Cancérologie du Grand Montpellier

Rouen, , France

Site Status RECRUITING

Centre Hospitalier Universitaire (Chu) De Toulouse - Institut Universitaire Du Cancer De Toulouse-Oncopole (Iuct-Oncopole) (Institut Claudius Regaud)

Toulouse, , France

Site Status RECRUITING

Institut Gustave-Roussy-Umr 981

Villejuif, , France

Site Status RECRUITING

Universitaetsklinikum Mannheim

Mannheim, Baden-Wurttemberg, Germany

Site Status WITHDRAWN

Technischen Universitaet Muenchen (TUM), Klinikum Rechts der Isar

Munich, Bavaria, Germany

Site Status WITHDRAWN

Universitatskinikum Carl Gustav Carus Dresden

Dresden, Saxony, Germany

Site Status WITHDRAWN

Marienhospital Bottrop

Bottrop, , Germany

Site Status WITHDRAWN

Universitatskinikum Carl Gustav Carus Dresden

Dresden, , Germany

Site Status WITHDRAWN

Kliniken Essen-Mitte (KEM)

Essen, , Germany

Site Status WITHDRAWN

Gesundheit Nordhessen Klinikum Kassel

Kassel, , Germany

Site Status WITHDRAWN

Universitaetsklinikum Tuebingen

Tübingen, , Germany

Site Status WITHDRAWN

Semmelweis Egyetem Klinikai Kozpont - Onkologiai Intezet

Budapest, , Hungary

Site Status WITHDRAWN

Orszagos Onkologiai Intezet

Budapest, , Hungary

Site Status WITHDRAWN

Samson Assuta Ashdod University Hospital - The Institute of Oncology

Ashdod, , Israel

Site Status RECRUITING

Rambam Heath

Haifa, , Israel

Site Status RECRUITING

Shaare Zedek Medical Center

Jerusalem, , Israel

Site Status RECRUITING

Davidoff Rabin Medical Center

Petah Tikva, , Israel

Site Status RECRUITING

Sheba Medical Center; Center Israel

Ramat Gan, , Israel

Site Status RECRUITING

ASST degli Spedali Civili di Brescia

Brescia, , Italy

Site Status RECRUITING

Azienda Ospedaliera "Istituti Ospitalieri" Di Cremona

Cremona, , Italy

Site Status WITHDRAWN

Istituto Europeo di Oncologia (IEO)

Milan, , Italy

Site Status RECRUITING

Istituto Nazionale Tumori "Fondazione PASCALE"

Napoli, , Italy

Site Status RECRUITING

Azienda Ospedaliero-Universitaria Pisana

Pisa, , Italy

Site Status WITHDRAWN

Ospedale Infermi di Rimini - Azienda Unita Sanitaria Locale Della Romagna

Rimini, , Italy

Site Status RECRUITING

Centre Hospitalier De L'Ardenne

Libramont, , Luxembourg

Site Status RECRUITING

Klinika Onkologii; Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy

Warsaw, Masovian Voivodeship, Poland

Site Status WITHDRAWN

Przychodnia Lekarska "Komed" Roman Karaszewski

Konin, , Poland

Site Status WITHDRAWN

Instytut Centrum Zdrowia Matki Polki

Lodz, , Poland

Site Status WITHDRAWN

Med-Polonia Sp. Z o.o.

Poznan, , Poland

Site Status WITHDRAWN

Seoul National University Bundang Hospital

Seongnam-si, , South Korea

Site Status RECRUITING

Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Gangnam Severance Hospital

Seoul, , South Korea

Site Status RECRUITING

The Catholic University of Korea - Seoul St. Mary's Hospital

Seoul, , South Korea

Site Status WITHDRAWN

Korea University Anam Hospital

Seoul, , South Korea

Site Status WITHDRAWN

Ulsan University Hospital

Ulsan, , South Korea

Site Status WITHDRAWN

Complejo Hospitalario Universitario A Coruna

A Coruña, , Spain

Site Status RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status RECRUITING

Hospital Clinic Barcelona

Barcelona, , Spain

Site Status RECRUITING

Hospital General Universitario Gregorio Maranon

Madrid, , Spain

Site Status RECRUITING

IOB Madrd Institute of Oncology Hospital Beata Maria Ana de Jesus

Madrid, , Spain

Site Status RECRUITING

Hospital Clinico San Carlos

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario La Paz

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Virgen de la Victoria

Málaga, , Spain

Site Status RECRUITING

NEXT Madrid

Pozuelo de Alarcón, , Spain

Site Status RECRUITING

Fundacion Instituto Valeciano De Oncologia

Valencia, , Spain

Site Status RECRUITING

Hospital Clinico Universitario de Valencia

Valencia, , Spain

Site Status RECRUITING

Hospital Arnau De Vilanova

Valencia, , Spain

Site Status RECRUITING

Abdurrahman Yurtaslan Oncology Hospital

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Ankara Bilkent City Hospital, Bilkent Campus, Universiteler Mh. (old: Ankara Yildirim Beyazit Universitesi)

Ankara, , Turkey (Türkiye)

Site Status WITHDRAWN

The Clatterbridge Cancer Centre NHS Foundation Trust

Liverpool, , United Kingdom

Site Status RECRUITING

Liverpool Hospital

Liverpool, , United Kingdom

Site Status WITHDRAWN

North Middlesex University Hospital

London, , United Kingdom

Site Status RECRUITING

Sarah Cannon Research Institute UK; Ltd

London, , United Kingdom

Site Status RECRUITING

University College London Hospitals NHS Foundation Trust; The London Clinic - Main Hospital

London, , United Kingdom

Site Status RECRUITING

Countries

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United States Argentina Australia Belgium Brazil Czechia France Germany Hungary Israel Italy Luxembourg Poland South Korea Spain Turkey (Türkiye) United Kingdom

Central Contacts

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Stemline Trials

Role: CONTACT

1-877-332-7961

Other Identifiers

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STML-ELA-0222

Identifier Type: -

Identifier Source: org_study_id

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