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AzTrials

Breast CancerPhase 1/2ELEVATENCT05563220

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

A Phase 1/2 study testing Elacestrant, Alpelisib and Everolimus in people with Breast Cancer and Metastatic Breast Cancer, run by Stemline Therapeutics, Inc. at 83 sites in 13 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer, Metastatic Breast Cancer
What is being tested?
Elacestrant, Alpelisib and Everolimus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
435 participants
Where
83 sitesin 13 countries
Study dates
24 Jan 2023to 28 Dec 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant has signed the informed consent before all study specific activities are conducted.
  • 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:
  • Age ≥60 years or
  • 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
  • Documentation of bilateral oophorectomy, at least 1 month before first dose of trial therapy.
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  • 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.
  • 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.
  • Documented radiological disease progression during or after the most recent therapy.
  • 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.
  • Eastern Cooperative Oncology Group performance status of 0 or 1.
  • Participant has adequate bone marrow and organ function, as defined by the following laboratory values:
  • Absolute neutrophil count ≥1.5 × 10^9/liter (L)
  • Platelets ≥100 × 10^9/L
  • Hemoglobin ≥9.0 grams/deciliter (g/dL)
  • 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)
  • Serum albumin ≥3.0 g/dL (≥30 g/L)
  • 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
  • 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.
  • Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA) mutation by local laboratory assessment.
  • 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.
  • PIK3CA/AKT1/PTEN-alteration as detected by an FDA and/or locally approved test (local result).
  • 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.

Who cannot join

  • 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.
  • 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%.
  • Prior chemotherapy or elacestrant in the advanced/metastatic setting.
  • Participants with known germline BRCA mutation without prior treatment with a PARP inhibitor before study entry.
  • 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.
  • 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.
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  • 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.
  • Documented pneumonitis/interstitial lung disease prior to Cycle 1 Day 1.
  • Major surgery within 28 days before starting trial therapy.
  • 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.
  • Known intolerance to elacestrant or any of its excipients.
  • 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.
  • 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.
  • 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.
  • Evidence of ongoing alcohol or drug abuse as assessed by the investigator.
  • 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):
  • Prior therapy with alpelisib or any other phosphoinositide 3-kinase (PI3K) inhibitor.
  • 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%).
  • Known intolerance to alpelisib or any of its excipients.
  • 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).
  • 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):
  • Prior therapy with everolimus.
  • Known intolerance to everolimus or any of its excipients.
  • Additional Criteria for the Abemaciclib Combination (Arm C):
  • Prior therapy with abemaciclib in the advanced or metastatic setting. Adjuvant therapy with abemaciclib is also exclusionary.
  • Known intolerance to abemaciclib or any of its excipients.
  • 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):
  • Prior therapy with ribociclib in the advanced or metastatic setting. Prior adjuvant therapy with ribociclib is also exclusionary.
  • Known intolerance to ribociclib or any of its excipients.
  • QTcF interval corrected by Fridericia formula (QTcF) values ≥450 milliseconds (msec).
  • 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
  • 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):
  • Prior therapy with palbociclib in the advanced or metastatic setting.
  • Known intolerance to palbociclib or any of its excipients
  • Additional Criteria for the Palbociclib Combination (Arm D):
  • Prior therapy with a CDK4/6i in the metastatic setting.
  • Known intolerance to palbociclib or any of its excipients.
  • Additional Criteria for the Abemaciclib Combination (Arm D):
  • Prior therapy with any CDK4/6i.
  • Known intolerance to abemaciclib or any of its excipients.
  • Additional Criteria for Ribociclib Combination (Arm D):
  • Prior therapy with a CDK4/6i in the advanced or metastatic setting.
  • Known intolerance to ribociclib or any of its excipients.
  • QTcF values ≥450 msec.
  • 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
  • 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.
  • Prior treatment with any of the following: AKT, PI3K and mammalian target of rapamycin inhibitors and, for Arm E, fulvestrant.
  • Known intolerance to capivasertib or any of its excipients.
  • 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.
  • 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).

Trial locations and contacts

83 sites in 13 countries.

83 sites in 13 countries

United States35 sites

  • Advent Health (Florida Hospital) - Altamonte Springs

    Altamonte Springs, Florida, 32701

  • Johns Hopkins School of Medicine

    Baltimore, Maryland, 21287

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Northwestern Feinberg Scholl of Medicine Prentice Women's Hospital

    Chicago, Illinois, 60611

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Dothan Hematology and Oncology

    Dothan, Alabama, 36303

  • City of Hope National Medical Center

    Duarte, California, 91010

  • Astera Cancer Care

    East Brunswick, New Jersey, 08816

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • Summit Medical Group

    Florham Park, New Jersey, 07932

  • MD Anderson Cancer Center Texas

    Houston, Texas, 77030

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • Rocky Mountain Cancer Centers

    Lone Tree, Colorado, 80124

  • OPN Healthcare (Los Alamitos Location)

    Los Alamitos, California, 90720

  • Cedars Sinai

    Los Angeles, California, 90048

  • UCLA UCLA Hem/Onc - Clinical Research Unit

    Los Angeles, California, 90095

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

    Madison, Wisconsin, 53792

  • MD Alliance for Multispecialty Research, LLC

    Merriam, Kansas, 66204

  • Sarah Cannon Research Institute / Tennessee Oncology

    Nashville, Tennessee, 37203

  • Cooperman Barnabas Medical Center

    New Brunswick, New Jersey, 08901

  • NYU Langone Health

    New York, New York, 10016

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Mayo Clinic - Arizona

    Phoenix, Arizona, 85054

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

    Providence, Rhode Island, 02905

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905

  • UT Health San Antonio

    San Antonio, Texas, 78229

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94158

  • Cancer Care Northwest

    Spokane Valley, Washington, 99216

  • Highlands Oncology Group

    Springdale, Arkansas, 72762

  • Washington University School of Medicine in St. Louis

    St Louis, Missouri, 63110

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

    Tacoma, Washington, 98405

  • George Washington Cancer Center

    Washington D.C., District of Columbia, 20037

  • TOI Clinical Research

    Whittier, California, 90603

Other trials in United States

Spain13 sites

  • Complejo Hospitalario Universitario A Coruna

    A Coruña, 15006

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic Barcelona

    Barcelona, 08036

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • IOB Madrd Institute of Oncology Hospital Beata Maria Ana de Jesus

    Madrid, 28007

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

  • NEXT Madrid

    Pozuelo de Alarcón, 28223

  • Fundacion Instituto Valeciano De Oncologia

    Valencia, 46009

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospital Arnau De Vilanova

    Valencia, 46015

Other trials in Spain

Brazil5 sites

  • ACCG - Hospital Araujo Jorge

    Goiânia, 74605-070

  • Clinica Neoplasias Litoral

    Itajaí, 88301-220

  • Hospital Sao Lucas da PUCRS

    Porto Alegre, 90610-000

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

    Porto Alegre, 90850-170

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

    São Paulo, 01308-050

Other trials in Brazil

France5 sites

  • Centre Hospitalier Lyon SUD- HCL

    Lyon, 69495

  • Centre de Cancérologie du Grand Montpellier

    Montpellier, 34070

  • Centre de Cancérologie du Grand Montpellier

    Rouen, 76038 Cedex 1

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

    Toulouse, 31059 Cedex 09

  • Institut Gustave-Roussy-Umr 981

    Villejuif, 94805

Other trials in France

Israel5 sites

  • Samson Assuta Ashdod University Hospital - The Institute of Oncology

    Ashdod, 7747629

  • Rambam Heath

    Haifa, 352408

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Davidoff Rabin Medical Center

    Petah Tikva, 49100

  • Sheba Medical Center; Center Israel

    Ramat Gan, 5265601

Other trials in Israel

Italy4 sites

  • ASST degli Spedali Civili di Brescia

    Brescia, 25123

  • Istituto Europeo di Oncologia (IEO)

    Milan, 20141

  • Istituto Nazionale Tumori "Fondazione PASCALE"

    Naples, 80131

  • Ospedale Infermi di Rimini - Azienda Unita Sanitaria Locale Della Romagna

    Rimini, 47923

Other trials in Italy

United Kingdom4 sites

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Liverpool, L7 8YA

  • North Middlesex University Hospital

    London, N18 1QX

  • Sarah Cannon Research Institute UK; Ltd

    London, W1G 6AD

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

    London, W1T 7HA

Other trials in United Kingdom

Argentina3 sites

  • Centro Medico Austral

    Buenos Aires, C1017AAS

  • Cemaic - Centro De Especialidades Medicas Ambulatorias E Investigacion Clinica

    Córdoba, X5008HHW

  • Centro Oncologico Riojano Integral (Cori)

    La Rioja, 01122

Other trials in Argentina

Belgium3 sites

  • Institut Jules Bordet

    Anderlecht, 01070

  • Grand Hôpital de Charleroi - Site Notre Dame

    Charleroi, 06000

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

    Leuven, 03000

Other trials in Belgium

South Korea3 sites

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • Asan Medical Center

    Seoul, 05505

  • Gangnam Severance Hospital

    Seoul, 06273

Other trials in South Korea

Australia1 site

  • Macquarie University

    Sydney, 2113

Other trials in Australia

Luxembourg1 site

  • Centre Hospitalier De L'Ardenne

    Libramont, 06800

Other trials in Luxembourg

Turkey (Türkiye)1 site

  • Abdurrahman Yurtaslan Oncology Hospital

    Ankara, 0*6200

Other trials in Turkey (Türkiye)

About this study

Official title: A Phase 1b/2, Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer

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.

Read the detailed description

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.

Being tested
Elacestrant, Alpelisib, Everolimus, Ribociclib, Palbociclib
Keywords
breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ElacestrantDrug

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

  • AlpelisibDrug

    Also called Piqray

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

  • EverolimusDrug

    Also called Afinitor

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

  • RibociclibDrug

    Also called Kisqali

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

  • PalbociclibDrug

    Also called Ibrance

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

  • CapivasertibDrug

    Also called Truqap

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

  • AbemaciclibDrug

    Also called Verzenio

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

Study groups in NCT05563220
Study groupRoleWhat they receive
Phase 1b Arm A: elacestrant with alpelisibExperimentalElacestrant Dihydrochloride 300 milligrams (mg) or 400 mg + Alpelisib 150 mg to 250 mg
Receives: Drug: Elacestrant; Drug: Alpelisib
Phase 1b Arm B: elacestrant with everolimusExperimentalElacestrant Dihydrochloride 300 mg or 400 mg + Everolimus 5.0 mg, 7.5 mg or possibly 10 mg
Receives: Drug: Elacestrant; Drug: Everolimus
Phase 1b Arm C: elacestrant with abemaciclib or ribociclib:ExperimentalElacestrant 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)
Receives: Drug: Elacestrant; Drug: Ribociclib; Drug: Abemaciclib
Phase 1b Arm D: elacestrant with either palbociclib, abemaciclib, or ribociclib (no prior CDK4/6i)ExperimentalElacestrant 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
Receives: Drug: Elacestrant; Drug: Ribociclib; Drug: Palbociclib; Drug: Abemaciclib
Phase 1b Arm E:ExperimentalElacestrant Dihydrochloride 300 mg, 400 mg + Capivasertib 200 mg, 320 mg, 400 mg
Receives: Drug: Elacestrant; Drug: Capivasertib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with DLTs Observed During the First Cycle

    Number of dose-limiting toxicities during the first cycle

    Measured: 28 days

  2. Progression-free Survival

    The time from the date of the first dose to the date of the first radiological documentation of disease progression or death, whichever comes first.

    Measured: 6 months

Secondary outcomes (6)

  1. Standard Pharmacokinetics (PK) Parameters Including AUC0-tau, Cmax, Tmax, and Ctrough

    The plasma PK of elacestrant and each of the combination drugs

    Measured: 36 months

  2. Overall Response Rate

    Proportion of participants who achieve a best overall response of confirmed partial response (PR) or complete response (CR)

    Measured: 36 months

  3. Duration of Response

    Time from the date of the first documented CR/PR until the first radiological documentation of disease progression or death

    Measured: 36 months

  4. Clinical Benefit Rate

    Proportion of participants who have the best overall response with a complete response, partial response or stable disease

    Measured: 36 months

  5. Progression-free Survival Rate

    Time from the date of the first dose to the date of the first radiological documentation of disease progression or death, whichever comes first

    Measured: 36 months

  6. Overall Survival

    Time from the date of the first dose to the date of death from any cause

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2022
  2. Study start24 Jan 2023
  3. Primary completion27 Dec 2026 (estimated)
  4. Study completion28 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
435 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05563220
Sponsor's protocol ID
STML-ELA-0222
Acronym
ELEVATE
Status last verified
Jun 2026
First submitted
22 Sep 2022
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Elacestrant, Alpelisib and Everolimus in people with Breast Cancer and Metastatic Breast Cancer, run by Stemline Therapeutics, Inc. at 83 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 70 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in United States, Spain, Brazil, France, Israel and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with DLTs Observed During the First Cycle (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05563220.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.

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