Actively Recruiting
Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer
Led by Stemline Therapeutics, Inc. · Updated on 2026-01-06
435
Participants Needed
118
Research Sites
309 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant has signed informed consent before any study activities.
- Women or men aged 18 years or older at the time of consent.
- Female participants may be of any menopausal status; postmenopausal status defined by age, amenorrhea, hormone levels, or bilateral oophorectomy.
- Premenopausal and perimenopausal women and men must be receiving luteinizing hormone-releasing hormone (LHRH) agonist treatment started at least 3-4 weeks before trial therapy and planned to continue during treatment.
- Histopathological or cytological confirmed ER+, HER2- breast cancer per guidelines.
- Documented radiological disease progression during or after most recent therapy.
- At least one measurable lesion per RECIST v1.1 criteria.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Adequate bone marrow and organ function based on specified laboratory values.
- Additional criteria specific to combination arms regarding prior therapies, mutations, and local drug approval.
You will not qualify if you...
- Active or newly diagnosed central nervous system metastases or meningeal carcinomatosis, except stable brain/subdural metastases with stable or decreasing corticosteroid use.
- Advanced symptomatic visceral spread with risk of life-threatening complications.
- Prior chemotherapy or elacestrant in advanced/metastatic setting.
- Known germline BRCA mutation without prior PARP inhibitor treatment.
- Prior therapy with investigational selective estrogen receptor degraders or similar agents in metastatic setting.
- Concurrent malignancy or history of invasive malignancy within 3 years, except certain skin, bladder, or cervical cancers.
- Uncontrolled active infections including hepatitis B/C or HIV with detectable viral load.
- Documented pneumonitis or interstitial lung disease before treatment.
- Major surgery within 28 days before trial therapy.
- Inability to take oral medications or uncontrolled gastrointestinal conditions affecting drug absorption.
- Known intolerance to elacestrant or its excipients.
- Pregnant or breastfeeding women; women not using highly effective contraception.
- Men or women not agreeing to abstain from sperm/ova donation or contraception use during and after treatment.
- Recent anti-cancer therapy or medications affecting cytochrome P450 3A4 or herbal supplements.
- Evidence of alcohol or drug abuse.
- Severe medical or psychiatric conditions precluding participation.
- Additional exclusion criteria specific to each combination regarding prior therapies, intolerances, cardiac issues, diabetes, and QT interval prolongation risks.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 118 locations
1
Dothan Hematology and Oncology
Dothan, Alabama, United States, 36303
Actively Recruiting
2
Mayo Clinic - Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
3
Highlands Oncology Group
Springdale, Arkansas, United States, 72762
Actively Recruiting
4
OPN Healthcare (Arcadia Location)
Arcadia, California, United States, 91007
Withdrawn
5
City of Hope National Medical Center
Duarte, California, United States, 91010
Not Yet Recruiting
6
Glendale Adventist
Glendale, California, United States, 91206
Withdrawn
7
OPN Healthcare (Los Alamitos Location)
Los Alamitos, California, United States, 90720
Actively Recruiting
8
Cedars Sinai
Los Angeles, California, United States, 90048
Actively Recruiting
9
UCLA UCLA Hem/Onc - Clinical Research Unit
Los Angeles, California, United States, 90095
Actively Recruiting
10
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94158
Actively Recruiting
11
TOI Clinical Research
Whittier, California, United States, 90603
Completed
12
Rocky Mountain Cancer Centers
Lone Tree, Colorado, United States, 80124
Actively Recruiting
13
Yale School Of Medicine - Smilow Cancer Hospital - Breast Center
New Haven, Connecticut, United States, 06519
Withdrawn
14
George Washington Cancer Center
Washington D.C., District of Columbia, United States, 20037
Actively Recruiting
15
Advent Health (Florida Hospital) - Altamonte Springs
Altamonte Springs, Florida, United States, 32701
Actively Recruiting
16
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
Actively Recruiting
17
Ocala Oncology
Ocala, Florida, United States, 34474
Withdrawn
18
Northside Hospital Atlanta Cancer Care
Cumming, Georgia, United States, 30041
Withdrawn
19
Northwestern Feinberg Scholl of Medicine Prentice Women's Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
20
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States, 46804
Withdrawn
21
MD Alliance for Multispecialty Research, LLC
Merriam, Kansas, United States, 66204
Actively Recruiting
22
New England Cancer Specialists
Scarborough, Maine, United States, 04074
Withdrawn
23
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21287
Actively Recruiting
24
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
25
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
26
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
27
Minnesota Oncology Hematology
Minneapolis, Minnesota, United States, 55404
Withdrawn
28
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
29
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
30
Astera Cancer Care
East Brunswick, New Jersey, United States, 08816
Actively Recruiting
31
Summit Medical Group
Florham Park, New Jersey, United States, 07932
Actively Recruiting
32
Cooperman Barnabas Medical Center
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
33
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
34
New York Cancer and Blood Specialists
Port Jefferson Station, New York, United States, 11776
Withdrawn
35
W&IH of RI Breast Health Center of Women and Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
Actively Recruiting
36
Sarah Cannon Research Institute / Tennessee Oncology
Nashville, Tennessee, United States, 37203
Actively Recruiting
37
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
Actively Recruiting
38
MD Anderson Cancer Center Texas
Houston, Texas, United States, 77030
Actively Recruiting
39
UT Health San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
40
Inova Schar Cancer Institute
Fairfax, Virginia, United States, 22031
Withdrawn
41
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
42
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Actively Recruiting
43
Cancer Care Northwest
Spokane Valley, Washington, United States, 99216
Actively Recruiting
44
Northwest Medical Specialties (Nwms) - Puyallup - Medical Oncology (Rainier Hematology-Oncology)/Exigent Research Network; LLC
Tacoma, Washington, United States, 98405
Actively Recruiting
45
University of WI - Carbone Cancer Center (Phase II only)
Madison, Wisconsin, United States, 53792
Actively Recruiting
46
Centro Medico Austral
Buenos Aires, Argentina, C1017AAS
Actively Recruiting
47
Hospital Britanico De Buenos Aires
Buenos Aires, Argentina, C1280 AEB
Withdrawn
48
Cemaic - Centro De Especialidades Medicas Ambulatorias E Investigacion Clinica
Córdoba, Argentina, X5008HHW
Actively Recruiting
49
Centro Oncologico Riojano Integral (Cori)
La Rioja, Argentina, 01122
Actively Recruiting
50
Macquarie University
Sydney, Australia, 2113
Actively Recruiting
51
Institut Jules Bordet
Anderlecht, Belgium, 01070
Actively Recruiting
52
Grand Hôpital de Charleroi - Site Notre Dame
Charleroi, Belgium, 06000
Actively Recruiting
53
Universitaire Ziekenhuizen (Uz) Leuven - Campus Gasthuisberg - Multidisciplinair Borstcentrum (Multidisciplinary Breast Center) (Mbc)
Leuven, Belgium, 03000
Actively Recruiting
54
Algemeen Ziekenhuis Nikolaas; VITAZ; Oncologie Klinisch Studiecentrum
Sint-Niklaas, Belgium, 09100
Withdrawn
55
ACCG - Hospital Araujo Jorge
Goiânia, Brazil, 74605-070
Actively Recruiting
56
Clinica Neoplasias Litoral
Itajaí, Brazil, 88301-220
Actively Recruiting
57
Hospital Sao Lucas da PUCRS
Porto Alegre, Brazil, 90610-000
Actively Recruiting
58
Centro Gaucho Integrado de Oncologia; Hematologia; Ensino e Pesquisa - Hospital Mae de Deus/AESC
Porto Alegre, Brazil, 90850-170
Actively Recruiting
59
Hospital Sirio-Libanes (HSL) - Centro De Oncologia - Sao Paulo
São Paulo, Brazil, 01308-050
Actively Recruiting
60
Nemocnice Horovice Hospital
Hořovice, Czechia, 26831
Withdrawn
61
Fakultni Nemocnice Olomouc
Olomouc, Czechia, 77900
Withdrawn
62
Centre Hospitalier Lyon SUD- HCL
Lyon, France, 69495
Actively Recruiting
63
Centre de Cancérologie du Grand Montpellier
Montpellier, France, 34070
Actively Recruiting
64
Centre de Cancérologie du Grand Montpellier
Rouen, France, 76038 Cedex 1
Actively Recruiting
65
Centre Hospitalier Universitaire (Chu) De Toulouse - Institut Universitaire Du Cancer De Toulouse-Oncopole (Iuct-Oncopole) (Institut Claudius Regaud)
Toulouse, France, 31059 Cedex 09
Actively Recruiting
66
Institut Gustave-Roussy-Umr 981
Villejuif, France, 94805
Actively Recruiting
67
Universitaetsklinikum Mannheim
Mannheim, Baden-Wurttemberg, Germany, 68167
Withdrawn
68
Technischen Universitaet Muenchen (TUM), Klinikum Rechts der Isar
Munich, Bavaria, Germany, 81675
Withdrawn
69
Universitatskinikum Carl Gustav Carus Dresden
Dresden, Saxony, Germany, 01307
Withdrawn
70
Marienhospital Bottrop
Bottrop, Germany, 46236
Withdrawn
71
Universitatskinikum Carl Gustav Carus Dresden
Dresden, Germany, 01307
Withdrawn
72
Kliniken Essen-Mitte (KEM)
Essen, Germany, 45136
Withdrawn
73
Gesundheit Nordhessen Klinikum Kassel
Kassel, Germany, 34125
Withdrawn
74
Universitaetsklinikum Tuebingen
Tübingen, Germany, 72076
Withdrawn
75
Semmelweis Egyetem Klinikai Kozpont - Onkologiai Intezet
Budapest, Hungary, 01083
Withdrawn
76
Orszagos Onkologiai Intezet
Budapest, Hungary, 01122
Withdrawn
77
Samson Assuta Ashdod University Hospital - The Institute of Oncology
Ashdod, Israel, 7747629
Actively Recruiting
78
Rambam Heath
Haifa, Israel, 352408
Actively Recruiting
79
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102
Actively Recruiting
80
Davidoff Rabin Medical Center
Petah Tikva, Israel, 49100
Actively Recruiting
81
Sheba Medical Center; Center Israel
Ramat Gan, Israel, 5265601
Actively Recruiting
82
ASST degli Spedali Civili di Brescia
Brescia, Italy, 25123
Actively Recruiting
83
Azienda Ospedaliera "Istituti Ospitalieri" Di Cremona
Cremona, Italy, 26100
Withdrawn
84
Istituto Europeo di Oncologia (IEO)
Milan, Italy, 20141
Actively Recruiting
85
Istituto Nazionale Tumori "Fondazione PASCALE"
Naples, Italy, 80131
Actively Recruiting
86
Azienda Ospedaliero-Universitaria Pisana
Pisa, Italy, 56124
Withdrawn
87
Ospedale Infermi di Rimini - Azienda Unita Sanitaria Locale Della Romagna
Rimini, Italy, 47923
Actively Recruiting
88
Centre Hospitalier De L'Ardenne
Libramont, Luxembourg, 06800
Actively Recruiting
89
Klinika Onkologii; Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy
Warsaw, Masovian Voivodeship, Poland, 04-141
Withdrawn
90
Przychodnia Lekarska "Komed" Roman Karaszewski
Konin, Poland, 62-500
Withdrawn
91
Instytut Centrum Zdrowia Matki Polki
Lodz, Poland, 93-338
Withdrawn
92
Med-Polonia Sp. Z o.o.
Poznan, Poland, 60-693
Withdrawn
93
Seoul National University Bundang Hospital
Seongnam-si, South Korea, 13620
Actively Recruiting
94
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
95
Gangnam Severance Hospital
Seoul, South Korea, 06273
Actively Recruiting
96
The Catholic University of Korea - Seoul St. Mary's Hospital
Seoul, South Korea, 06591
Withdrawn
97
Korea University Anam Hospital
Seoul, South Korea, 136-705
Withdrawn
98
Ulsan University Hospital
Ulsan, South Korea, 44033
Withdrawn
99
Complejo Hospitalario Universitario A Coruna
A Coruña, Spain, 15006
Actively Recruiting
100
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
101
Hospital Clinic Barcelona
Barcelona, Spain, 08036
Actively Recruiting
102
Hospital General Universitario Gregorio Maranon
Madrid, Spain, 28007
Actively Recruiting
103
IOB Madrd Institute of Oncology Hospital Beata Maria Ana de Jesus
Madrid, Spain, 28007
Actively Recruiting
104
Hospital Clinico San Carlos
Madrid, Spain, 28040
Actively Recruiting
105
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
106
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
107
Hospital Universitario Virgen de la Victoria
Málaga, Spain, 29010
Actively Recruiting
108
NEXT Madrid
Pozuelo de Alarcón, Spain, 28223
Actively Recruiting
109
Fundacion Instituto Valeciano De Oncologia
Valencia, Spain, 46009
Actively Recruiting
110
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
111
Hospital Arnau De Vilanova
Valencia, Spain, 46015
Actively Recruiting
112
Abdurrahman Yurtaslan Oncology Hospital
Ankara, Turkey (Türkiye), 0*6200
Actively Recruiting
113
Ankara Bilkent City Hospital, Bilkent Campus, Universiteler Mh. (old: Ankara Yildirim Beyazit Universitesi)
Ankara, Turkey (Türkiye), 6001CD
Withdrawn
114
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, United Kingdom, L7 8YA
Actively Recruiting
115
Liverpool Hospital
Liverpool, United Kingdom, NSW 2170
Withdrawn
116
North Middlesex University Hospital
London, United Kingdom, N18 1QX
Actively Recruiting
117
Sarah Cannon Research Institute UK; Ltd
London, United Kingdom, W1G 6AD
Actively Recruiting
118
University College London Hospitals NHS Foundation Trust; The London Clinic - Main Hospital
London, United Kingdom, W1T 7HA
Actively Recruiting
Research Team
S
Stemline Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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