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

Status: Recruiting
Location: See all (116) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

⁃ 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)

• 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.

• 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.

Locations
United States
Alabama
Dothan Hematology and Oncology
RECRUITING
Dothan
Arkansas
Highlands Oncology Group
RECRUITING
Springdale
Arizona
Mayo Clinic - Arizona
RECRUITING
Phoenix
California
OPN Healthcare (Arcadia Location)
RECRUITING
Arcadia
City of Hope National Medical Center
NOT_YET_RECRUITING
Duarte
Glendale Adventist
WITHDRAWN
Glendale
OPN Healthcare (Los Alamitos Location)
RECRUITING
Los Alamitos
Cedars Sinai
RECRUITING
Los Angeles
UCLA UCLA Hem/Onc - Clinical Research Unit
RECRUITING
Los Angeles
UCSF Helen Diller Family Comprehensive Cancer Center
RECRUITING
San Francisco
TOI Clinical Research
COMPLETED
Whittier
Colorado
Rocky Mountain Cancer Centers
RECRUITING
Lone Tree
Connecticut
Yale School Of Medicine - Smilow Cancer Hospital - Breast Center
WITHDRAWN
New Haven
Washington, D.c.
George Washington Cancer Center
RECRUITING
Washington D.c.
Florida
Advent Health (Florida Hospital) - Altamonte Springs
RECRUITING
Altamonte Springs
Mayo Clinic - Jacksonville
RECRUITING
Jacksonville
Ocala Oncology
RECRUITING
Ocala
Georgia
Northside Hospital Atlanta Cancer Care
WITHDRAWN
Cumming
Illinois
Northwestern Feinberg Scholl of Medicine Prentice Women's Hospital
RECRUITING
Chicago
Indiana
Fort Wayne Medical Oncology and Hematology
WITHDRAWN
Fort Wayne
Kansas
MD Alliance for Multispecialty Research, LLC
RECRUITING
Merriam
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Maryland
Johns Hopkins School of Medicine
RECRUITING
Baltimore
Maine
New England Cancer Specialists
WITHDRAWN
Scarborough
Michigan
Barbara Ann Karmanos Cancer Institute
RECRUITING
Detroit
Minnesota
Minnesota Oncology Hematology
WITHDRAWN
Minneapolis
Mayo Clinic - Rochester
RECRUITING
Rochester
Missouri
Washington University School of Medicine in St. Louis
RECRUITING
St Louis
New Jersey
Astera Cancer Care
RECRUITING
East Brunswick
Summit Medical Group
RECRUITING
Florham Park
Cooperman Barnabas Medical Center
RECRUITING
New Brunswick
New York
NYU Langone Health
RECRUITING
New York
New York Cancer and Blood Specialists
RECRUITING
Port Jefferson Station
Rhode Island
W&IH of RI Breast Health Center of Women and Infants Hospital of Rhode Island
RECRUITING
Providence
Tennessee
Sarah Cannon Research Institute / Tennessee Oncology
RECRUITING
Nashville
Texas
Texas Oncology - Baylor Charles A. Sammons Cancer Center
RECRUITING
Dallas
MD Anderson Cancer Center Texas
RECRUITING
Houston
UT Health San Antonio
RECRUITING
San Antonio
Virginia
Inova Schar Cancer Institute
RECRUITING
Fairfax
Virginia Cancer Specialists
RECRUITING
Fairfax
Virginia Oncology Associates
RECRUITING
Norfolk
Washington
Cancer Care Northwest
RECRUITING
Spokane Valley
Northwest Medical Specialties (Nwms) - Puyallup - Medical Oncology (Rainier Hematology-Oncology)/Exigent Research Network; LLC
RECRUITING
Tacoma
Wisconsin
University of WI - Carbone Cancer Center (Phase II only)
RECRUITING
Madison
Other Locations
Argentina
Centro Medico Austral
RECRUITING
Buenos Aires
Hospital Britanico De Buenos Aires
WITHDRAWN
Buenos Aires
Cemaic - Centro De Especialidades Medicas Ambulatorias E Investigacion Clinica
RECRUITING
Córdoba
Centro Oncologico Riojano Integral (Cori)
RECRUITING
La Rioja
Australia
Macquarie University
RECRUITING
Sydney
Belgium
Institut Jules Bordet
RECRUITING
Anderlecht
Grand Hôpital de Charleroi - Site Notre Dame
RECRUITING
Charleroi
Universitaire Ziekenhuizen (Uz) Leuven - Campus Gasthuisberg - Multidisciplinair Borstcentrum (Multidisciplinary Breast Center) (Mbc)
RECRUITING
Leuven
Algemeen Ziekenhuis Nikolaas; VITAZ; Oncologie Klinisch Studiecentrum
WITHDRAWN
Sint-niklaas
Brazil
ACCG - Hospital Araujo Jorge
RECRUITING
Goiânia
Clinica Neoplasias Litoral
RECRUITING
Itajaí
Centro Gaucho Integrado de Oncologia; Hematologia; Ensino e Pesquisa - Hospital Mae de Deus/AESC
RECRUITING
Porto Alegre
Hospital Sao Lucas da PUCRS
RECRUITING
Porto Alegre
Hospital Sirio-Libanes (HSL) - Centro De Oncologia - Sao Paulo
RECRUITING
São Paulo
France
Centre Hospitalier Lyon SUD- HCL
RECRUITING
Lyon
Centre de Cancérologie du Grand Montpellier
RECRUITING
Montpellier
Centre de Cancérologie du Grand Montpellier
RECRUITING
Rouen
Centre Hospitalier Universitaire (Chu) De Toulouse - Institut Universitaire Du Cancer De Toulouse-Oncopole (Iuct-Oncopole) (Institut Claudius Regaud)
RECRUITING
Toulouse
Institut Gustave-Roussy-Umr 981
RECRUITING
Villejuif
Germany
Marienhospital Bottrop
WITHDRAWN
Bottrop
Universitatskinikum Carl Gustav Carus Dresden
WITHDRAWN
Dresden
Universitatskinikum Carl Gustav Carus Dresden
WITHDRAWN
Dresden
Kliniken Essen-Mitte (KEM)
WITHDRAWN
Essen
Gesundheit Nordhessen Klinikum Kassel
WITHDRAWN
Kassel
Universitaetsklinikum Mannheim
RECRUITING
Mannheim
Technischen Universitaet Muenchen (TUM), Klinikum Rechts der Isar
WITHDRAWN
Munich
Universitaetsklinikum Tuebingen
WITHDRAWN
Tübingen
Hungary
Orszagos Onkologiai Intezet
WITHDRAWN
Budapest
Semmelweis Egyetem Klinikai Kozpont - Onkologiai Intezet
WITHDRAWN
Budapest
Israel
Samson Assuta Ashdod University Hospital - The Institute of Oncology
RECRUITING
Ashdod
Rambam Heath
RECRUITING
Haifa
Shaare Zedek Medical Center
RECRUITING
Jerusalem
Davidoff Rabin Medical Center
RECRUITING
Petah Tikva
Sheba Medical Center; Center Israel
RECRUITING
Ramat Gan
Italy
ASST degli Spedali Civili di Brescia
RECRUITING
Brescia
Azienda Ospedaliera Istituti Ospitalieri Di Cremona
WITHDRAWN
Cremona
Istituto Europeo di Oncologia (IEO)
RECRUITING
Milan
Istituto Nazionale Tumori Fondazione PASCALE
RECRUITING
Napoli
Azienda Ospedaliero-Universitaria Pisana
WITHDRAWN
Pisa
Ospedale Infermi di Rimini - Azienda Unita Sanitaria Locale Della Romagna
RECRUITING
Rimini
Luxembourg
Centre Hospitalier De L'Ardenne
RECRUITING
Libramont
Poland
Przychodnia Lekarska Komed Roman Karaszewski
WITHDRAWN
Konin
Instytut Centrum Zdrowia Matki Polki
WITHDRAWN
Lodz
Med-Polonia Sp. Z o.o.
WITHDRAWN
Poznan
Klinika Onkologii; Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy
WITHDRAWN
Warsaw
Republic of Korea
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Asan Medical Center
RECRUITING
Seoul
Gangnam Severance Hospital
RECRUITING
Seoul
Korea University Anam Hospital
WITHDRAWN
Seoul
The Catholic University of Korea - Seoul St. Mary's Hospital
WITHDRAWN
Seoul
Ulsan University Hospital
WITHDRAWN
Ulsan
Spain
Complejo Hospitalario Universitario A Coruna
RECRUITING
A Coruña
Hospital Clinic Barcelona
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Hospital Clinico San Carlos
RECRUITING
Madrid
Hospital General Universitario Gregorio Maranon
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
IOB Madrd Institute of Oncology Hospital Beata Maria Ana de Jesus
RECRUITING
Madrid
Hospital Universitario Virgen de la Victoria
RECRUITING
Málaga
NEXT Madrid
RECRUITING
Pozuelo De Alarcón
Fundacion Instituto Valeciano De Oncologia
RECRUITING
Valencia
Hospital Arnau De Vilanova
RECRUITING
Valencia
Hospital Clinico Universitario de Valencia
RECRUITING
Valencia
Turkey
Abdurrahman Yurtaslan Oncology Hospital
RECRUITING
Ankara
Ankara Bilkent City Hospital, Bilkent Campus, Universiteler Mh. (old: Ankara Yildirim Beyazit Universitesi)
WITHDRAWN
Ankara
United Kingdom
Liverpool Hospital
WITHDRAWN
Liverpool
The Clatterbridge Cancer Centre NHS Foundation Trust
RECRUITING
Liverpool
North Middlesex University Hospital
RECRUITING
London
Sarah Cannon Research Institute UK; Ltd
RECRUITING
London
University College London Hospitals NHS Foundation Trust; The London Clinic - Main Hospital
RECRUITING
London
Contact Information
Primary
Stemline Trials
clinicaltrials@menarinistemline.com
1-877-332-7961
Time Frame
Start Date: 2023-01-24
Estimated Completion Date: 2028-12-28
Participants
Target number of participants: 435
Treatments
Experimental: Phase 1b Arm A: elacestrant with alpelisib
Elacestrant Dihydrochloride 300 milligrams (mg) or 400 mg + Alpelisib 150 mg to 250 mg
Experimental: 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
Experimental: 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)
Experimental: 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
Experimental: Phase 1b Arm E:
Elacestrant Dihydrochloride 300 mg, 400 mg + Capivasertib 200 mg, 320 mg, 400 mg
Related Therapeutic Areas
Sponsors
Leads: Stemline Therapeutics, Inc.

This content was sourced from clinicaltrials.gov