Trial Title:
ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study
NCT ID:
NCT05596409
Condition:
Metastatic Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
metastatic breast cancer
breast cancer
elacestrant
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Elacestrant
Description:
Starting dose 400 mg elacestrant dihydrochloride administered orally once daily for an
estimated 6 months of treatment.
Arm group label:
Elacestrant
Summary:
The purpose of this study is to evaluate the efficacy and safety of elacestrant over the
course of 6 months in patients with estrogen receptor positive (ER+)/human epidermal
growth factor receptor-2 negative (HER2-) advanced/metastatic breast cancer who received
no prior cyclin-dependent kinase targeting enzymes CDK4 and CDK6 inhibitor (CDK4/6i) in
the metastatic setting.
Detailed description:
This is a Phase 2 trial evaluating the efficacy of elacestrant in patients with ER+/HER2-
advanced/metastatic breast cancer who received one or two prior hormonal therapies and no
prior CDK4/6i in the metastatic setting.
The study duration for each patient is estimated to be:
- Screening Phase: Up to 28 days prior to Cycle 1, Day 1 (C1D1);
- Treatment Phase: From C1D1 until the date of radiologically documented progression,
or treatment discontinuation due to other reasons.
- Survival Follow-Up Phase: All patients will be followed for survival approximately
every 3 months up to 24 months after enrollment of the last patient.
Patients will be followed for adverse events (AEs) for 28 days after the last treatment
administration.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patient 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 as per local law), at the
time of informed consent signature. Female patients may be either postmenopausal or
premenopausal/perimenopausal.
1. Premenopausal or perimenopausal women and men must be concurrently given a
luteinizing hormone-releasing hormone (LHRH) agonist starting at least 4 weeks
before the start of trial therapy and is planning to continue LHRH during the
study.
2. For perimenopausal women to be considered of non-childbearing potential,
follicle-stimulating hormone (FSH) levels must be >40 milli-international units
per milliliter (mIU/mL).
3. Documentation of histopathologically or cytologically confirmed ER+, HER2-breast
cancer, per local laboratory, as per the American Society of Clinical Oncology
(ASCO)/College of American Pathologists (CAP) 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.
4. Radiological disease progression during or after the most recent therapy in the
advanced/metastatic setting
5. Patient has received at least one (and up to two) prior hormonal therapy in the
advanced/metastatic setting.
6. Patients with disease relapse while on adjuvant endocrine therapy after the 2 first
years, or with disease relapse within 12 months of completing adjuvant endocrine
therapy are allowed (i.e., patients with secondary-resistant breast cancer according
to the 5th European School of Oncology (ESO)-European Society for Medical Oncology
(ESMO) international consensus guidelines for advanced breast cancer, Cardoso et al
2020). This therapy will be considered as first line treatment for eligibility
purposes.
7. At least one measurable lesion as per Response Evaluation Criteria in Solid Tumors
(RECIST) version 1.1 or a mainly lytic bone lesion for bone only disease.
8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
9. Patient has adequate bone marrow and organ function, as defined by the following
laboratory values:
1. Absolute neutrophil count (ANC) ≥1.5 × 10^9/liter(L)
2. Platelets ≥100 × 10^9/L
3. Hemoglobin ≥9.0 grams(g)/deciliter(dL)
4. Potassium, sodium, calcium (corrected for serum albumin) and magnesium, Common
Terminology Criteria for Adverse Events (CTCAE) v5.0 grade ≤1. Note: Corrected
calcium for serum albumin must be calculated manually by the site using the
Payne formula: Corrected calcium (milligrams [mg]/dL) = measured total calcium
(mg/dL) + 0.8 (Normal albumin [g/dL] - serum albumin [g/dL]), where normal
albumin is usually defaulted to 4.0 g/dL.
5. Cockcroft-Gault based creatinine clearance ≥50 milliliters per minute (mL/min).
Note: Creatinine clearance (male) = ([140-age in years] × weight in kilograms
[kg])/ ([serum creatinine in mg/dL] × 72) Creatinine clearance (female) = (0.85
× [140-age in years] × weight in kg)/ ([serum creatinine in mg/dL] × 72)
6. Serum albumin ≥3.0 g/dL (≥30 g/L)
7. In absence of liver metastases, alanine aminotransferase (ALT) and aspartate
aminotransferase (AST) ≤3.0 × upper limit of normal (ULN). If the patient has
liver metastases, ALT and AST ≤5 × ULN
8. If the patient has liver metastases, ALT, and AST ≤5.0 × ULN
9. Total serum bilirubin <1.5 × ULN except for patients with Gilbert's syndrome
who may be included if the total serum bilirubin is ≤3.0 × ULN or direct
bilirubin ≤ 1.5 × ULN. Note: Laboratory assessments may be repeated during the
Screening Phase after supplementation or transfusions (a single red blood cells
transfusion is allowed once during the screening period).
Exclusion Criteria:
1. Active or newly diagnosed central nervous system (CNS) metastases, including
meningeal carcinomatosis.
2. Patients with advanced, symptomatic visceral crisis who are at risk of
life-threatening complications in the short term, including massive uncontrolled
effusions (peritoneal, pleural, pericardial) and liver involvement of >50%.
3. Prior chemotherapy, elacestrant, or CDK4/6i in the advanced/metastatic setting.
4. Patients with only disease relapse while on the first 2 years of adjuvant endocrine
therapy i.e., patients with primary endocrine resistance, are not eligible.
5. Patient has a concurrent malignancy or history of invasive malignancy within 3 years
of enrollment, with the exception of basal or squamous cell skin cancer, superficial
bladder cancer, or carcinoma in situ of the cervix that has completed curative
treatment.
6. Uncontrolled significant active infections.
1. Patients with hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection
must have undetectable viral load during screening.
2. Patients known to be human immunodeficiency virus (HIV)+ are allowed as long as
they have undetectable viral load at baseline.
7. Major surgery within 28 days before starting trial therapy.
8. Systemic radiotherapy within 14 days before starting trial therapy, or central
nervous system (CNS) radiotherapy within 28 days before starting trial therapy.
Inability to take oral medication, refractory or chronic nausea, gastrointestinal
condition (including significant gastric or bowel resection), history of
malabsorption syndrome, or any other uncontrolled gastrointestinal condition that
may impact the absorption of study drug.
9. Known intolerance to elacestrant or any of its excipients.
10. Females of childbearing potential who do not agree to use a highly effective method
of contraception and to abstain from donating/freezing ova within 28 days of the
first dose of study treatment through 120 days after the last dose of study
treatment. Highly effective non-hormonal methods of contraception should be used.
11. Men who do not agree to abstain from donating/freezing sperm, or to use a highly
effective method of contraception within 28 days of the first dose of study
treatment through 120 days after the last dose of study treatment. For subjects (who
have not undergone vasectomy) with female partners of childbearing potential, the
subject and his partner must use highly effective methods of contraception.
12. Females who are pregnant or breastfeeding. Females should not get pregnant during
study treatment and for 120 days after last dose of study treatment. Females should
not breastfeed during administration of elacestrant and for 1 week after receiving
the last dose.
13. Patient is currently receiving or received any of the following medications prior to
first dose of trial therapy:
1. Investigational anti-cancer therapy within 14 days (28 days in case of
anticancer antibody-based treatments) or 5 half-lives, whichever is shorter.
2. Fulvestrant treatment (last injection) <42 days before first dose of study
drug.
3. Any other endocrine therapy <14 days before first dose of study drug.
4. Known strong or moderate inducers or inhibitors of cytochrome P450 (CYP) 3A4
within 14 days or 5 half-lives, whichever is shorter.
5. Herbal preparations/medications within 7 days. These include, but are not
limited to, St. John's wort, kava, ephedra (ma huang), gingko biloba,
dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng.
14. Any severe medical or psychiatric condition that in the opinion of the
investigator(s) would preclude the patient's participation in a clinical study
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Highlands Oncology Group, PA
Address:
City:
Springdale
Zip:
72762
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Thaddeus Beck
Email:
Principal Investigator
Facility:
Name:
OPN Healthcare
Address:
City:
Arcadia
Zip:
91007
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Anthony Lam
Email:
Principal Investigator
Facility:
Name:
University of Colorado Cancer Center
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Peter Kabos
Email:
Principal Investigator
Facility:
Name:
Morton Plant Hospital - Baycare Health System
Address:
City:
Clearwater
Zip:
33756
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Vijaya Gadiyaram
Email:
Principal Investigator
Facility:
Name:
Inventa Center for Cancer Research at Fort Wayne Medical Oncology and Hematology
Address:
City:
Fort Wayne
Zip:
46804
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Naga Vutukuri
Email:
Principal Investigator
Facility:
Name:
Alliance for Multispecialty Research
Address:
City:
Merriam
Zip:
66204
Country:
United States
Status:
Completed
Facility:
Name:
Comprehensive Cancer Centers of Nevada
Address:
City:
Las Vegas
Zip:
89128
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Anu Thummala
Email:
Principal Investigator
Facility:
Name:
The Toledo Clinic
Address:
City:
Toledo
Zip:
43606
Country:
United States
Status:
Completed
Facility:
Name:
UT Health San Antonio Mays Cancer Center
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Virginia Kaklamani
Email:
Principal Investigator
Facility:
Name:
Quality Cancer Care Alliance (QCCA) Northwest Medical Specialties
Address:
City:
Tacoma
Zip:
98405
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Sibel Blau
Email:
Principal Investigator
Facility:
Name:
Centro de Pesquisas Clinicas em Oncologia (Center for Clinical Research in Oncology (CPCO)) - Hospital Evangélico de Cachoeiro de Itapemirim
Address:
City:
Cachoeiro De Itapemirim
Zip:
29308-014
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Alexio Sabina
Email:
Principal Investigator
Facility:
Name:
Hospital São Lucas PUCRS - Centro de Pesquisa em Oncologia (CPO)
Address:
City:
Porto Alegre
Zip:
70200-730
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Carlos Barrios
Email:
Principal Investigator
Facility:
Name:
Hospital de Clinicas de Porto Alegre
Address:
City:
Porto Alegre
Zip:
90035
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Liedke Pedro
Email:
Principal Investigator
Facility:
Name:
Centro de Pesquisas Oncologicas
Address:
City:
Florianópolis
Zip:
88034-000
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Yeni Nerón
Email:
Principal Investigator
Facility:
Name:
Hospital de Amor de Barretos
Address:
City:
Barretos
Zip:
14784-400
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Augusto Perazzolo Antoniazzi
Email:
Principal Investigator
Facility:
Name:
Centro de Estudos e Pesquisas de Hematologia e Oncologia- CEPHO
Address:
City:
Santo Andre
Zip:
09060-650
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Patricia Santi
Email:
Principal Investigator
Facility:
Name:
Centro De Pesquisa Clinica DO Hospital Sirio-Libanes - UNIDADE Brasilia
Address:
City:
Brasília
Zip:
70200-730
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Strava Correa Tatianaw
Email:
Principal Investigator
Facility:
Name:
Clinica de Pesquisas e Centro de Estudos Em Oncologia Ginecologica e Mamaria Ltda
Address:
City:
São Paulo
Zip:
01317-001
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Roberto Hegg
Email:
Principal Investigator
Facility:
Name:
Complex Oncology Center
Address:
City:
Plovdiv
Zip:
4000
Country:
Bulgaria
Status:
Recruiting
Investigator:
Last name:
Antoaneta Tomova
Email:
Principal Investigator
Facility:
Name:
COMPLEX ONCOLOGICAL CENTER - Shumen
Address:
City:
Shumen
Zip:
9700
Country:
Bulgaria
Status:
Recruiting
Investigator:
Last name:
Nikolay Nikolov
Email:
Principal Investigator
Facility:
Name:
COC Veliko Tarnovo
Address:
City:
Veliko Tarnovo
Zip:
5000
Country:
Bulgaria
Status:
Recruiting
Investigator:
Last name:
Dora Zakova
Email:
Principal Investigator
Facility:
Name:
Cancer Research Centre
Address:
City:
Tbilisi
Zip:
179
Country:
Georgia
Status:
Recruiting
Investigator:
Last name:
Nia Sharikadze
Email:
Principal Investigator
Facility:
Name:
Innova Medical Center
Address:
City:
Tbilisi
Zip:
179
Country:
Georgia
Status:
Recruiting
Investigator:
Last name:
Mikheil Janjalia
Email:
Principal Investigator
Facility:
Name:
LTD Simon Khechinashvili University Clinic
Address:
City:
Tbilisi
Zip:
179
Country:
Georgia
Status:
Recruiting
Investigator:
Last name:
Giorgi Dzagnidze
Email:
Principal Investigator
Facility:
Name:
Multiprofile Clinic Consilium Medulla
Address:
City:
Tbilisi
Zip:
186
Country:
Georgia
Status:
Recruiting
Investigator:
Last name:
Lia Abshilava
Email:
Principal Investigator
Facility:
Name:
Institute of Clinical Oncology
Address:
City:
Tbilisi
Country:
Georgia
Status:
Recruiting
Investigator:
Last name:
Gia Nemsadze
Email:
Principal Investigator
Facility:
Name:
Todua Clinic
Address:
City:
Tbilisi
Country:
Georgia
Status:
Recruiting
Investigator:
Last name:
Tamar Melkadze
Email:
Principal Investigator
Facility:
Name:
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca
Address:
City:
Cluj Napoca
Zip:
400150
Country:
Romania
Status:
Recruiting
Investigator:
Last name:
Nicoleta Zenovia Antone
Email:
Principal Investigator
Facility:
Name:
Centrul de Oncologie "Sf. Nectarie"
Address:
City:
Craiova
Zip:
200542
Country:
Romania
Status:
Recruiting
Investigator:
Last name:
Michael Schenker
Email:
Principal Investigator
Start date:
May 19, 2023
Completion date:
August 2025
Lead sponsor:
Agency:
Stemline Therapeutics, Inc.
Agency class:
Other
Source:
Stemline Therapeutics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05596409
