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Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)
701 patients around the world
Available in Argentina, Mexico, United States, Brazil, Spain
This is a Phase 3, open-label, randomized clinical trial evaluating the efficacy and
safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of
patients with advanced (inoperable) or metastatic Hormone Receptor Positive, Human
Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) breast cancer following
progression on or after CDK4/6 and aromatase inhibitor therapy. Gedatolisib is an
intravenously administered pan-PI3K/mTOR inhibitor. Palbociclib is a CDK4/6 inhibitor.
Fulvestrant is a selective estrogen receptor degrader (SERD). Subjects will be assessed
for PIK3CA status and then randomized to treatment arms according to their confirmed
PIK3CA mutation status.
Celcuity, Inc.
22Research sites
701Patients around the world
This study is for people with
Breast Cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Histologically or cytologically confirmed diagnosis of metastatic or locally advanced breast cancer Adult females, pre- and/or post-menopausal, and adult males. Pre-menopausal (and peri-menopausal) women can be enrolled if amenable to treatment with an LHRH agonist. Patients are to have commenced concomitant treatment with LHRH agonist prior to or on Cycle 1, Day 1 and must be willing to continue on it for the duration of the study.Negative pregnancy test for women of childbearing potential. Female subjects of childbearing potential must use an effective and/or acceptable contraceptive method from screening until 1 year after the last dose of study treatmentConfirmed diagnosis of estrogen receptor positive and/or progesterone receptor positive, as per American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) guidelines (2020), based on most recent tumor biopsy utilizing an assay consistent with local standardsDocumented HER2 immunohistochemistry (IHC) negative as per ASCO-CAP 2018 guidanceAdequate archival or fresh tumor tissue for the analysis of PIK3CA mutational statusSubject must have documentation of radiological disease progression on or after the last prior treatment and also have radiologically evaluable disease (measurable and/or non-measurable) according to RECIST v1.1, per local assessment. Subjects with bone only disease must have lytic or mixed lytic/blastic lesions that can be accurately assessed; bone only blastic lesions with no soft tissue component is not allowed.Eastern Cooperative Oncology Group (ECOG) performance status of 0-1Life expectancy of at least 3 monthsProgressed during or after CDK4/6 inhibitor combination treatment with non-steroidal aromatase inhibitor (AI)Adequate bone marrow, hepatic, renal and coagulation function
- History of malignancies other than adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥3 yearsPrior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor, a protein kinase B (Akt) inhibitor, or a mechanistic target of rapamycin (mTOR) inhibitorPrior treatment with chemotherapy and antibody drug conjugates for advanced disease is not permitted (prior adjuvant or neoadjuvant chemotherapy is permitted)More than 2 lines of prior endocrine therapy treatmentBone only disease that is only blastic with no soft tissue componentSubjects with type 1 diabetes or uncontrolled type 2 diabetesKnown and untreated, or active, brain or leptomeningeal metastasesa. Subjects with previously treated central nervous system (CNS) metastases may be enrolled in the study if they meet the following criteria: do not require supportive therapy with steroids; do not have seizures and do not exhibit uncontrolled neurological symptoms; stable disease confirmed by radiographic assessment within at least 4 weeks prior to enrollmentPatients with advanced, symptomatic, visceral spread that are at risk of life-threatening complication in the short-termHistory of clinically significant cardiovascular abnormalities such as: Congestive heart failure (New York Heart Association (NYHA) classification ≥ II within 6 months of study entryMyocardial infarction within 12 months of study entryHistory of any uncontrolled (or untreated) clinically significant cardiac arrhythmias, (e.g., ventricular tachycardia), complete left bundle branch block, high grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block), supraventricular, nodal arrhythmias, or conduction abnormality in the previous 12 monthsUncontrolled hypertension defined by systolic blood pressure (SBP) ≥160 mmHg and/or diastolic blood pressure (DBP) ≥100 mmHg, with or without antihypertensive medication (initiation or adjustment of antihypertensive medication[s] is allowed prior to screening)Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia, or history of clinically significant/symptomatic bradycardiaOn screening, inability to determine the corrected QT interval using Fridericia's formula (QTcF) on the ECG (i.e., unreadable or not interpretable) or QTcF >480 msec (determined by mean of triplicate ECGs at screening)Known hypersensitivity to the study drugs or their componentsPregnant or breast-feeding womenConcurrent participation in another interventional clinical trialSubjects must agree not to participate in another clinical trial (other than observational) at any time during participation in VIKTORIA-1.
Sites
Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan
Recruiting
Hospital Británico de Buenos Aires - CABA
Recruiting
Fundación Centro de Medicina Nuclear y Molecular Entre Ríos - CEMENER
Recruiting
Centro Médico Fleischer
Recruiting
Centro Médico Austral OMI - CABA
Recruiting
Fundación CENIT para la Investigación en Neurociencias
Recruiting
Centro de Diagnóstico Investigación y Tratamiento - CEDIT - Salta
Recruiting
Instituto Oncológico de Córdoba IONC - Fundación Richardet Longo
Recruiting
Pronutrir Nutrição
Recruiting
ONCOSITE - Centro de Pesquisa Clinica em Oncologia
Recruiting
StudyVIKTORIA-1
SponsorCelcuity, Inc.
Study typeInterventional
Conditions
Breast Cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05501886
