Last updated 16 months ago

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 treatment
Confirmed 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 standards
Documented HER2 immunohistochemistry (IHC) negative as per ASCO-CAP 2018 guidance
Adequate archival or fresh tumor tissue for the analysis of PIK3CA mutational status
Subject 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 0-1
Life expectancy of at least 3 months
Progressed 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 years
Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor, a protein kinase B (Akt) inhibitor, or a mechanistic target of rapamycin (mTOR) inhibitor
Prior 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 treatment
Bone only disease that is only blastic with no soft tissue component
Subjects with type 1 diabetes or uncontrolled type 2 diabetes
Known and untreated, or active, brain or leptomeningeal metastases
a. 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 enrollment
Patients with advanced, symptomatic, visceral spread that are at risk of life-threatening complication in the short-term
History of clinically significant cardiovascular abnormalities such as: Congestive heart failure (New York Heart Association (NYHA) classification ≥ II within 6 months of study entry
Myocardial infarction within 12 months of study entry
History 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 months
Uncontrolled 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 bradycardia
On 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 components
Pregnant or breast-feeding women
Concurrent participation in another interventional clinical trial
Subjects 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

Laprida 532 Este, San Juan

Hospital Británico de Buenos Aires - CABA

Recruiting

Perdriel 74, CABA, Buenos Aires

Fundación Centro de Medicina Nuclear y Molecular Entre Ríos - CEMENER

Recruiting

Camino De La Cuchilla 595, Oro Verde, Entre Ríos

Centro Médico Fleischer

Recruiting

CABA, C1414

Centro Médico Austral OMI - CABA

Recruiting

Montevideo 955, C1019ABS Cdad. Autónoma de Buenos Aires, Argentina

Fundación CENIT para la Investigación en Neurociencias

Recruiting

Juncal 2222, C1125 CABA, Argentina

Centro de Diagnóstico Investigación y Tratamiento - CEDIT - Salta

Recruiting

Santiago del Estero 1415, Salta Capital

Instituto Oncológico de Córdoba IONC - Fundación Richardet Longo

Recruiting

Paraná 560, Córdoba

Pronutrir Nutrição

Recruiting

Rua Padre Valdevino, 778 - Aldeota, Fortaleza - CE, 60135-040

ONCOSITE - Centro de Pesquisa Clinica em Oncologia

Recruiting

Ijui, 98700-000

StudyVIKTORIA-1

SponsorCelcuity, Inc.

Study typeInterventional

Conditions

Breast Cancer

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT05501886