Informations générales (source: ClinicalTrials.gov)
Phase 3, Open-Label, Randomized, Study Comparing Gedatolisib Combined With Fulvestrant & With or Without Palbociclib to Standard-of-Care Therapies in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination w/Non-Steroidal Aromatase Inhibitor Therapy (VIKTORIA-1)
Interventional
Phase 3
Celcuity Inc (Voir sur ClinicalTrials)
décembre 2022
décembre 2026
05 avril 2025
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 locally advanced or metastatic HR+/HER2- breast cancer following
progression on or after CDK4/6 and aromatase inhibitor therapy.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Barbara PISTILLI | 19/06/2024 12:33:58 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Bergonie Institute - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| CHU La Timone - La Timone Children's Hospital - Marseille - France | Contact (sur clinicalTrials) | ||||
| Francois Baclesse Center - 14076 - Caen - France | Contact (sur clinicalTrials) | ||||
| Gustave Roussy - Villejuif - France | Contact (sur clinicalTrials) | ||||
| La Roche-sur-Yon Hospital - 85925 - La Roche-sur-Yon - France | Contact (sur clinicalTrials) | ||||
| Saint Anne Clinic - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| University Hospital Center of Poitiers - Poitiers - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. 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.
2. 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
3. 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
4. Documented HER2 immunohistochemistry (IHC) negative as per ASCO-CAP 2018 guidance
5. Adequate archival or fresh tumor tissue for the analysis of PIK3CA mutational status
6. 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.
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
8. Life expectancy of at least 3 months
9. Progressed during or after CDK4/6 inhibitor combination treatment with non-steroidal
aromatase inhibitor (AI)
10. Adequate bone marrow, hepatic, renal and coagulation function
1. 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.
2. 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
3. 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
4. Documented HER2 immunohistochemistry (IHC) negative as per ASCO-CAP 2018 guidance
5. Adequate archival or fresh tumor tissue for the analysis of PIK3CA mutational status
6. 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.
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
8. Life expectancy of at least 3 months
9. Progressed during or after CDK4/6 inhibitor combination treatment with non-steroidal
aromatase inhibitor (AI)
10. Adequate bone marrow, hepatic, renal and coagulation function
1. 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
2. Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor, a protein kinase
B (Akt) inhibitor, or a mechanistic target of rapamycin (mTOR) inhibitor
3. Prior treatment with chemotherapy and antibody drug conjugates for advanced disease
is not permitted (prior adjuvant or neoadjuvant chemotherapy is permitted)
4. More than 2 lines of prior endocrine therapy treatment
5. Bone only disease that is only blastic with no soft tissue component
6. Subjects with type 1 diabetes or uncontrolled type 2 diabetes
7. 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
8. Patients with advanced, symptomatic, visceral spread that are at risk of
life-threatening complication in the short-term
9. History of clinically significant cardiovascular abnormalities such as: Congestive
heart failure (New York Heart Association (NYHA) classification ≥ II within 6 months
of study entry
1. Myocardial infarction within 12 months of study entry
2. 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
3. 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)
4. Long QT syndrome, family history of idiopathic sudden death or congenital long
QT syndrome, or any of the following:
- i. Risk factors for Torsades de Pointes (TdP) including uncorrected
hypokalemia or hypomagnesemia, or history of clinically
significant/symptomatic bradycardia
- ii. 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)
10. Known hypersensitivity to the study drugs or their components
11. Pregnant or breast-feeding women
12. Concurrent participation in another interventional clinical trial
1. Subjects must agree not to participate in another clinical trial (other than
observational) at any time during participation in VIKTORIA-1.