Overview

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)

Status:
Not yet recruiting
Trial end date:
2026-09-30
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Celcuity, Inc.
Treatments:
Fulvestrant
Gedatolisib
Palbociclib
Criteria
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 who are not surgically sterile. Female subjects who
are not surgically sterile must use a medically-effective 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 has radiologically evaluable disease (measurable and/or non-measurable)
according to RECIST v1.1, per local assessment. Mixed lytic/blastic or lytic lesions
with measurable soft tissue component are 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

Exclusion Criteria:

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. More than one prior treatment with chemotherapy for advanced disease (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 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, history of cardiac failure, or history of
clinically significant/symptomatic bradycardia

- ii. Concomitant medication(s) with a known risk to prolong the QT interval
and/or known to cause TdP that cannot be discontinued or replaced by safe
alternative medication

- iii. Bradycardia (heart rate <50 beats per minute at rest) by
electrocardiogram (ECG) or pulse

- iv. 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 >450 msec for males and >460 msec for females
(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 clinical trial

1. Subjects must agree not to participate in another clinical trial at any time
during participation in VIKTORIA-1.