RECRUITING

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)

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Conditions

Breast CancerBreast Cancer, Advanced or MetastaticgedatolisibHR PositiveER PositiveHER2 NegativePIK3CA MTPI3K

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-09-30
Study Completion:2026-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05501886

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 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. 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. 4. Documented HER2 immunohistochemistry (IHC) negative as per ASCO-CAP 2018 guidance
  5. 5. Adequate archival or fresh tumor tissue for the analysis of PIK3CA mutational status
  6. 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. 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  8. 8. Life expectancy of at least 3 months
  9. 9. Progressed during or after CDK4/6 inhibitor combination treatment with non-steroidal aromatase inhibitor (AI)
  10. 10. Adequate bone marrow, hepatic, renal and coagulation function
  1. 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. 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. 3. Prior treatment with chemotherapy and antibody drug conjugates for advanced disease is not permitted (prior adjuvant or neoadjuvant chemotherapy is permitted)
  4. 4. More than 2 lines of prior endocrine therapy treatment
  5. 5. Bone only disease that is only blastic with no soft tissue component
  6. 6. Subjects with type 1 diabetes or uncontrolled type 2 diabetes
  7. 7. Known and untreated, or active, brain or leptomeningeal metastases
  8. 8. Patients with advanced, symptomatic, visceral spread that are at risk of life-threatening complication in the short-term
  9. 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
  10. 1. Myocardial infarction within 12 months of study entry
  11. 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
  12. 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)
  13. 4. Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
  14. * i. Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia, or history of clinically significant/symptomatic bradycardia
  15. * 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)
  16. 10. Known hypersensitivity to the study drugs or their components
  17. 11. Pregnant or breast-feeding women
  18. 12. Concurrent participation in another interventional clinical trial
  19. 1. Subjects must agree not to participate in another clinical trial (other than observational) at any time during participation in VIKTORIA-1.

Contacts and Locations

Study Contact

Nadene Zack, MS
CONTACT
844-310-3900
VIKTORIA-1_TRIAL@CELCUITY.COM

Principal Investigator

Nadene Zack
STUDY_DIRECTOR
Celcuity Inc

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Arizona Oncology (US Oncology/McKesson) - Goodyear
Goodyear, Arizona, 85395
United States
St. Bernards Medical Center
Jonesboro, Arkansas, 72401
United States
CARTI Cancer Center
Little Rock, Arkansas, 72205
United States
Pacific Cancer Medical Center Inc
Anaheim, California, 92801
United States
Kaiser Permanente South Bay Medical Center
Harbor City, California, 90710
United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, 90720
United States
Pacific Cancer Care
Monterey, California, 93940
United States
University of California, Irvine Medical Center
Orange, California, 92868
United States
Ventura County Hematology Oncology Specialists
Oxnard, California, 93030
United States
Redlands Hematology Oncology
Redlands, California, 92373
United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158
United States
UCLA Hematology/Oncology-Santa Monica
Santa Monica, California, 90904
United States
Torrance Memorial Physician Network - Cancer Care
Torrance, California, 90505
United States
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, 94589
United States
PIH Health Hospital Whittier
Whittier, California, 90602-1006
United States
Yale Cancer Center - New Haven
New Haven, Connecticut, 06520-8028
United States
South Broward Hospital District d/b/a Memorial Healthcare System
Hollywood, Florida, 33021
United States
Cancer Specialists of North Florida - Jacksonville
Jacksonville, Florida, 32256
United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
United States
Bond & Steele Clinic, P.A. d/b/a Bond Clinic, P.A.
Winter Haven, Florida, 33881
United States
John D. Archbold Memorial Hospital
Thomasville, Georgia, 31792
United States
Illinois Cancer Specialists - Arlington Heights
Arlington Heights, Illinois, 60005
United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46845
United States
University of Kentucky Medical Center
Lexington, Kentucky, 40536-0293
United States
Mercy Health - Paducah
Paducah, Kentucky, 42003
United States
American Oncology Partners of Maryland, PA
Bethesda, Maryland, 20817-7847
United States
Maryland Oncology Hematology, P.A. - Rockville
Rockville, Maryland, 20850
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215-5450
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Nebraska Hematology - Oncology, P.C.
Lincoln, Nebraska, 68506
United States
Oncology Hematology West PC dba Nebraska Cancer Specialists
Omaha, Nebraska, 68130
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States
New York Oncology Hematology, P.C. - Albany
Albany, New York, 12206
United States
Montefiore Medical Center
Bronx, New York, 10467
United States
Queens Hospital Cancer Center
Jamaica, New York, 11432
United States
Coleman, Pasmantier & Decter, MDs
New York, New York, 10021-5302
United States
Weill Cornell Medicine/New York-Presbyterian Hospital
New York, New York, 10021
United States
University of Rochester Medical Center
Rochester, New York, 14642
United States
Hematology/Oncology Associates of Central New York
Syracuse, New York, 13057
United States
White Plains Hospital
White Plains, New York, 10601
United States
Cone Health Cancer Center at Alamance Regional, Hematology/Oncology
Greensboro, North Carolina, 27403
United States
Southeast Regional Cancer Center
Lumberton, North Carolina, 28359
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106-1716
United States
The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, 43210
United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
United States
Oregon Oncology Specialists
Salem, Oregon, 97301
United States
Northwest Cancer Specialists, PC - Tigard
Tigard, Oregon, 97223
United States
Consultants In Medical Oncology and Hematology, P.C.
Broomall, Pennsylvania, 19008
United States
Alliance Cancer Specialists PC
Horsham, Pennsylvania, 19044
United States
Cancer Care Associates of York
York, Pennsylvania, 17403
United States
Sanford Gynecologic Oncology Clinic
Sioux Falls, South Dakota, 57104
United States
Texas Oncology - Austin
Austin, Texas, 78745
United States
Texas Oncology P.A. - Dallas
Dallas, Texas, 75230
United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
United States
William Beaumont Army Medical Center
El Paso, Texas, 79920
United States
Oncology Consultants
Houston, Texas, 77030
United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
Brooke Army Medical Center
Houston, Texas, 78234
United States
Texas Oncology - McKinney
McKinney, Texas, 75071
United States
Texas Oncology - Gulf Coast
Sugar Land, Texas, 77479
United States
Texas Oncology - Tyler
Tyler, Texas, 75702
United States
Fort Belvoir Community Hospital
Fort Belvoir, Virginia, 22060
United States
Bon Secours St. Francis Medical Oncology Center
Midlothian, Virginia, 23114
United States
Virginia Oncology Associates - Newport News
Newport News, Virginia, 23502
United States
VCU Massey Cancer Center
Richmond, Virginia, 23219
United States
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care - Roanoke
Roanoke, Virginia, 24014
United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109-1023
United States
Northwest Medical Specialties, PLLC - Tacoma
Tacoma, Washington, 98405
United States

Collaborators and Investigators

Sponsor: Celcuity Inc

  • Nadene Zack, STUDY_DIRECTOR, Celcuity Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-30
Study Completion Date2026-09-30

Study Record Updates

Study Start Date2022-09-30
Study Completion Date2026-09-30

Terms related to this study

Keywords Provided by Researchers

  • Breast Cancer, Advanced or Metastatic
  • gedatolisib
  • HR Positive
  • ER Positive
  • HER2 Negative
  • PIK3CA MT
  • PI3K

Additional Relevant MeSH Terms

  • Breast Cancer