RECRUITING

Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)

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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 and CDK4/6 Inhibitors for the treatment of patients with locally advanced or metastatic HR+/HER2- advanced breast cancer.

Official Title

VIKTORIA-2: A Randomized, Open-Label, Phase 3 Study of Fulvestrant and CDK4/6 Inhibitors With or Without Gedatolisib as First-Line Treatment in Patients With HR-Positive and HER2-Negative Advanced Breast Cancer

Quick Facts

Study Start:2025-06-30
Study Completion:2028-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06757634

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 HR+/HER2- breast cancer
  2. 2. 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 for the duration of the study.
  3. 3. Negative pregnancy test for females of childbearing potential. Female subjects who are not surgically sterile must use a medically effective contraceptive method from screening until 2 years after the last dose of study treatment.
  4. 4. Progression of disease during or within 12 months of completing (neo)adjuvant ET.
  5. 5. Adequate archival, fresh tumor tissue, or liquid biopsy for the analysis of PIK3CA mutational status.
  6. 6. Permitted prior therapies:
  7. 1. (neo)adjuvant fulvestrant or any selective ER degrader only if the treatment duration \< 6 months
  8. 2. (neo)adjuvant chemotherapy
  9. 3. (neo)adjuvant CDK4/6 inhibitor, unless PD was on or within 6 months of discontinuation of CDK4/6i
  10. 7. Subject has radiologically measurable disease according to RECIST v1.1, per local assessment. Patients with evaluable bone-only disease are not eligible. Patients with bone-only disease that has lytic or mixed lytic/blastic lesions and at least one measurable soft tissue component per RECIST v1.1 may be eligible.
  11. 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  12. 9. Life expectancy of at least \>6 months.
  13. 10. Adequate bone marrow, hepatic, renal and coagulation function.
  1. 1. Concurrent malignancies other than adequately treated non-melanoma skin cancer. Previous malignancies in remission but curatively treated with no evidence of disease progression and judged by local Investigator to be at low risk of impacting health or survival while on study.
  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 systemic anticancer therapy for ABC
  4. 4. Subjects with type 1 diabetes
  5. 5. Known and untreated, or active, brain or leptomeningeal metastases
  6. 6. History of clinically significant cardiovascular abnormalities
  7. 7. History of drug-induced symptomatic interstitial lung disease (pneumonitis) or hepatitis

Contacts and Locations

Study Contact

Nadene Zack, MS
CONTACT
844-310-3900
viktoria-2_eligibility@celcuity.com

Study Locations (Sites)

Providence Medical Foundation
Fullerton, California, 92835
United States
UCLA Hematology Oncology Ventura
Los Angeles, California, 93003
United States
The University of Kansas Cancer Center
Westwood, Kansas, 66205
United States
Mercy Health-Paducah Cancer Center
Paducah, Kentucky, 42003
United States
American Oncology Partners, P.A.
Bethesda, Maryland, 20817
United States
Henry Ford Health System
Detroit, Michigan, 48202
United States
Saint Luke's Cancer Institute
Kansas City, Missouri, 64111-5965
United States
Washington University School of Medicine in Saint Louis
Saint Louis, Missouri, 63110
United States
SCL Health - Cancer Centers of Montana
Billings, Montana, 59102
United States
Weill Cornell Medical College - NewYork-Presbyterian Hospital
New York, New York, 10065
United States
University of Rochester Medical Center (URMC) - James P. Wilmot Cancer Center - Pluta Cancer Center (PCC)
Rochester, New York, 14467
United States
Clinical Research Alliance, Inc.
Westbury, New York, 11590
United States
Stefanie Spielman Comprehensive Breast Center at Olentangy River Road
Columbus, Ohio, 43210
United States
Rittenhouse Hematology/Oncology
Philadelphia, Pennsylvania, 19004
United States
Sanford Health
Sioux Falls, South Dakota, 57104
United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4000
United States
Mays Cancer Center
San Antonio, Texas, 63110
United States
Bon Secours St. Francis Medical Oncology Center
Midlothian, Virginia, 23114-3203
United States

Collaborators and Investigators

Sponsor: 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 Date2025-06-30
Study Completion Date2028-12-30

Study Record Updates

Study Start Date2025-06-30
Study Completion Date2028-12-30

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