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

Purpose

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.

Condition

  • Breast Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Histologically or cytologically confirmed diagnosis of metastatic or locally advanced HR+/HER2- breast cancer 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. 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. Progression of disease during or within 12 months of completing (neo)adjuvant ET. 5. Adequate archival, fresh tumor tissue, or liquid biopsy for the analysis of PIK3CA mutational status. 6. Permitted prior therapies: 1. (neo)adjuvant fulvestrant or any selective ER degrader only if the treatment duration < 6 months 2. (neo)adjuvant chemotherapy 3. (neo)adjuvant CDK4/6 inhibitor, unless PD was on or within 6 months of discontinuation of CDK4/6i 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. 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 9. Life expectancy of at least >6 months. 10. Adequate bone marrow, hepatic, renal and coagulation function.

Exclusion Criteria

  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. 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 systemic anticancer therapy for ABC 4. Subjects with type 1 diabetes 5. Known and untreated, or active, brain or leptomeningeal metastases 6. History of clinically significant cardiovascular abnormalities 7. History of drug-induced symptomatic interstitial lung disease (pneumonitis) or hepatitis

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A: Gedatolisib + Palbociclib or Ribociclib + Fulvestrant 		Drug: Gedatolisib Participants will receive intravenous (IV) gedatolisib once weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off
  • Drug: Arm A: Gedatolisib + Palbociclib or Ribociclib + Fulvestrant
    Drug: Gedatolisib Participants will receive intravenous (IV) gedatolisib once weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off Other Names: • PF-05212384 Drug: Palbociclib Participants will receive oral palbociclib on days 1-21 of each 28-day cycle. Other Names: • IBRANCE Drug: Ribociclib Participants will receive oral ribociclib on Days 1-21 of each 28-day cycle Other Names: • KISQALI® Drug: Fulvestrant Participants will receive intramuscular (IM) fulvestrant every 2 weeks during Cycle 1 and then every 4 weeks Other Names: • Faslodex
    Other names:
    • PF-05212384, IBRANCE, KISQALI®, Faslodex
  • Drug: Arm B: Palbociclib or Ribociclib + Fulvestrant
    Drug: Palbociclib Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle Other Names: • IBRANCE Drug: Ribociclib Participants will receive oral ribociclib on Days 1-21 of each 28-day cycle Other Names: • KISQALI® Drug: Fulvestrant Participants will receive intramuscular (IM) fulvestrant approximately every 2 weeks during Cycle 1 then approximately every 4 Other Names: • Faslodex
    Other names:
    • IBRANCE, KISQALI®, Faslodex
Active Comparator
Arm B: Palbociclib or Ribociclib + Fulvestrant 		Drug: Palbociclib Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle
  • Drug: Arm A: Gedatolisib + Palbociclib or Ribociclib + Fulvestrant
    Drug: Gedatolisib Participants will receive intravenous (IV) gedatolisib once weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off Other Names: • PF-05212384 Drug: Palbociclib Participants will receive oral palbociclib on days 1-21 of each 28-day cycle. Other Names: • IBRANCE Drug: Ribociclib Participants will receive oral ribociclib on Days 1-21 of each 28-day cycle Other Names: • KISQALI® Drug: Fulvestrant Participants will receive intramuscular (IM) fulvestrant every 2 weeks during Cycle 1 and then every 4 weeks Other Names: • Faslodex
    Other names:
    • PF-05212384, IBRANCE, KISQALI®, Faslodex
  • Drug: Arm B: Palbociclib or Ribociclib + Fulvestrant
    Drug: Palbociclib Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle Other Names: • IBRANCE Drug: Ribociclib Participants will receive oral ribociclib on Days 1-21 of each 28-day cycle Other Names: • KISQALI® Drug: Fulvestrant Participants will receive intramuscular (IM) fulvestrant approximately every 2 weeks during Cycle 1 then approximately every 4 Other Names: • Faslodex
    Other names:
    • IBRANCE, KISQALI®, Faslodex

Recruiting Locations

Providence Medical Foundation
Fullerton 5351247, California 5332921 92835

UCLA Hematology Oncology Santa Monica
Los Angeles 5368361, California 5332921 90404

BRCR Medical Center, Inc- Internal Medicine
Plantation 4168782, Florida 4155751 33322

BRCR Medical Center, INC
Tamarac 4174738, Florida 4155751 33321

The University of Kansas Cancer Center
Westwood 4281639, Kansas 4273857 66205

Mercy Health-Paducah Cancer Center
Paducah 4048662, Kentucky 6254925 42003

American Oncology Partners, P.A.
Bethesda 4348599, Maryland 4361885 20817

Henry Ford Health System
Detroit 4990729, Michigan 5001836 48202

Saint Luke's Cancer Institute
Kansas City 4393217, Missouri 4398678 64111-5965

Washington University School of Medicine in Saint Louis
St Louis 4407066, Missouri 4398678 63110

SCL Health - Cancer Centers of Montana
Billings 5640350, Montana 5667009 59102

Clinical Research Alliance, Inc.
Westbury 5144040, New York 5128638 11590

Stefanie Spielman Comprehensive Breast Center at Olentangy River Road
Columbus 4509177, Ohio 5165418 43210

Rittenhouse Hematology/Oncology
Philadelphia 4560349, Pennsylvania 6254927 19004

University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030-4000

Mays Cancer Center
San Antonio 4726206, Texas 4736286 78229

Bon Secours St. Francis Medical Oncology Center
Midlothian 4772943, Virginia 6254928 23114-3203

Fred Hutchinson Cancer Center
Seattle 5809844, Washington 5815135 98109

More Details

NCT ID
NCT06757634
Status
Recruiting
Sponsor
Celcuity Inc

Study Contact

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

Detailed Description

This is a Phase 3, open-label, randomized clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant combined with a CDK4/6 inhibitor (Investigator's choice of palbociclib or ribociclib) for the treatment of patients with advanced (inoperable) or metastatic hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+/HER2-) breast cancer whose disease has progressed during or within 12 months of adjuvant treatment with endocrine therapy (either an AI or tamoxifen), and who have not received prior systemic therapy for ABC. Gedatolisib is an intravenously administered pan-PI3K/mTOR inhibitor. Palbociclib is a CDK4/6 inhibitor. Fulvestrant is a selective estrogen receptor degrader (SERD). Following completion of the safety run-in phase to determine the gedatolisib dose with ribociclib, subjects will be assigned to 1 of 2 cohorts based on their PIK3CA status and then randomized to either the investigational treatment arm (gedatolisib with fulvestrant and ribociclib or palbociclib) or standard-of-care control arm (fulvestrant and ribociclib or palbociclib).

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Vanderbilt University Medical Center