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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

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

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

Arm	Description	Assigned 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

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

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

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

More Details

NCT ID: NCT06757634
Status: Recruiting
Sponsor: Celcuity Inc

Study Contact

Nadene Zack, MS
844-310-3900
viktoria-2_eligibility@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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.