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

Recruiting now · Phase 3

Conditions studied: Breast Cancer

In brief

This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib and palbociclib plus endocrine therapy for the treatment of patients with locally advanced or metastatic HR+/HER2- advanced breast cancer.

Key facts

Study ID

NCT06757634

Run by

Celcuity Inc

People needed

1180

Starts

2025-07-24

Expected to finish

2033-07-30

Last updated by the study team

2026-05-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed diagnosis of metastatic or locally advanced HR+/HER2- 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 for the duration of the study.
• 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.
• Progression of disease during or within 12 months of completing (neo)adjuvant endocrine therapy (ET) or progression of disease after 12 months of completing (neo)adjuvant ET.
• Adequate archival, fresh tumor tissue, or liquid biopsy for the analysis of PIK3CA mutational status.
• Permitted prior therapies:
• (neo)adjuvant fulvestrant only if the treatment duration < 6 months
• (neo)adjuvant chemotherapy
• (neo)adjuvant CDK4/6 inhibitor, unless PD was on or within 6 months of discontinuation of CDK4/6i
• i. Study 1: if disease progression was on or within event occurred >6 months of discontinuation after completion of CDK4/6 inhibitor portion of treatment.
• ii. Study 2: if disease progression event occurred >12 months after completion of CDK4/6 inhibitor portion of treatment.
• Subject has radiologically measurable disease according to RECIST v1.1, per local assessment. Patients with nonmeasurable 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.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Life expectancy of at least >6 months.
• Adequate bone marrow, hepatic, renal and coagulation function.

You may not qualify if…

• 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.
• Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor, a protein kinase B (Akt) inhibitor, or a mechanistic target of rapamycin (mTOR) inhibitor or any other selective estrogen receptor degrader (SERD), except fulvestrant, used in (neo)adjuvant setting.
• Prior treatment with systemic anticancer therapy for ABC
• Subjects with type 1 diabetes, or uncontrolled type 2 diabetes requiring daily insulin therapy.
• Known and untreated, or active, brain or leptomeningeal metastases
• History of clinically significant cardiovascular abnormalities
• Known, clinically significant ophthalmic conditions
• History of drug-induced symptomatic interstitial lung disease (pneumonitis) or hepatitis

Where it is running

• Icon Cancer Centre Southport — Southport, Australia (enrolling)
• The Queen Elizabeth Hospital — Woodville, Australia (enrolling)
• GenesisCare - St Andrews — Adelaide, Australia (enrolling)
• Breast Cancer Research Centre — Nedlands, Australia (enrolling)
• Westmead Hospital — Westmead, Australia (enrolling)
• UCLA Hematology Oncology Santa Monica — Los Angeles, California, United States (enrolling)
• American Oncology Partners, P.A. — Bethesda, Maryland, United States (enrolling)
• Providence Medical Foundation — Fullerton, California, United States (enrolling)
• Henry Ford Health System — Detroit, Michigan, United States (enrolling)
• BRCR Medical Center, INC — Tamarac, Florida, United States (enrolling)
• Sydney Adventist Hospital — Wahroonga, Australia (enrolling)
• SCL Health - Cancer Centers of Montana — Billings, Montana, United States (enrolling)
• Mercy Health-Paducah Cancer Center — Paducah, Kentucky, United States (enrolling)
• Clinical Research Alliance, Inc. — Westbury, New York, United States (enrolling)
• Stefanie Spielman Comprehensive Breast Center at Olentangy River Road — Columbus, Ohio, United States (enrolling)
• Rittenhouse Hematology/Oncology — Philadelphia, Pennsylvania, United States (enrolling)
• BRCR Medical Center, Inc- Internal Medicine — Plantation, Florida, United States (enrolling)
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Mays Cancer Center — San Antonio, Texas, United States (enrolling)
• Bon Secours St. Francis Medical Oncology Center — Midlothian, Virginia, United States (enrolling)
• Fred Hutchinson Cancer Center — Seattle, Washington, United States (enrolling)
• Saint Luke's Cancer Institute — Kansas City, Missouri, United States (enrolling)
• Washington University School of Medicine in Saint Louis — St Louis, Missouri, United States (enrolling)
• The University of Kansas Cancer Center — Westwood, Kansas, United States (enrolling)
• Hospital Universiti Sains Malaysia — Kota Bharu, Malaysia (enrolling)

Full record on ClinicalTrials.gov

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