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

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.

Trial Details

NCT ID

NCT06757634

Phase

PHASE3

Sponsor

Celcuity Inc

Status

RECRUITING

Cancer Type

HER2 Positive Breast Cancer

Interventions

Arm A: Gedatolisib + Palbociclib or Ribociclib + Fulvestrant
Arm B: Palbociclib or Ribociclib + Fulvestrant

Locations (sample)

Duarte, California, United States|34.13945,-117.97729
Fullerton, California, United States|33.87029,-117.92534
Los Angeles, California, United States|34.05223,-118.24368
Plantation, Florida, United States|26.13421,-80.23184
Tamarac, Florida, United States|26.21286,-80.24977

Key Eligibility Criteria

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 wi…
Negative pregnancy test for females of childbearing potential. Female subjects who are not surgically sterile must use a medically effective contra…
Progression of disease during or within 12 months of completing (neo)adjuvant ET.

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find HER2 Positive Breast Cancer Trials on Trialify →