On Thursday, Celcuity Inc. (NASDAQ:CELC) announced amendments to its Phase 3 VIKTORIA-2 clinical trial evaluating gedatolisib as a first-line treatment for patients with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer.
The company also disclosed progress on a subcutaneous formulation of gedatolisib aimed at supporting long-term treatment use.
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Trial To Include Endocrine-Sensitive Patients
Under the revised protocol, VIKTORIA-2 will now include a separate study evaluating patients with endocrine-sensitive HR+/HER2- advanced breast cancer in the first-line setting, in addition to the existing endocrine-resistant population.
