Title: Phase 3, open-label, randomized study comparing gedatolisib combined with fulvestrant with or without palbociclib to standard-of-care therapies in patients with HR-positive, HER2-negative advanced breast cancer previously treated with a CDK4/6 inhibitor in combination w/ non-steroidal aromatase inhibitor therapy

Responsible Party: Celcuity, Inc.

Description: Researchers are conducting a phase 3 trial to compare gedatolisib plus fulvestrant, with or without palbociclib, to standard treatment for locally advanced or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer after progression on or after CDK4/6 and aromatase inhibitor therapy.

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In this open-label, randomized trial, patients will be assessed for PIK3CA mutations and then randomly assigned to treatment according to their status.

Patients without PIK3CA mutations will receive 1 of 3 therapies: gedatolisib plus palbociclib and fulvestrant, gedatolisib plus fulvestrant, or fulvestrant monotherapy. Patients with PIK3CA mutations will receive 1 of 3 therapies: gedatolisib plus palbociclib and fulvestrant, alpelisib plus fulvestrant, or gedatolisib plus fulvestrant.

The primary outcome is progression-free survival. Secondary outcomes include overall survival, overall response rate, duration of response, adverse events, and more.

To be eligible for this study, patients must be 18 years of age or older. They must have metastatic or locally advanced, HR-positive, HER2-negative breast cancer, adequate tumor tissue for analysis of PIK3CA mutational status, and a negative pregnancy test. For a complete list of eligibility criteria, please see the reference.

Status: Recruiting

This study is sponsored by Celcuity, Inc.


ClinicalTrials.gov. Gedatolisib plus fulvestrant with or without palbociclib vs standard-of-care for the treatment of patients with advanced or metastatic HR+/HER2- breast cancer (VIKTORIA-1). NCT05501886. Accessed September 1, 2023.