Phase 3 Study of Gedatolisib in HR-Positive, HER2-Negative Advanced Breast Cancer Patients
Research type
Research Study
Full title
A Phase 3, Open Label, Randomized, Two Part Study Comparing Gedatolisib in Combination with Palbociclib and Fulvestrant to Standard of Care Therapies in Patients with HR Positive, HER2 Negative Advanced Breast Cancer Previously Treated with a CDK4/6 Inhibitor in Combination with Non Steroidal Aromatase Inhibitor Therapy (VIKTORIA 1)
IRAS ID
1006613
Contact name
Mark Mannebach
Contact email
Sponsor organisation
Celcuity, Inc.
Clinicaltrials.gov Identifier
Research summary
This phase 3 trial aims to investigate the safety and effectiveness of a new drug called gedatolisib at treating advanced breast cancer when combined with standard cancer drugs compared to standard-of-care treatments usually given to people with this type of breast cancer. \nGedatolisib is a drug that interferes with a process inside cells whose overactivity can lead to tumours resistant to certain standard cancer treatments.\nThis trial comprises two studies (Study 1 and Study 2), to which participants will be allocated based upon results of tests on their PIK3CA gene.\nStudy 1 participants will be randomly (by chance, like the flip of a coin) assigned to receive treatment in one of the following 3 groups (or “Arms“): Arm A (gedatolisib, palbociclib, and fulvestrant), Arm B (gedatolisib and fulvestrant), or Arm C (fulvestrant). There will be a 33% chance that Study 1 participants will be placed in any given arm.\nStudy 2 participants will be randomly assigned to one of the following 3 treatment Arms: Arm D (gedatolisib, palbociclib, and fulvestrant), Arm E (alpelisib and fulvestrant) or Arm F (gedatolisib and fulvestrant). There will be a 43% chance that Study 2 participants will be placed in either Arms D or E and a 14% chance they will be placed in Arm F.\nThe trial is planned to run in 6 hospitals in the UK and a further 855 hospitals around the world and will comprise a screening period of up to 28 days, a treatment period lasting until disease progression, unacceptable toxicity, death or withdrawal of participant consent occurs and a post-treatment follow-up period involving safety tests and quarterly telephone health check-ups. \nStudy assessments will include physical examinations, blood and urine samples, questionnaires, electrocardiograms, echocardiograms/Multigated Acquisition scans and Computed Tomography or Magnetic Resonance Imaging scans and bone or Positron Emission Tomography scans to determine disease status.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
23/SC/0058
Date of REC Opinion
4 Sep 2023
REC opinion
Further Information Favourable Opinion