A Clinical trial
for patients
with breast cancer

Thank you for your interest in participating in this clinical trial. Patients from all around the world contribute to advances in breast cancer research by giving one of their most precious resources: time.

What is Viktoria-1?

VIKTORIA-1 is a clinical trial for patients with HR+/HER2-, Stage 3 or 4 breast cancer who have already been treated with certain cancer drugs, including Ibrance ®, Kisqali ®, or Verzenio ®. The goal of this clinical trial is to evaluate a new investigational drug called gedatolisib by comparing it to currently available drug options for patients. In this trial, one group of participants will receive gedatolisib combined with Ibrance and fulvestrant, another group of participants will receive gedatolisib combined only with fulvestrant, and another group will receive available therapies according to certain biological features of their tumor. That’s where you come in.

Participating in Clinical Trials

Before medications are approved for use, clinical trials must show that they are safe and that patients can benefit from them. To accomplish this, clinical trials enroll volunteer patients who may then get access to investigational study drugs before they’re available to the general population.

When you enroll in a clinical trial, you become part of a team of medical experts, researchers, and site staff. Your participation contributes to advances in treatment for future patients. Without patients like you, new drugs that may extend lives could not get approved. Prior to enrolling in a clinical trial, site staff will explain the potential risks and benefits of participating in the study to you.

Clinical trials may test new therapies that are prescribed alone and in combination with other drugs. In certain cases, treating patients with a combination of drugs may increase the effectiveness of each therapy.


Clinical trials take place at hospitals, clinics, and private doctor’s offices. These are often referred to as study sites. For some participants, the study site is their own doctor’s office. For other participants, they may need to receive study treatment at a new hospital or clinic, where they would meet a study doctor and team while continuing to work with their current health team.


Clinical trials are always voluntary. You can stop treatment at any time for any reason. In some cases, you may need to stop treatment due to your health condition. That is a decision typically made together with your study doctor and the study site staff.


Gedatolisib is an investigational drug, given intravenously (IV), that works differently than current treatments for patients with HR+/HER2- breast cancer. It blocks the activity of a pathway inside the cell known as PI3K/mTOR. This cellular pathway helps regulate the growth and function of cells in the body. In many different tumors, this pathway becomes very active, which can lead to rapid increases in the number of cancer cells. The VIKTORIA-1 clinical trial will help determine whether blocking the activity of the PI3K/mTOR pathway when gedatolisib is combined with other therapies can cause breast cancer tumors to stop growing or shrink.



Breast cancer not only has a significant impact on the patient but also their support community. Here are some resources for caregivers who might have questions about this diagnosis.

© 2022 Celcuity, Inc. All Rights Reserved.

Ibrance is a registered trademark of Pfizer, Inc. Kisqali is a registered trademark of Novartis AG. Verzenio is a registered trademark of Eli Lilly and Company.


The VIKTORIA-1 website is intended for informational purposes only.

While Celcuity has made every attempt to ensure that the information contained in this website is complete and accurate, Celcuity gives no express or implied representation in respect of the content of this website and is not responsible for any omissions, errors or delays in the update of any information contained herein. In no event shall PSI be liable for any indirect or consequential loss or damage arising out of or in connection with the use of this information.

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