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.
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.
To help you understand what participating in a clinical trial is like, here are some resources that may be helpful:
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.
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.
The VIKTORIA-1 website contains links to other websites operated by third parties. Celcuity makes no representations as to the information contained in these third parties’ websites and expressly disclaims any and all responsibility for their content.