Image

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)

Exploring new treatments for advanced HR+/HER2- breast cancer.

Recruiting
18 years and older
All
Phase 3

This study is testing new treatments for a type of breast cancer where hormones help the cancer grow. It's called "HR+/HER2- breast cancer." "HR+" means hormone receptor-positive, and "HER2-" means human epidermal growth factor receptor 2 negative. This trial compares a combination of medicines: gedatolisib and fulvestrant, sometimes with another medicine called palbociclib, against standard treatment options. Gedatolisib blocks signals that help cancer grow, and fulvestrant stops estrogen from attaching to cancer cells. Palbociclib stops cancer cells from dividing.

Key Points:

  • This study will need participants whose cancer has not responded to certain previous treatments.
  • Participants will be randomly assigned to different treatment groups based on their cancer gene type.
  • Participation involves regular check-ups and tests to monitor treatment effects and side effects.

People cannot join if they have certain health issues, like uncontrolled diabetes or specific heart problems. Women must not be pregnant or breastfeeding. If you join, you cannot participate in other drug trials at the same time. The goal is to find out if these new combinations work better than current treatments. It's important to consider the study's requirements and potential risks before joining.

Study details
    Breast Cancer

NCT05501886

Celcuity Inc

5 January 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

  Other languages supported:

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.