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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)

Comparing new treatments to standard care for advanced breast cancer.

Recruiting
18 years and older
All
Phase 3

This study is for people with advanced HR+/HER2- breast cancer, a type of cancer that grows because of hormones but doesn't have too much of a protein called HER2. The study is testing new treatments: gedatolisib, which stops some cancer growth signals, and fulvestrant, which blocks hormones that fuel cancer. Some participants will also get palbociclib, a drug that slows cancer cell growth. The study checks how well these treatments work and how safe they are.

  • Participation: You may be eligible if you have advanced breast cancer and have tried other treatments.
  • Duration and Visits: Regular visits are required for assessments and treatment over several months.
  • Risks and Benefits: Potential for side effects; discuss with your doctor if this trial is right for you.

Participants must not have certain health conditions like certain heart issues or uncontrolled diabetes. They also should not be pregnant or participating in other clinical trials. This study could help find better ways to treat this type of cancer. If you're interested, talk to your doctor to see if it's a good fit for you.

Study details
    Breast Cancer

NCT05501886

Celcuity Inc

31 March 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.

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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.
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