Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)
The VIKTORIA-2 study is a phase 3 clinical trial for people with advanced hormone-positive, HER2-negative breast cancer. Researchers are comparing different drug combinations to see which is safest and most effective as a first treatment. The new treatment involves a drug called gedatolisib, given with other established cancer medicines like palbociclib and either fulvestrant or letrozole. This is being compared to standard treatments such as ribociclib with fulvestrant or letrozole. The study aims to help patients whose cancer has either returned or spread, and it's particularly looking at whether patients have responded to hormone treatment before. This research could lead to improved treatment options for this type of breast cancer.
At a glance
What is this study about?
The VIKTORIA-2 study is a major research project for people with advanced breast cancer. This type of cancer is called \"hormone receptor-positive (HR+) and HER2-negative (HER2-)\", which means its growth is often linked to hormones, but it doesn't have high levels of a protein called HER2. In this study, doctors are looking for better ways to treat this cancer when it has spread in the body or can't be removed with surgery. They are comparing a new drug called gedatolisib, given alongside two other common medications – palbociclib and either fulvestrant or letrozole – against standard treatments that use similar drugs but replace gedatolisib with ribociclib.
This study is in \"Phase 3,\" which means it's a large trial testing treatments that have already shown promise in earlier research. The main goal is to see if the new combinations are more effective at stopping the cancer's growth and if they are safe to use. Patients will be grouped based on whether their cancer has responded well to hormone treatments in the past, or if it has become resistant. This helps researchers understand which treatment might work best for different people.
Knowing more about which drug combinations work best could offer new hope and better outcomes for people living with advanced HR+/HER2- breast cancer. The study is \"open-label,\" meaning both patients and their doctors will know which treatment they are receiving. By carefully comparing these treatments, the researchers hope to find new, effective ways to help patients manage their cancer and improve their quality of life.
Key takeaways
- The study explores new options for advanced hormone-positive, HER2-negative breast cancer.
- It compares a new drug combination with current standard treatments.
- Participants will know which treatment they are receiving.
- The study is a large, Phase 3 trial, aiming to find safer and more effective treatments.
- Eligibility depends on your cancer type, previous treatments, and overall health.
- You can stop participating at any time.
Who may be eligible?
To join this study, you would typically need to have breast cancer that has spread (metastatic) or is locally advanced, and it must be the HR+/HER2- type. You can be an adult female (including those before or after menopause) or an adult male. If you are a woman of childbearing age, you'll need to use effective birth control throughout the study.
Your cancer must have either progressed during hormone therapy or within 12 months of finishing it, or it might have come back or spread 12 months or more after finishing hormone therapy, or be newly diagnosed as metastatic without previous hormone treatment. Doctors will also need a sample of your tumour tissue to check for certain genetic changes. You generally need to be fairly well and active, with a good overall health status, and live for at least another 6 months.
There are also some requirements about any previous cancer treatments you've had. For example, if you've had a type of drug called a CDK4/6 inhibitor before, there are specific timelines around when your cancer progressed in relation to that treatment to be eligible. Your cancer also needs to be measurable on scans, not just in the bones, unless there are other measurable parts.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Do I have advanced or metastatic HR+/HER2- breast cancer?
- Am I an adult, male or female?
- Has my cancer progressed during or after hormone therapy, or is it a new metastatic diagnosis?
- Is my general health and activity level considered good (ECOG 0-2)?
- Can my cancer be measured on scans, and not just in the bones (unless also other measurable areas)?
- Am I okay with providing a sample of my tumour tissue for analysis?
What does participation involve?
If you join the study, you'll be assigned to one of four treatment groups by chance, like flipping a coin. You and your doctors will know which treatment you are receiving. The treatments involve a combination of drugs which are given either by injection into a vein (gedatolisib) or as tablets. You'll have regular hospital visits for check-ups, blood tests, and scans to see how you're responding to the treatment and to monitor for any side effects. The exact number of visits will vary but will be frequent at first, then less often. Treatment will continue as long as it's helping you and any side effects are manageable. There will also be follow-up appointments after you stop treatment to monitor your health. The total time you're involved could be several years.
Potential risks and benefits
Locations (203)
- City of Hope Medical CenterVerified postcodeDuarte, United States· Not yet recruiting
- Providence Medical FoundationVerified postcodeFullerton, United States· Recruiting
- UCLA Hematology Oncology Santa MonicaVerified postcodeLos Angeles, United States· Recruiting
- BRCR Medical Center, Inc- Internal MedicineVerified postcodePlantation, United States· Recruiting
- BRCR Medical Center, INCVerified postcodeTamarac, United States· Recruiting
- The University of Kansas Cancer CenterVerified postcodeWestwood, United States· Recruiting
- Mercy Health-Paducah Cancer CenterVerified postcodePaducah, United States· Recruiting
- American Oncology Partners, P.A.Verified postcodeBethesda, United States· Recruiting
- Massachusetts General Hospital Cancer CenterVerified postcodeBoston, United States· Not yet recruiting
- Henry Ford Health SystemVerified postcodeDetroit, United States· Recruiting
- Saint Luke's Cancer InstituteVerified postcodeKansas City, United States· Recruiting
- Washington University School of Medicine in Saint LouisVerified postcodeSt Louis, United States· Recruiting
Common questions
What type of breast cancer is this study for?
This study is for advanced breast cancer that is hormone receptor-positive (HR+) and HER2-negative (HER2-), meaning its growth is linked to hormones but not to the HER2 protein.
What does 'first-line treatment' mean?
First-line treatment means this study is testing drugs for people who are receiving treatment for their advanced breast cancer for the first time.
Will I know which treatment I'm getting?
Yes, this is an 'open-label' study, so both you and your doctors will know which specific treatment combination you are receiving.
What are Gedatolisib, Palbociclib, Ribociclib, Fulvestrant, and Letrozole?
These are all different types of cancer drugs that work in specific ways to target cancer cells or block hormone effects. Gedatolisib targets certain pathways in cells, while Palbociclib and Ribociclib are in a class called CDK4/6 inhibitors. Fulvestrant and Letrozole are hormone therapies.
What if my cancer has spread to my bones only?
If your cancer has only spread to your bones without other measurable areas, you might not be eligible. They are looking for cancer that can be measured on scans.
How to find out more
Nadene Zack, MS
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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