A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors
This research study is investigating a new medication called LOXO-783. It's designed for people with breast cancer or other solid tumours that have a particular genetic change called a PIK3CA mutation. The main goals are to check if LOXO-783 is safe to use, to identify any side effects, and to see how effective it is in treating these cancers. Participants might be involved in the study for up to three years, and potentially longer if the treatment is helping. The study uses different standard treatments alongside LOXO-783, such as Fulvestrant or Paclitaxel. This study helps doctors learn more about promising new treatments for specific types of cancer.
At a glance
What is this study about?
This study is about a new medicine called LOXO-783. Doctors want to understand more about its safety, any side effects it might cause, and how well it works against certain types of cancer. This medicine is being tested for people who have breast cancer or other solid tumours (lumps or growths) that have a specific change in their genes, known as a PIK3CA mutation. Think of a gene mutation as a tiny change in the body's instruction manual. Doctors believe that targeting this specific change might help treat the cancer.
Taking part in this study could involve being monitored for up to three years, or even longer if the treatment is found to be beneficial for you. You might receive LOXO-783 alongside other well-known cancer treatments that are already in use, such as Fulvestrant, Paclitaxel, or medicines like Anastrozole, Exemestane, or Letrozole. This allows researchers to compare how LOXO-783 works with and without these other medications.
The information gathered from this study is really important. It helps doctors and researchers decide if LOXO-783 could become a new treatment option for people with these specific types of cancer. By carefully studying the effects of the medicine, they can ensure new treatments are as safe and effective as possible.
Key takeaways
- Tests a new medicine, LOXO-783, for breast cancer and other solid tumours.
- Specifically targets cancers with a PIK3CA gene mutation.
- Aims to check safety, side effects, and effectiveness.
- Participation could last up to 3 years or longer.
- May involve other standard cancer treatments alongside LOXO-783.
Who may be eligible?
To join this study, you generally need to have advanced breast cancer or another solid tumour that has a specific gene change called a PIK3CA mutation. You also need to have stopped previous cancer treatments and have recovered from any major side effects. Your blood tests should show that your organs are working well, and you should be generally well enough to take part.
There are also some more specific requirements. For breast cancer patients, you might need to be postmenopausal if you are female, or use hormone-blocking treatment if you are male. Depending on the specific part of the study, you might have had a certain number of previous cancer treatments. Some parts of the study are for people who have received a specific type of previous treatment called a CDK4/6 inhibitor, and one part even includes people with Type 2 diabetes. The study is open to both men and women, aged 18 and over.
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 breast cancer or another solid tumour?
- Has my cancer been tested for a PIK3CA gene mutation?
- Have I recovered from the major side effects of any past cancer treatments?
- Am I aged 18 or over?
What does participation involve?
If you join this study, it could last for up to three years, or possibly even longer if the treatment is helping you. You will receive the study medication, LOXO-783, which may be given alongside other standard cancer treatments. You'll have regular hospital visits for check-ups, blood tests, and scans to see how the treatment is working and to monitor for any side effects. You'll need to follow the study schedule carefully, which will be explained to you by the study team. They will also keep a close eye on your health throughout the study period.
Potential risks and benefits
Locations (50)
- Mayo Clinic of ScottsdaleVerified postcodeScottsdale, United States
- UCLA Medical CenterVerified postcodeLos Angeles, United States
- UCSF Medical Center at Mission BayVerified postcodeSan Francisco, United States
- Stanford University HospitalVerified postcodeStanford, United States
- Mayo ClinicVerified postcodeJacksonville, United States
- Winship Cancer Center Emory UniversityVerified postcodeAtlanta, United States
- Massachusetts General HospitalVerified postcodeBoston, United States
- Dana-Farber Cancer InstituteVerified postcodeBoston, United States
- Mayo ClinicVerified postcodeRochester, United States
- Washington University Medical SchoolVerified postcodeSt Louis, United States
- Memorial Sloan Kettering Cancer CenterVerified postcodeNew York, United States
- Wilmot Cancer InstituteVerified postcodeRochester, United States
Common questions
What is LOXO-783?
LOXO-783 is a new investigational medicine being tested to treat certain cancers with a specific gene change.
What is a PIK3CA gene change?
It's a particular alteration in your body's genetic instructions that doctors believe might contribute to cancer growth, and that LOXO-783 aims to target.
How long will I be in the study?
Participation could last up to three years, or potentially longer if the treatment is helping you.
Can I leave the study if I want to?
Yes, you can choose to leave the study at any time, for any reason, and it won't affect your regular medical care.
Will I still receive my usual cancer treatment?
You might receive LOXO-783 with other standard cancer treatments, depending on the specific part of the study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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