PIK3CA-activated mutation – European Clinical Trials Information Network https://clinicaltrials.eu Bridging Patients with Clinical Trials Fri, 12 Jun 2026 11:16:08 +0000 en-US hourly 1 https://wordpress.org/?v=7.0 https://clinicaltrials.eu/wp-content/uploads/2024/12/cropped-EU_icon-32x32.png PIK3CA-activated mutation – European Clinical Trials Information Network https://clinicaltrials.eu 32 32 Study on Alpelisib and Fulvestrant for Advanced Breast Cancer in Patients with PIK3CA Mutation and Hormone-Receptor Positive, HER2 Negative Tumors https://clinicaltrials.eu/trial/study-on-alpelisib-and-fulvestrant-for-advanced-breast-cancer-in-patients-with-pik3ca-mutation-and-hormone-receptor-positive-her2-negative-tumors/ Mon, 04 May 2026 07:58:28 +0000 https://clinicaltrials.eu/trial/study-on-alpelisib-and-fulvestrant-for-advanced-breast-cancer-in-patients-with-pik3ca-mutation-and-hormone-receptor-positive-her2-negative-tumors/ This clinical trial is focused on studying advanced breast cancer that is hormone-receptor positive and HER2 negative, with a specific mutation known as PIK3CA. The study involves a combination treatment using two medications: fulvestrant and alpelisib (also known by its code name, BYL719). The purpose of the study is to explore the effectiveness of this combination treatment in patients whose cancer has progressed after previous therapy with fulvestrant.

Participants in the study will receive the treatment orally in the form of film-coated tablets. The study will last for a period of up to 52 weeks. During this time, the effects of the treatment will be monitored to assess how well it works in controlling the cancer and to evaluate any side effects. The study will also look into how the treatment impacts the quality of life of the participants and will gather information on how the body processes the medication.

The trial aims to provide valuable insights into the potential benefits of combining fulvestrant and alpelisib for treating this specific type of breast cancer. It will also help in understanding the management of side effects, such as alpelisib-induced hyperglycemia, which is an increase in blood sugar levels. The study will contribute to the knowledge of how these medications can be used effectively in patients with the PIK3CA mutation.

]]> Study of RLY-2608 for Adults and Children with PIK3CA-Related Overgrowth and Malformations https://clinicaltrials.eu/trial/study-of-rly-2608-for-adults-and-children-with-pik3ca-related-overgrowth-and-malformations/ Wed, 29 Apr 2026 15:04:57 +0000 https://clinicaltrials.eu/trial/study-of-rly-2608-for-adults-and-children-with-pik3ca-related-overgrowth-and-malformations/ This clinical trial is focused on studying a condition known as PIK3CA Related Overgrowth Spectrum and malformations caused by a mutation in the PIK3CA gene. The trial will explore the effects of a new treatment called RLY-2608, which is taken as a capsule. This treatment is designed to target and inhibit a specific protein that is affected by the PIK3CA mutation, potentially helping to manage the symptoms associated with this condition.

The purpose of the study is to determine the best dose of RLY-2608 for different groups of participants and to assess its safety and effectiveness. The study will be conducted in several parts. Initially, participants will receive RLY-2608 to find the most suitable dose and to monitor any side effects. In a later part of the study, the effectiveness of RLY-2608 will be compared to a placebo to see how well it works in reducing the size of the overgrowths or malformations.

Participants in the study will be monitored over a period of time to observe any changes in their condition and to ensure their safety. The study aims to provide valuable information on how RLY-2608 can be used to treat individuals with conditions driven by the PIK3CA mutation, potentially leading to improved treatment options in the future.

]]>