Clinical trials
PIK3CA Mutation clinical trials
Below are recruiting pik3ca mutation clinical trials, each written for real people, not researchers. We’re tracking 16 recruiting studies, each written for real people, not researchers, below.
Recruiting studies
- NCT06789913RecruitingPhase 2
Testing RLY-2608 for growth disorders linked to PIK3CA mutations
This trial tests a new medicine, RLY-2608, that targets the specific genetic change (PIK3CA mutation) causing overgrowth conditions. It aims to see if the drug can slow or stop the growth of affected tissues.
Phoenix, ArizonaAges 2 years+ - NCT07524322RecruitingPhase 1
RGT-490 for Advanced Cancers With PIK3CA Mutations
This study tests a new drug called RGT-490 in patients with advanced solid tumors (cancers that have spread or cannot be removed by surgery) that have a specific genetic change called a PIK3CA mutation. The drug is designed to block a protein involved in cancer cell growth.
Los Angeles, CaliforniaAges 18 years+ - NCT07407504RecruitingPhase 1
GenSci145 for advanced solid tumors with PIK3CA mutation
This trial tests a new oral drug, GenSci145, alone or with other drugs, for people whose advanced cancer has a PIK3CA gene change and has grown after standard treatments. It aims to see if this drug can help shrink tumors or slow their growth.
Beijing, Beijing MunicipalityAges 18–75 - NCT05983159RecruitingPhase 2
Targeted therapy for slow-flow or fast-flow vascular malformations
This trial tests two targeted medicines for people with certain types of vascular malformations (abnormal blood vessels). If you have a slow-flow malformation, you may receive alpelisib; if you have a fast-flow malformation, you may receive mirdametinib. Genetic testing is needed to see if your malformation has a specific change that these drugs target.
Parkville, VictoriaAges 2 years+ - NCT06982521RecruitingPhase 3
Comparing two drug combinations for advanced breast cancer
This trial tests two different combinations of medicines for people with a certain type of advanced breast cancer (HR-positive, HER2-negative) that has a specific gene change called PIK3CA. The goal is to see which combination is better at slowing down the cancer.
Gilbert, ArizonaAges 18 years+ - NCT07383506RecruitingPhase 1
Study of a targeted pill for PIK3CA-mutated advanced cancers
This trial tests a new pill (CGT6297) that targets cancer cells with a specific PIK3CA gene change. It may be an option for people with certain advanced solid tumors, including endometrial or breast cancer, after standard treatments have stopped working.
Scottsdale, ArizonaAges 18 years+ - NCT05948943RecruitingPhase 2/Phase 3
Alpelisib for lymphatic malformations with a PIK3CA change
This trial tests alpelisib (a targeted medicine) for people who have lymphatic malformations (LyM) that cause symptoms and have a PIK3CA mutation. It may help shrink or control these lesions when other procedures are delayed until after the first 24 weeks.
Oakland, CaliforniaAges birth–100 years - NCT07347600Recruiting
Studying inavolisib for a type of advanced breast cancer
This study tests a targeted therapy called inavolisib for people whose breast cancer has spread (advanced or metastatic), is hormone receptor-positive and HER2-negative, has a PIK3CA mutation, and has stopped responding to hormone therapy. It aims to see if inavolisib is safe and works well for them.
Xiamen, FujianAges 18 years+ - NCT06706570Recruiting
PIK3CA gene testing for breast cancer
This trial tests for a specific gene change (PIK3CA mutation) in your breast cancer cells. The results will help doctors decide if a targeted treatment is right for you. It's for people with hormone-receptor-positive, HER2-negative breast cancer that has spread and not yet been treated in that setting.
Milan, MIAges 18 years+ - NCT06790693RecruitingPhase 3
Inavolisib plus hormone therapy for advanced breast cancer
This trial tests a new targeted therapy, inavolisib, combined with standard hormone therapy and a CDK4/6 inhibitor for people with a specific genetic mutation (PIK3CA) in their hormone receptor-positive, HER2-negative advanced breast cancer that has not been treated before. It compares this combination to a placebo plus the same standard treatments.
Goodyear, ArizonaAges 18 years+ - NCT05216432RecruitingPhase 1
RLY-2608 for PIK3CA-mutant advanced solid tumors and breast cancer
This early study (Phase 1) tests RLY-2608, a targeted cancer drug for tumors with a PIK3CA mutation. It studies the drug alone and combined with hormone therapy (and sometimes CDK4/6 or CDK4 medicines) to see safety, dose, and whether it can shrink tumors.
Tucson, ArizonaAges 18 years+ - NCT05894239RecruitingPhase 3
Tested targeted drug for HER2-positive breast cancer with PIK3CA changes
This Phase 3 study tests inavolisib plus Phesgo versus placebo plus Phesgo in people whose breast cancer has both HER2-positive and PIK3CA-mutated tumor markers. The goal is to see if adding inavolisib improves how well the treatment controls the cancer and how safe it is.
Gilbert, ArizonaAges 18 years+ - NCT06805812Recruiting
Predicting outcomes of CDK4/6 inhibitors plus hormone therapy for advanced breast cancer
This study looks at how well a type of targeted therapy (called CDK4/6 inhibitors) combined with hormone therapy works as the first treatment for advanced breast cancer that is hormone receptor-positive and HER2-negative. Researchers want to find patterns that could help predict which patients benefit most.
AvianoAges 18 years+ - NCT07054190RecruitingPhase 2
Testing Inavolisib in early-stage breast cancer with PIK3CA mutation
This trial is testing a drug called Inavolisib (a type of targeted therapy) given before surgery for people with early-stage, hormone receptor-positive, HER2-negative breast cancer that has a specific genetic change (PIK3CA mutation). The goal is to see if adding Inavolisib to standard endocrine therapy can shrink the tumor more effectively.
Los Angeles, CaliforniaAges 18 years+ - NCT07207070RecruitingPhase 3
New drug combination for PIK3CA-mutated breast cancer
This trial tests a new combination of two drugs (JS105 plus dalpiciclib and fulvestrant) against a standard combination (dalpiciclib plus fulvestrant) for people whose breast cancer has a PIK3CA mutation. The goal is to see if adding JS105 helps control the cancer longer.
Beijing, Beijing MunicipalityAges 18–75 - NCT06943313Enrolling by invitation
Breast cancer PET/CT imaging with a new tracer
This trial tests a new imaging agent (68Ga-pAKTi) that may help doctors see breast cancer cells with a PET/CT scan. It is for people with a specific genetic change in their tumor, and who have not yet had surgery to remove the cancer.
ShanghaiAges 18 years+
Hear when a new PIK3CA Mutation trial opens
We’ll email you when one opens — at most once a week, no account needed, unsubscribe anytime.
PIK3CA Mutation trials by city
Studies with a site in or near these metro areas.
PIK3CA Mutation trials by state
Studies with a site anywhere in these states.
Common questions
- Are there clinical trials for pik3ca mutation?
- Yes. Clin2 currently lists 16 recruiting pik3ca mutation studies from the U.S. registry, each rewritten for real people, not researchers, so you can see what it’s testing and who it’s for.
- How do I know if I qualify for a pik3ca mutation trial?
- Each study lists its eligibility criteria — rules about age, diagnosis, and prior treatments. On every Clin2 trial page we explain these in words written for real people and offer a short, optional pre-screen for a fit read. The study team makes the final decision.
- Does it cost anything to join a pik3ca mutation trial?
- Using Clin2 is always free. Many trials cover the cost of the study treatment and related visits; some reimburse travel. The study team explains exactly what’s covered before you decide.
Related conditions
Clin2 helps you find and understand clinical trials and does not provide medical advice. Study data comes from ClinicalTrials.gov. Talk with your doctor about whether a specific trial is right for you.