- RecruitingPHASE1, PHASE2
Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer
This study is testing a new drug called elacestrant with other breast cancer medicines. It's for people with a specific type of advanced breast cancer that has spread. The main goals are to see if these drug combinations are safe and if they can help shrink the cancer.
For: Breast Cancer · Metastatic Breast CancerUnited States · Argentina · Australia - Ongoing, recruitingTherapeutic exploratory (Phase II)
BYLieve: A phase II, multicenter, open-label, three-cohort, non-comparative study to assess the efficacy and safety of alpelisib plus fulvestrant or letrozole in patients withPIK3CA mutant, hormone receptor (HR) positive, HER2-negative advanced breast cancer (aBC), who have progressed on or after prior treatments.
This study looks at new drug combinations for advanced breast cancer. It's for people whose cancer has a specific change (PIK3CA mutant) and has grown despite previous treatments. Researchers want to see if the new treatments can help people live longer without their cancer getting worse.
For: Adult patients with PIK3CA mutant · HR-positive · HER2-negative advanced breast cancerDenmark · Italy - Active not recruitingPHASE2
Study Assessing the Efficacy, Safety and PK of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum
This study is testing a new medicine, Alpelisib, for children and adults with a condition called PIK3CA-related overgrowth spectrum (PROS). Researchers want to see if it's safe and effective in helping manage the overgrowth caused by this condition.
For: PIK3CA-related Overgrowth Spectrum (PROS)United States · Canada · China - RecruitingPHASE2
EPIK-P4: A Phase II Single-arm Study to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum (PROS)
This study looks at how well a medicine called alpelisib works for children and adults with a condition called PROS, which causes parts of the body to grow too much. It also checks if the medicine is safe and how it moves through the body.
For: PIK3CA-related Overgrowth Spectrum (PROS)United States · Australia · Austria - Active not recruitingPHASE3
A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy
This study looks at two drug combinations, inavolisib with fulvestrant, and alpelisib with fulvestrant, for advanced breast cancer that has specific genetic changes and has already been treated with certain therapies. It aims to see which combination works better and is safer.
For: Breast CancerUnited States · Argentina · Australia - Active not recruitingPHASE3
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)
This study looks at new drug combinations for advanced breast cancer that has grown despite previous treatments. It compares different medications, including gedatolisib, fulvestrant, and palbociclib, to see if they are safe and effective.
For: Breast CancerUnited States · Argentina · Australia - Ongoing, recruitingTherapeutic exploratory (Phase II)
Study to evaluate the effect of metformin in the prevention of hyperglycemia in HR[+]/HER2[–] PIK3CA-mutated advanced breast cancer patients treated with alpelisib plus endocrine therapy. The Metallica study.
This study, called "Metallica," looks at how metformin might help prevent high blood sugar in people with a specific type of advanced breast cancer. These patients are taking a medicine called alpelisib along with other hormone therapies. The goal is to see if metformin reduces severe blood sugar issues.
Spain - Ongoing, recruitingTherapeutic exploratory (Phase II)
SAFIR 03_A ctDNA screening program in patients with HR+, HER2- metastatic breast cancer for detection of high-risk relapse patients on any CDK4/6 inhibitor and a randomised phase II study comparing alpelisib combined with fulvestrant to ribociclib combined with fulvestrant, in patients with persistent targetable PIK3CA mutations.
This study looks at new ways to treat advanced breast cancer that has spread. It's for women with a specific type of hormone-positive breast cancer. Researchers are comparing two different drug combinations to see which works best at stopping the cancer from growing.
For: Metastatic Breast Cancer HR+ · HER2-France - Ongoing, recruitingTherapeutic confirmatory (Phase III)
EPIK-O: A Phase III, multi-center, randomized (1:1), open-label, active-controlled study to assess the efficacy and safety of alpelisib (BYL719) in combination with olaparib as compared to single agent cytotoxic chemotherapy, in participants with no germline BRCA mutation detected, platinum-resistant or refractory, high-grade serous ovarian cancer
This study is looking at a new combination of two drugs, alpelisib and olaparib, for women with a specific type of advanced ovarian cancer that has come back or grown after previous treatment. It compares this combination to standard chemotherapy to see if it works better.
For: Platinum-resistant or refractory · high-grade serous ovarian cancer with no germline BRCA mutationGermany · Finland · Spain - Ongoing, recruitingTherapeutic confirmatory (Phase III)
EPIK-B2: A two part, Phase III, multicenter, randomized (1:1), double-blind, placebo-controlled study to assess the efficacy and safety of alpelisib (BYL719) in combination with trastuzumab and pertuzumab as maintenance therapy in patients with HER2-positive advanced breast cancer with a PIK3CA mutation
This study is looking at a new treatment called alpelisib, combined with two other drugs (trastuzumab and pertuzumab), for advanced HER2-positive breast cancer with a specific gene change (PIK3CA mutation). It aims to see how safe and effective this combination is.
For: HER2-positive advanced breast cancerFrance - Ongoing, recruitingTherapeutic confirmatory (Phase III)
A randomized phase III trial of trastuzumab + ALpelisib +/- fulvestrant versus trastuzumab + chemotherapy in patients with PIK3CA mutated previously treated HER2+ Advanced BrEasT cancer. “ALPHABET Study”
This study is for people with a specific type of advanced breast cancer that has already been treated. It will compare a new combination of drugs with a standard treatment to see if it works better. The aim is to find out if the new treatment can keep the cancer from growing for longer.
For: PIK3CA mutated HER2+ advanced or relapsed breast cancer (BC) previously treated with trastuzumabSpain