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or 2+. If IHC is 2+, a negative in situ hybridization (Fluorescent in situ hybridization (FISH), Chromogenic in situ hybridization (CISH), or Silver-enhanced in situ hybridization (SISH)) test is required by local laboratory testing.\n* Participant has at least one measurable lesion as per RECIST v1.1 criteria as assessed by Investigator (a lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation).\n* Participant has recurrence or progression of disease during or after combined AI (i.e. letrozole, anastrozole, exemestane) and CDK4\u002F6 inhibitor therapy. The combined AI and CDK4\u002F6 inhibitor therapy does not need to be the latest treatment regimen (including adjuvant setting).\n* Participant has received ≤ 2 prior lines of systemic therapies overall in the metastatic setting, of which a maximum of 1 line of prior treatment with chemotherapy (except for neoadjuvant\u002F adjuvant chemotherapy) is permitted.\n* The presence of PIK3CA mutation(s) determined in tumor tissue prior to enrollment either by a Novartis designated laboratory or in tumor tissue or plasma ctDNA by a local laboratory using a Food and Drug Administration (FDA)-approved PIK3CA Companion Diagnostics (CDx) test for alpelisib or the CE-IVD QIAGEN Therascreen® PIK3CA RGQ PCR test.\n* If female, then the participant must be in postmenopausal status.\n\nKey Exclusion Criteria:\n\n* Participant with symptomatic visceral disease or any disease burden that makes the participant ineligible for endocrine therapy (ET) per the Investigator's best judgment.\n* Participant who relapsed with documented evidence of progression more than 12 months from completion of (neo)adjuvant endocrine\u002Fendocrine-based therapy with no treatment for metastatic disease.\n* Participant has received prior treatment with fulvestrant, any oral selective estrogen receptor degrader (SERD), any Phosphatidylinositol-3-Kinase (PI3K), mammalian Target of Rapamycin (mTOR) or Protein Kinase B (AKT) inhibitor.\n\nOther Inclusion and Exclusion Criteria do apply","ALL","18 Years","100 Years",{"count":634,"type":635},210,"ACTUAL","INTERVENTIONAL",[638],"PHASE3","The purpose of this study is to complement Study CBYL719C2301 (SOLAR-1) and obtain more comprehensive data on the efficacy and safety of alpelisib (BYL719) in combination with fulvestrant compared with placebo plus fulvestrant in men or postmenopausal women with HR-positive, HER2-negative advanced breast cancer with a PIK3CA mutation who progressed or relapsed on or after treatment with an AI plus a CDK4\u002F6 inhibitor.",[641],"Breast Cancer",[24,29,643,644,645,646,647,648,649,650],"Advanced breast cancer","Phase III","HR-positive","HER-2 negative","CDK4\u002F6 inhibitor","PIK3CA mutation","Progression free survival","aromatase inhibitor","ACTIVE_NOT_RECRUITING","2026-08-20",{"date":654,"type":635},"2026-08-21",{"date":656,"type":635},"2021-12-17",{"date":658,"type":659},"2027-02-26","ESTIMATED",{"name":38,"class":6},69]