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Medical Oncology","10700",{"type":67,"coordinates":1659},[1646,1647],{"lat":1647,"lon":1646},{"facility":1662,"status":74,"city":1663,"state":50,"zip":1664,"country":1642,"countryCode":1643,"cosmosGeoPoint":1665,"geoPoint":1669,"contacts":50},"Prince of Songkla University - Internal Medicine","Hat Yai","90110",{"type":67,"coordinates":1666},[1667,1668],100.47668,7.00836,{"lat":1668,"lon":1667},{"facility":1671,"status":74,"city":1672,"state":50,"zip":1673,"country":1642,"countryCode":1643,"cosmosGeoPoint":1674,"geoPoint":1678,"contacts":50},"Banphaeo General Hospital","Samut Sakhon","74120",{"type":67,"coordinates":1675},[1676,1677],100.27362,13.54753,{"lat":1677,"lon":1676},{"facility":1680,"status":74,"city":1681,"state":50,"zip":1682,"country":1683,"countryCode":50,"cosmosGeoPoint":1684,"geoPoint":1688,"contacts":50},"Adana Baskent Practice and Research Hospital - Oncology","Adana","1120","Turkey (Türkiye)",{"type":67,"coordinates":1685},[1686,1687],35.32531,36.98615,{"lat":1687,"lon":1686},{"facility":1690,"status":74,"city":1691,"state":50,"zip":1692,"country":1683,"countryCode":50,"cosmosGeoPoint":1693,"geoPoint":1697,"contacts":50},"Gulhane Training and Research Hospital - Medical Oncology","Ankara","06010",{"type":67,"coordinates":1694},[1695,1696],32.85427,39.91987,{"lat":1696,"lon":1695},{"facility":1699,"status":74,"city":1691,"state":50,"zip":1700,"country":1683,"countryCode":50,"cosmosGeoPoint":1701,"geoPoint":1703,"contacts":50},"Hacettepe University Medical Faculty - Hematology","06100",{"type":67,"coordinates":1702},[1695,1696],{"lat":1696,"lon":1695},{"facility":1705,"status":74,"city":1691,"state":50,"zip":1706,"country":1683,"countryCode":50,"cosmosGeoPoint":1707,"geoPoint":1709,"contacts":50},"Dr Abdurrahman Yurtaslan Training and Research Hospital - Medical Oncology","06200",{"type":67,"coordinates":1708},[1695,1696],{"lat":1696,"lon":1695},{"facility":1711,"status":74,"city":1691,"state":50,"zip":1712,"country":1683,"countryCode":50,"cosmosGeoPoint":1713,"geoPoint":1715,"contacts":50},"Memorial Ankara Hastanesi","06520",{"type":67,"coordinates":1714},[1695,1696],{"lat":1696,"lon":1695},{"facility":1717,"status":74,"city":1691,"state":50,"zip":1718,"country":1683,"countryCode":50,"cosmosGeoPoint":1719,"geoPoint":1721,"contacts":50},"Ankara University Medical Faculty - Oncology","06590",{"type":67,"coordinates":1720},[1695,1696],{"lat":1696,"lon":1695},{"facility":1723,"status":74,"city":1724,"state":50,"zip":1725,"country":1683,"countryCode":50,"cosmosGeoPoint":1726,"geoPoint":1730,"contacts":50},"Dicle University Medical Faculty Hospital Medical Oncology","Diyarbakır","21280",{"type":67,"coordinates":1727},[1728,1729],40.21721,37.91363,{"lat":1729,"lon":1728},{"facility":1732,"status":74,"city":1733,"state":50,"zip":1734,"country":1683,"countryCode":50,"cosmosGeoPoint":1735,"geoPoint":1739,"contacts":50},"Trakya University Medical Faculty - Oncology","Edirne","22030",{"type":67,"coordinates":1736},[1737,1738],26.55597,41.67719,{"lat":1738,"lon":1737},{"facility":1741,"status":74,"city":1742,"state":50,"zip":1743,"country":1683,"countryCode":50,"cosmosGeoPoint":1744,"geoPoint":1748,"contacts":50},"Medical Park Hastaneler Grubu - I.A.U. VM Medical Park Florya","Istanbul","34153",{"type":67,"coordinates":1745},[1746,1747],28.94966,41.01384,{"lat":1747,"lon":1746},{"facility":1750,"status":74,"city":1742,"state":50,"zip":1751,"country":1683,"countryCode":50,"cosmosGeoPoint":1752,"geoPoint":1754,"contacts":50},"Medipol Mega Hospital - Medical Oncology","34214",{"type":67,"coordinates":1753},[1746,1747],{"lat":1747,"lon":1746},{"facility":1756,"status":74,"city":1742,"state":50,"zip":1757,"country":1683,"countryCode":50,"cosmosGeoPoint":1758,"geoPoint":1760,"contacts":50},"Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital - Medical Oncology","34722",{"type":67,"coordinates":1759},[1746,1747],{"lat":1747,"lon":1746},{"facility":1762,"status":74,"city":1763,"state":50,"zip":1764,"country":1683,"countryCode":50,"cosmosGeoPoint":1765,"geoPoint":1769,"contacts":50},"Kocaeli Uni Egt ve Uyg Hast","İzmit","41001",{"type":67,"coordinates":1766},[1767,1768],29.92928,40.76499,{"lat":1768,"lon":1767},{"facility":1771,"status":74,"city":1772,"state":50,"zip":1773,"country":1683,"countryCode":50,"cosmosGeoPoint":1774,"geoPoint":1778,"contacts":50},"Necmettin Erbakan University Meram Medical Faculty - Oncology","Konya","42080",{"type":67,"coordinates":1775},[1776,1777],32.48464,37.87135,{"lat":1777,"lon":1776},{"facility":1780,"status":74,"city":1781,"state":50,"zip":1782,"country":1683,"countryCode":50,"cosmosGeoPoint":1783,"geoPoint":1787,"contacts":50},"VM Medical Park Mersin Hastanesi","Mezitli","33200",{"type":67,"coordinates":1784},[1785,1786],34.52256,36.74541,{"lat":1786,"lon":1785},{"type":1789,"investigatorFullName":50,"investigatorTitle":50,"investigatorAffiliation":50,"oldNameTitle":50,"oldOrganization":50},"SPONSOR","100574311","phase-3-phase-3-study-of-gedatolisib-as-first-line-treatment-for-patients-with-hr-positive-her2-negative-advanced-breast-cancer-viktoria-2-100574311",false,"NCT06757634","Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)","VIKTORIA-2: A Randomized, Open-Label, Phase 3 Study Evaluating Efficacy and Safety of Gedatolisib With Endocrine Therapy and Palbociclib vs Endocrine Therapy and Ribociclib as First-Line Treatment in Patients With HR-Positive and HER2-Negative Advanced Breast Cancer","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed diagnosis of metastatic or locally advanced HR+\u002FHER2- breast cancer\n2. Adult females, pre- and\u002For post-menopausal, and adult males. Pre-menopausal (and peri-menopausal) women can be enrolled if amenable to treatment with an LHRH agonist. Patients are to have commenced concomitant treatment with LHRH agonist prior to or on Cycle 1, Day 1 and must be willing to continue for the duration of the study.\n3. Negative pregnancy test for females of childbearing potential. Female subjects who are not surgically sterile must use a medically effective contraceptive method from screening until 2 years after the last dose of study treatment.\n4. Progression of disease during or within 12 months of completing (neo)adjuvant endocrine therapy (ET) or progression of disease after 12 months of completing (neo)adjuvant ET.\n5. Adequate archival, fresh tumor tissue, or liquid biopsy for the analysis of PIK3CA mutational status.\n6. Permitted prior therapies:\n\n   1. (neo)adjuvant fulvestrant only if the treatment duration \\\u003C 6 months\n   2. (neo)adjuvant chemotherapy\n   3. (neo)adjuvant CDK4\u002F6 inhibitor, unless PD was on or within 6 months of discontinuation of CDK4\u002F6i\n\n   i. Study 1: if disease progression was on or within event occurred \\>6 months of discontinuation after completion of CDK4\u002F6 inhibitor portion of treatment.\n\n   ii. Study 2: if disease progression event occurred \\>12 months after completion of CDK4\u002F6 inhibitor portion of treatment.\n7. Subject has radiologically measurable disease according to RECIST v1.1, per local assessment. Patients with nonmeasurable bone-only disease are not eligible. Patients with bone-only disease that has lytic or mixed lytic\u002Fblastic lesions and at least one measurable soft tissue component per RECIST v1.1 may be eligible.\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n9. Life expectancy of at least \\>6 months.\n10. Adequate bone marrow, hepatic, renal and coagulation function.\n\nExclusion Criteria:\n\n1. Concurrent malignancies other than adequately treated non-melanoma skin cancer. Previous malignancies in remission but curatively treated with no evidence of disease progression and judged by local Investigator to be at low risk of impacting health or survival while on study.\n2. Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor, a protein kinase B (Akt) inhibitor, or a mechanistic target of rapamycin (mTOR) inhibitor or any other selective estrogen receptor degrader (SERD), except fulvestrant, used in (neo)adjuvant setting.\n3. Prior treatment with systemic anticancer therapy for ABC\n4. Subjects with type 1 diabetes, or uncontrolled type 2 diabetes requiring daily insulin therapy.\n5. Known and untreated, or active, brain or leptomeningeal metastases\n6. History of clinically significant cardiovascular abnormalities\n7. Known, clinically significant ophthalmic conditions\n8. History of drug-induced symptomatic interstitial lung disease (pneumonitis) or hepatitis","ALL","18 Years",{"count":1800,"type":1801},1180,"ESTIMATED","INTERVENTIONAL",[1804],"PHASE3","This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib and palbociclib plus endocrine therapy for the treatment of patients with locally advanced or metastatic HR+\u002FHER2- advanced breast cancer.",[1807],"Breast Cancer",[1809,1810,1811,1812,1813,1814,1815],"Breast Cancer, Advanced or Metastatic","Gedatolisib","HR Positive","ER Positive","HER2 Negative","PIK3CA MT","PI3K","2026-05-14",{"date":1818,"type":1819},"2026-05-18","ACTUAL",{"date":1821,"type":1819},"2025-07-24",{"date":1823,"type":1801},"2033-07-30",{"name":5,"class":6},203]