{"entity":{"id":"nct06369285","kind":"trial","name":"A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer","aka":["ALISCA-Breast1"],"tldr":"A phase 2 trial of Alisertib in HR-positive / HER2-negative breast cancer, run by Puma Biotechnology, Inc., now recruiting.","summary":"A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer is a phase 2 interventional study registered as NCT06369285 by Puma Biotechnology, Inc., with 225 participants planned, started 2024-11-19 and due to reach its primary completion in 2027-12-30. Interventions recorded: Alisertib and Endocrine therapy.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06369285","url":"https://clinicaltrials.gov/study/NCT06369285"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["alisertib"],"companies":["puma-biotechnology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06369285","phase":"2","setting":"A Phase 2 Study of Alisertib in Combination With Endocrine Therapy in Patients With HR+, HER2-negative Recurrent or Metastatic Breast Cancer","sponsor":"Puma Biotechnology, Inc.","participation":[{"nct":"NCT06369285","source":"https://clinicaltrials.gov/study/NCT06369285","fetchedAt":"2026-10-07T16:54:36.402Z","studySha256":"169ce85a7c0f127ecdaf6a268b32e059223efee35b9734aeedb11525cc913308","overallStatus":"RECRUITING","lastUpdatePosted":"2026-10-01","leadSponsor":"Puma Biotechnology, Inc.","collaboratorCount":0,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":225,"enrolmentType":"ESTIMATED","siteCount":53,"recruitingSiteCount":52,"countries":["Portugal","Spain","United States"]}],"started":"2024-11-19","startedType":"actual","enrolled":225,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct06369285/","neighbours":{"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"}],"drug":[{"id":"alisertib","kind":"drug","name":"Alisertib","route":"/drugs/alisertib/"}],"company":[{"id":"puma-biotechnology","kind":"company","name":"Puma Biotechnology","route":"/companies/puma-biotechnology/"}],"institution":[{"id":"ucsf","kind":"institution","name":"UCSF Helen Diller Family Comprehensive Cancer Center","route":"/institutions/ucsf/"}]}}