StudyFinder
A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer
Status: Recruiting
Disruption of estrogen signaling by drugs called selective estrogen receptor degraders (SERDs) is one of the treatment options for patients with estrogen receptor positive (ER+) cancers. Imlunestrant is a SERD that disrupts estrogen signaling, and therefore should stop or slow down tumor growth in ER+ cancers. This study will help answer research questions about the safety of imlunestrant and any side effects, and how imlunestrant compares to standard-of-care endocrine therapy.
Sex: Male or Female
Age Group: 18 years and over
Inclusion Criteria:
• diagnosis of ER+, HER2- early-stage invasive breast cancer without evidence of distant metastasis
• completed surgery
• received at least 24 months but not more than 60 months of any endocrine therapy after treatment
• may be limited with strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
Exclusion Criteria:
• any evidence of metastatic disease
• more than a 6 month consecutive gap in therapy during the course of prior adjuvant endocrine therapy
• history of any other cancer
• women who are pregnant, breastfeeding, or expecting to conceive or men expecting to father children
Interventions:
Drug: Anastrozole, Drug: Exemestane, Drug: Imlunestrant, Drug: Letrozole, Drug: Tamoxifen
Conditions:
Cancer
Keywords:
Breast cancer, ER+, Hormone positive, hormone therapy
Study Contact: Kris DeBoer - kdeboer1@fairview.org
Principal Investigator: Kiran Lassi
Phase: PHASE3
IRB Number: STUDY00018436
See this study on ClinicalTrials.gov