Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Eli Lilly and Company
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
diagnosis of HR+, HER2+ breast cancer (BC)
unresectable locally advanced recurrent BC or metastatic BC
adequate tumor tissue available prior to randomization
measurable and/or non-measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
previously received:
* at least 2 HER2-directed therapies for advanced disease
* participant must have received trastuzumab emtansine (T-DM1) in any disease setting
must have received a taxane in any disease setting
may have received any endocrine therapy (excluding fulvestrant)
have postmenopausal status due to surgical / natural menopause or chemical ovarian suppression
performance status (PS) of 0 to 1 on the Eastern Cooperative Oncology Group scale
left ventricular ejection fraction (LVEF) of 50% or higher at baseline
adequate organ function
negative serum pregnancy test at baseline (within 14 days prior to randomization) and agree to use medically approved precautions to prevent pregnancy during the study and for 12 weeks following the last dose of abemaciclib if menopause induced by gonadotropin-releasing hormone (GnRH) agonist or radiation
discontinued previous localized radiotherapy for palliative purposes or for lytic lesions at risk of fracture at least 2 weeks prior to randomization and recovered from the acute effects of therapy
discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, and endocrine therapy), except trastuzumab, for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy
are able to swallow capsules
You may not be if
have visceral crisis
known central nervous system (CNS) metastases that are untreated, symptomatic, or require steroids to control symptoms
had major surgery within 14 days prior to randomization
received prior treatment with any cyclin-dependent kinase (CDK) 4 and CDK 6 inhibitor
received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of randomization for a nonmyelosuppressive or myelosuppressive agent, respectively
have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study
history within the last 6 months of symptomatic congestive heart failure, myocardial infarction, or unstable angina
history within the last 12 months of any of the following conditions: syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest
history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years
active bacterial, fungal infection, or detectable viral infection
have received any recent (within 28 days prior to randomization) live virus vaccination
hypersensitivity to trastuzumab, murine proteins, fulvestrant, or to any of the excipients
Clareo Health | A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer
