Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
The main purpose of this study is to evaluate the efficacy of the study drug abemaciclib in postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locoregionally recurrent or metastatic breast cancer.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Have a diagnosis of HR+, HER2- breast cancer. Although not required as a protocol procedure, metastatic disease should be considered for biopsy whenever possible to reassess hormone receptor (HR) and human epidermal growth factor receptor 2 (HER2) status if clinically indicated.
Meet either Inclusion Criterion (2a) or Inclusion Criterion (2b). Participants meeting Inclusion Criterion 2a will be enrolled in Cohort A and participants meeting Inclusion Criterion 2b will be enrolled in Cohort B.
(2a) Have locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease.
Relapsed with radiologic evidence of progression less than 1 year from completion of or while receiving adjuvant endocrine therapy (except for letrozole or anastrozole) and have received no prior endocrine therapy for locoregionally recurrent or metastatic disease.
(2b) Have locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease.
Have postmenopausal status defined as meeting at least 1 of the following:
Have 1 of the following, as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1:
Have a performance status (PS) of ≤1 on the Eastern Cooperative Oncology (ECOG) scale.
Have adequate organ function, including:
Hematologic: absolute neutrophil count (ANC) ≥1.5 × 109/Liter (L), platelets
≥100 × 109/L, and hemoglobin ≥8 g/deciliter (dL). Participants may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator; however, initial study drug treatment must not begin earlier than the day after the erythrocyte transfusion.
Hepatic: Total bilirubin ≤1.5 times the upper limit of normal (ULN) and alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
≤3.0 times ULN (or ALT and AST ≤5 times ULN if liver metastases are present).
Renal: serum creatinine ≤1.5 times ULN.
Have 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 (until the toxicity resolves to either baseline or at least Grade 1) except for residual alopecia or peripheral neuropathy.
Are able to swallow capsules.
Are reliable, willing to be available for the duration of the study, and willing to follow study procedures.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
463 participants in 4 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal