RWF_I3Y-MC-JPBH

A Phase 1b Study of Abemaciclib in Combination with Therapies for Patients with Metastatic Breast Cancer

The main purpose of this study is to evaluate the safety of a study drug known as LY2835219 in combination with different therapies (letrozole, anastrozole, tamoxifen, exemestane, exemestane plus everolimus, trastuzumab, or LY3023414 plus fulvestrant) for breast cancer that has spread to other parts of the body.

Inclusion Criteria:
• Have a diagnosis of hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancer for Parts A to E, and G.
• For Part G: Have measureable disease as defined by RECIST 1.1.
• For all Parts except Part F: Participants must have either post-menopausal status or pre-menopausal status if continuing or beginning ovarian suppression with a luteinizing hormone-releasing hormone (LHRH) agonist such as goserelin.
• Have adequate organ function, including:
o Hematologic: Absolute neutrophil count (ANC) ≥1.5 x 10^9/liter (L), platelets ≥ 100 x 10^9/L, and hemoglobin ≥ 8 gram/deciliter (g/dL).
o Hepatic: Bilirubin ≤1.5 times upper limits of normal (ULN), alanine aminotransferase (ALT) ≤ 3.0 times ULN.
o Renal: Serum creatinine ≤ 1.5 times ULN.
• Have a performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.
• Have discontinued all previous therapies for breast cancer (including chemotherapy, radiotherapy, immunotherapy, and investigational therapy), except for ongoing corresponding combination therapy, for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug(s), 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. For Part F: concurrent treatment with trastuzumab emtansine (T-DM1) is not allowed.

Exclusion criteria:
• Have metastatic breast cancer with severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of the disease.
• Have brain metastasis without prior radiotherapy.
• Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study (for example, history of major surgical resection involving the stomach or small bowel).
• Have central nervous system (CNS) metastasis and either radiotherapy or development of neurological changes ≤14 days prior to receiving study treatment. Participants may be receiving a stable dose of corticosteroids. Screening of asymptomatic participants without history of CNS metastasis is not required.
• For Part G: Have a baseline electrocardiogram (obtained from Day -14 to Day -1) with any of the following abnormal findings: ventricular arrhythmia, evidence of acute myocardial ischemia, heart block (of any degree), or QTc prolongation (defined as QTcB ≥450 milliseconds).
Phase I
NCT02057133
Oncology
Breast
Alison Conlin, M.D.
Eli Lilly and Company
Nikki Moxon
  • Oncology and Hematology Care Eastside
  • Oncology and Hematology Care Newberg
  • Oncology and Hematology Care Southeast
  • Oncology and Hematology Care Westside