Date: 2017-06-03
Type of
information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Eli Lilly (USA - IN)
Product: abemaciclib (LY2835219)
Action
mechanism:
- cell cycle inhibitor/cyclin dependant kinase inhibitor. Abemaciclib (LY2835219) is a cell cycle inhibitor, designed to block the growth of cancer cells by specifically inhibiting CDK 4 and 6. Although abemaciclib inhibits both CDK 4 and CDK 6, the results from the cell-free enzymatic assays have shown that it was most active against Cyclin D 1 and CDK 4.
Disease: HR+, HER2+ advanced breast cancer
Therapeutic
area: Cancer - Oncology
Country: Argentina,Australia,Belgium, Brazil, Canada, France, Germany, Greece, Italy, Republic of Korea, Mexico, Spain, UK, USA
Trial
details:
- monarcHER is a global Phase 2 study evaluating abemaciclib plus trastuzumab (with or without fulvestrant) in women with HR+, HER2+ advanced breast cancer. (NCT02675231)
- The MONARCH clinical trial program also includes the following studies:
- MONARCH 1: a global Phase 2 study evaluating the efficacy and safety of abemaciclib monotherapy in patients with HR+, HER2- advanced breast cancer who had prior endocrine therapy and chemotherapy for metastatic disease.
- MONARCH 2: a global Phase 3 study evaluating the efficacy and safety of abemaciclib, in combination with fulvestrant, in patients with HR+, HER2- advanced breast cancer who progressed on endocrine therapy.
- MONARCH 3: a global Phase 3 study evaluating the efficacy and safety of abemaciclib, in combination with an aromatase inhibitor, as initial endocrine-based therapy for postmenopausal women with HR+, HER2- advanced breast cancer who have had no prior systemic treatment for advanced disease.
- MONARCH plus: a Phase 3 study evaluating the efficacy and safety of abemaciclib, in combination with endocrine therapies, to support registration in China.
- neoMONARCH: a Phase 2 study evaluating abemaciclib in the neoadjuvant setting, alone or in combination with the non-steroidal aromatase-inhibitor anastrozole, in postmenopausal women with previously untreated early stage HR+, HER2- breast cancer.
- monarchE: a global Phase 3 study evaluating the efficacy and safety of abemaciclib in the adjuvant setting in patients with high-risk, early breast cancer.
Latest
news:
- • On June 3, 2017, Eli Lilly announced that the newly initiated monarchE adjuvant study will assess abemaciclib in patients with high-risk, early breast cancer.
Is
general: Yes
