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neoMONARCH
2014-005486-75Phase 2
Key facts
- Status
- Completed
- Start
- Jun 2015
- Countries
- 1
- Sponsor
- Eli Lilly and Company
- Modality
- Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules, Irreversible Covalent Inhibitors → Covalent Small Molecules → Small Molecules, Small Molecules
- Conditions
- breast cancerhormone receptor-positive/HER2-negative breast cancer
01
Overview
Phase 2, randomised, open-label trial in breast cancer and hormone receptor-positive/HER2-negative breast cancer comparing Abemaciclib + anastrozole lead-in, Abemaciclib monotherapy lead-in and Anastrozole monotherapy lead-in (3 arms). Primary endpoint: Percent change in Ki67 expression from baseline to 2 weeks. Started Jun 2015; status: completed.
02
Design
3 arms- Study design
- RandomizedOpen-label
Abemaciclib + anastrozole lead-in
Patients received 2 weeks of abemaciclib with anastrozole followed by 14 more weeks of the same combination.
Abemaciclib monotherapy lead-in
Patients received 2 weeks of abemaciclib alone followed by 14 weeks of abemaciclib with anastrozole.
Anastrozole monotherapy lead-in
Patients received 2 weeks of anastrozole alone followed by 14 weeks of abemaciclib with anastrozole.
03
Who it enrols
Postmenopausal women aged 18 years or older with primary adenocarcinoma of the breast, tumor size at least 1 cm, hormone receptor-positive and HER2-negative disease, and disease suitable for neoadjuvant endocrine monotherapy and baseline core biopsy. Excludes bilateral invasive disease, metastatic or inflammatory breast cancer, and prior systemic, radiotherapy, or anti-estrogen treatment relevant to the current breast cancer.
04
Endpoints
Primary
Percent change in Ki67 expression from baseline to 2 weeks
Secondary
Pathologic complete response
Clinical objective response
Radiologic response
Adverse events
Quality of life
Pharmacokinetics of abemaciclib and anastrozole
Ki67
Biomarkers
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