Clinical Trials List
2015-07-31 - 2018-07-31
Phase II
Terminated4
ICD-10C50
Malignant neoplasm of breast
ICD-9174.0
Malignant neoplasm of female breast, nipple and areola
neoMONARCH: A Phase 2 Neoadjuvant Trial Comparing the Biological Effects of 2 Weeks of Abemaciclib (LY2835219) in Combination with Anastrozole to those of Abemaciclib Monotherapy and Anastrozole Monotherapy and Evaluating the Clinical Activity and Safety of a Subsequent 14 Weeks of Therapy with Abemaciclib in Combination with Anastrozole in Postmenopausal Women with Hormone Receptor Positive, HER2 Negative Breast Cancer
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Trial Applicant
ELI LILLY AND COMPANY(TAIWAN), INC.
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Sponsor
Eli Lilly and Company
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Chih-Jung Chen Division of General Surgery
- Liang-Chih Liu Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 邱仁輝 Division of General Surgery
- Ta-Chung Chao Division of Hematology & Oncology
- Yi-Fang Tsai Division of General Surgery
- 金光亮 Division of General Surgery
- Chun-Yu Liu Division of Hematology & Oncology
- 林永慧 Division of Radiology
The Actual Total Number of Participants Enrolled
1 Terminated
Audit
None
Co-Principal Investigator
Audit
CRO
Co-Principal Investigator
- 林璟宏 Division of Hematology & Oncology
- Wei-Wu Chen Division of Hematology & Oncology
- 郭文宏 Division of General Surgery
- SUNG-HSIN KUO Division of Hematology & Oncology
- 羅喬 Division of General Surgery
- YEN-SHEN LU Division of Hematology & Oncology
- 楊雅雯 Division of General Surgery
- MING-YANG WANG Division of General Surgery
- 張端瑩 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Efficacy:
• percent change in Ki67 expression from baseline to the core biopsy 2 weeks after the start of treatment
• pCR defined as absence of invasive cancer in the breast and sampled regional lymph nodes
• clinical response of the breast tumor to therapy as assessed by caliper measurement
• radiologic response of the breast tumor as assessed by radiologic or ultrasound assessment
Safety:
• adverse events
Health Outcomes:
• EORTC QLQ-C30
Pharmacokinetics:
• PK of abemaciclib and its metabolites and anastrozole
Pharmacodynamics:
• Ki67
Biomarkers:
• Whole blood, plasma, and tissue samples will be tested for biomarkers relevant to abemaciclib and the disease state and to correlate these markers to clinical outcomes.
Inclution Criteria
• Have postmenopausal status.
• Adenocarcinoma of the breast.
• Breast tumor ≥1 centimeter (cm) in diameter, HR+, HER2-.
• Neoadjuvant endocrine monotherapy is deemed to be a suitable therapy.
• Primary breast cancer that is suitable for baseline core biopsy.
• Have adequate organ function.
Exclusion Criteria
• Bilateral invasive breast cancer.
• Metastatic breast cancer (local spread to axillary lymph nodes is permitted).
• Inflammatory breast cancer.
• Prior systemic therapy or radiotherapy for invasive or non-invasive breast cancer in the same breast as currently being treated.
• Prior radiotherapy to the ipsilateral chest wall for any malignancy.
• Prior anti-estrogen therapy.
The Estimated Number of Participants
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Taiwan
32 participants
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Global
250 participants
