Clinical Trials List
2022-01-10 - 2028-12-01
Phase III
Recruiting6
ICD-10C50.011
Malignant neoplasm of nipple and areola, right female breast
ICD-10C50.012
Malignant neoplasm of nipple and areola, left female breast
ICD-10C50.019
Malignant neoplasm of nipple and areola, unspecified female breast
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9174.0
Malignant neoplasm of female breast, nipple and areola
postMONARCH: A Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy of Abemaciclib Plus Fulvestrant to Placebo Plus Fulvestrant in Participants With HR+, HER2-, Advanced or Metastatic Breast Cancer Following Progression on a CDK4 & 6 Inhibitor and Endocrine Therapy
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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
Co-Principal Investigator
- Chi-Cheng Huang 無
- 馮晉榮 無
- 賴亦貞 無
- Yi-Fang Tsai 無
- Chun-Yu Liu 無
- 邱仁輝 無
- Ta-Chung Chao 無
- 陳彥蓁 未分科
- 林燕淑 無
- Jiun-I Lai 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Fang-Ming Chen 無
- 高理鈞 無
- 高捷妮 無
- 甘蓉瑜 無
- Junping Shiau Shiau 無
- Chieh-Han Chuang 無
- 巫承哲 無
- 乳房外科
- Shen Liang Shih 無
- Chung-Liang Li 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 沈士哲 無
- Mengting Peng 無
- Wen-Chi Shen 無
- 周旭桓 無
- Yung-Chang Lin 無
- Chan-Keng Yang 無
- Chi-Chang Yu 無
- Wen-Ling Kuo 無
- 阮昱翔 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Inclution Criteria
Have a diagnosis of HR+, HER2- locally advanced or metastatic breast cancer
Have radiologic evidence of disease progression or recurrence either
On treatment with a CDK4/6 inhibitor with aromatase inhibitor (AI) as initial therapy for advanced disease, or
On/after treatment with a CDK4/6 inhibitor plus endocrine therapy (ET) administered as adjuvant therapy for early stage breast cancer
Must be deemed appropriate for treatment with ET
If female, have a postmenopausal status by natural or surgical means
Have Response Evaluable Criteria in Solid Tumors (RECIST) evaluable disease (measurable disease and/or nonmeasurable disease)
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale (Oken et al. 1982)
Have adequate renal, hematologic, and hepatic organ function
Must be able to swallow capsules/tablets
Exclusion Criteria
Have symptomatic or untreated central nervous system metastasis
Have received any systemic therapy between disease recurrence/progression and study screening
Have received more than 1 line of therapy for advanced or metastatic disease.
Have received prior chemotherapy for metastatic breast cancer (MBC)
Have received prior treatment with fulvestrant, any investigational estrogen receptor (ER)-directed therapy (including selective ER degraders [SERDs] and non-SERDs), any phosphatidylinositol 3-kinase (PI3K)-, mammalian target of rapamycin (mTOR)-, or protein kinase B (AKT)-inhibitor
The Estimated Number of Participants
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Taiwan
36 participants
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Global
350 participants
