Clinical Trials List
2016-08-01 - 2020-12-31
Phase II
Terminated6
ICD-10C50
Malignant neoplasm of breast
ICD-10C79.81
Secondary malignant neoplasm of breast
ICD-9174.0
Malignant neoplasm of female breast, nipple and areola
A Randomized, Open-Label, Phase 2 Study of Abemaciclib plus Tamoxifen or Abemaciclib Alone, in Women with Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Breast Cancer
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Trial Applicant
ELI LILLY AND COMPANY(TAIWAN), INC.
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Sponsor
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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
- Ta-Chung Chao Division of Hematology & Oncology
- Yi-Fang Tsai Division of General Surgery
- Chun-Yu Liu Division of Radiation Therapy
- 林永慧 Division of Radiology
- 金光亮 Division of General Surgery
- 林燕淑 Division of General Surgery
- 邱仁輝 Division of General Surgery
The Actual Total Number of Participants Enrolled
1 Stop recruiting
Audit
None
Co-Principal Investigator
Audit
None
Taiwan National PI
Co-Principal Investigator
- Yung-Chang Lin Division of General Surgery
- 張潤忠 Division of General Surgery
- Wen-Chi Shen Division of General Surgery
- Chi-Chang Yu Division of General Surgery
- Mengting Peng Division of General Surgery
- 沈士哲 Division of General Surgery
The Actual Total Number of Participants Enrolled
12 Stop recruiting
Audit
None
Co-Principal Investigator
- Yao-Yu Hsieh Division of Hematology & Oncology
- Wei-Hong Cheng Division of Hematology & Oncology
- Wei-Hwa Lee Division of Others -
- Tsu-Yi Chao Division of Hematology & Oncology
- 蘇勇誠 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
4 Terminated
Audit
None
Co-Principal Investigator
- Yao-Chung Wu Division of General Surgery
- 林智一 Division of Others
- Liang-Chih Liu Division of General Surgery
- Chih-Jung Chen Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Abemaciclib 150 mg Q12H plus tamoxifen
Abemaciclib 150 mg Q12H
Abemaciclib 200 mg Q12H plus primary prophylactic loperamide
To evaluate the efficacy of abemaciclib, monotherapy and in combination with tamoxifen, in terms of ORR, DoR, and OS
To assess the safety profile of abemaciclib monotherapy and in combination with tamoxifen
To characterize the PK of abemaciclib and its metabolites; in addition to tamoxifen and its active metabolite endoxifen
To compare self-reported pain, pain interference, symptom burden, health status, and overall quality of life
Inclution Criteria
[1] Have confirmed HR+, HER2-negative (HER2-) recurrent, locally advanced, unresectable or metastatic breast cancer with evidence of relapse or disease progression following endocrine therapy.
• To fulfill the requirement for HR+ disease by local testing, a breast cancer must express, at least 1 of the hormone receptors (ER or progesterone receptor [PgR]). For ER and PgR assays to be considered positive, ≥1% of tumor cell nuclei must be immunoreactive by immunohistochemistry (IHC) (Hammond et al. 2010).
• To fulfill the requirement of HER2- disease by local testing on most recent biopsy, HER2- negative tumor is determined as immunohistochemistry score 0/1+ or negative by in situ hybridization (FISH/CISH/SISH), as defined in the relevant American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines (Wolff et al. 2013).
[2] Must have received prior treatment with at least 2 chemotherapy regimens:
- At least 1 of these regimens must have been administered in the metastatic setting.
- The additional chemotherapy regimens could have included, but are not limited to any of the following: capecitabine, eribulin, gemcitabine, an anthracycline, vinorelbine, or taxane.
No more than 2 prior chemotherapy regimens in the metastatic setting.
[3] Have the presence of measureable disease as defined by the Response Evaluation Criteria in Solid Tumors (for RECIST 1.1 refer to Appendix 8).
[4] Have adequate organ function for all of the following criteria, as defined below:
Please refer Table listed in Protocol Page 28
[5] Have a performance status ≤1 on the Eastern Cooperative Oncology Group (ECOG; Appendix 9) scale (Oken et al. 1982).
[6] Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy. Patients must have discontinued from previous treatments, as shown below:
Please refer Table listed in Protocol Page 28
[7] Are female and ≥18 years of age.
[8] Women of child-bearing potential must have a negative serum pregnancy test at baseline (within 7 days prior to randomization), and agree to use a medically approved non-hormonal contraceptive method during the treatment period and for 3 months following the last dose of the study drug. Effective methods of contraception include intrauterine device [IUD] or barrier methods. If condoms are used as a barrier method, a spermicidal agent should be added as a double barrier protection.
Refer to Appendix 1 for definitions of effective method of contraception.
[9] Have an estimated life expectancy of ≥12 weeks.
[10] Are willing to make themselves available for the duration of the study and are willing to follow study procedures.
[11] Have given written informed consent prior to any study-specific procedures.
Refer to Appendix 2 for study governance, regulatory, and ethical considerations.
[12] Are able to swallow oral medications.
Exclusion Criteria
[13] Have a personal history of any of the following conditions: syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest. Subjects with controlled atrial fibrillation for >30 days prior to study treatment are eligible.
[14] Have history or evidence of central nervous system (CNS) metastasis on the MRI of brain obtained at baseline.
[15] Have a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix or breast), unless in complete remission with no therapy for a minimum of 3 years.
[16] Are pregnant or lactating.
[17] Have active bacterial, fungal, and/or known viral infection (for example, human immunodeficiency virus [HIV] antibodies, hepatitis B surface antigen [HBSAg], or hepatitis C antibodies [HCAb]). Screening is not required for enrollment.
[18] Have received prior treatment with any CDK4 and CDK6 inhibitor.
[19] Known hypersensitivity to loperamide hydrochloride or to any of the excipients.
[20] Have a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea.
[21] Have visceral crisis. Visceral crisis is not the mere presence of visceral metastases but implies severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of the disease.
[22] Are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
[23] History or evidence of thromboembolic disease including any of the following, history of stroke, deep vein thrombosis (DVT), or pulmonary embolism (PE). Patients with documented hypercoagulable state are not eligible.
[24] Are receiving treatment with Warfarin or coumarins.
The Estimated Number of Participants
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Taiwan
15 participants
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Global
225 participants
