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Clinical Trials List

Protocol NumberI3Y-MC-JPCF
NCT Number(ClinicalTrials.gov Identfier)NCT03155997
Active

2017-09-01 - 2028-12-31

Phase III

Recruiting1

Terminated11

ICD-10C50

Malignant neoplasm of breast

ICD-10C79.81

Secondary malignant neoplasm of breast

ICD-9233.0

Carcinoma in situ of breast

A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone in Patients With High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer

  • Trial Applicant

    ELI LILLY AND COMPANY(TAIWAN), INC.

  • Sponsor

    Eli Lilly and Company

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator HWEI-CHUNG WANG Division of General Surgery
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 劉建廷 Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 戴明燊 Division of Hematology & Oncology
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 鍾奇峰 Division of Hematology & Oncology
Koo Foundation Sun Yat-Sen Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 張源清 Division of General Surgery
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Ling-Ming Tseng Division of General Surgery
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

11 Stop recruiting

Audit

None

Principal Investigator 陳守棟 Division of General Surgery
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator HWEI-CHUNG WANG 未分科
China Medical University Hospital-Taipei

Co-Principal Investigator

Audit

None

Principal Investigator TSU-YI CHAO Division of Hematology & Oncology
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

8 Stop recruiting

Audit

None

Principal Investigator Shin-Cheh Chen Division of General Surgery
Linkou Chang Gung Medical Foundation

Taiwan National PI

陳訓徹

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

16 Stop recruiting

Audit

None

Principal Investigator Ming-Feng Hou 未分科
Kaohsiung Municipal Gangshan Hospital

Co-Principal Investigator

Audit

None

Principal Investigator Chiun-Sheng Huang Division of General Surgery
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Audit

None

Principal Investigator Ming-Feng Hou Division of Gastroenterological Surgery
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer

Objectives

Primary To evaluate the efficacy, in terms of IDFS, for patients with HR+, HER2- early stage breast cancer for:  abemaciclib plus adjuvant endocrine therapy versus adjuvant endocrine therapy alone. Secondary To evaluate the efficacy, in terms of IDFS, for patients with HR+, HER2- early stage breast cancer with Ki67 index ≥20% (both Cohort 1 and Cohort 2 by central lab) To evaluate the efficacy of abemaciclib plus adjuvant endocrine therapy versus adjuvant endocrine therapy alone in terms of DRFS and OS To assess the safety profile of abemaciclib plus adjuvant endocrine therapy compared to adjuvant endocrine therapy alone To evaluate the relationship between abemaciclib, exposure and clinical (efficacy and safety) outcomes To evaluate abemaciclib plus adjuvant endocrine therapy, versus adjuvant endocrine therapy alone, in terms of general oncology and breast cancer selfreported health-related quality of life (FACT-B 37-item questionnaire), endocrine therapy-specific symptoms (the FACT-ES 19-item subscale and 2 FACIT-sourced items of cognitive symptoms and 3 FACIT-sourced items for bladder symptoms), and fatigue experienced during abemaciclib and/or endocrine therapy (the FACIT-F 13-item subscale). To evaluate health status to inform decision modeling for health economic evaluation using the EQ-5D-5L.

Test Drug

Abemaciclib

Active Ingredient

Abemaciclib (LY2835219)

Dosage Form

capsule

Dosage

50

Endpoints

Primary Outcome Measures :
Invasive Disease Free Survival (IDFS) [ Time Frame: Baseline to Recurrence or Death from Any Cause (Up to 32 Months) ]
IDFS, as defined by the STEEP System, was measured from the date of randomization to the date of first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, second primary non-breast invasive cancer, death attributable to any cause.


Secondary Outcome Measures :
IDFS for Participants With Ki-67 Index ≥20% [ Time Frame: Baseline to Recurrence or Death from Any Cause (Approximately 10 Years) ]
Outcome data will be provided after the study is completed.

Distant Relapse-Free Survival (DRFS) [ Time Frame: Baseline to Distant Recurrence or Death from Any Cause (Up to 32 Months) ]
Distant relapse-free survival is defined as the time from randomization to distant recurrence or death from any cause, whichever occurs first.

Overall Survival (OS) [ Time Frame: Baseline to Death from Any Cause (Approximately 10 Years) ]
Outcome data will be provided after the study is completed.

Pharmacokinetics (PK): Minimum Steady State Concentration (Cmin,ss) of Abemaciclib [ Time Frame: Day 1 (2 hours post-dose), Days 30, 60, 90 post-dose ]
Pharmacokinetics (PK): Minimum Steady State Concentration (Cmin,ss) of Abemaciclib

Change From Baseline on the Functional Assessment of Cancer Therapy - Breast (FACT-B) [ Time Frame: Baseline, Follow Up (Approximately 3 Years) ]
Outcome data will be provided after the study is completed.

Change From Baseline on the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) [ Time Frame: Baseline, Follow Up (Approximately 3 Years)] ]
Outcome data will be provided after the study is completed.

Change From Baseline on the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) [ Time Frame: Baseline, Follow Up (Approximately 3 Years)] ]
Outcome data will be provided after the study is completed.

Change From Baseline on the EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L) [ Time Frame: Baseline, Follow Up (Approximately 3 Years)] ]
Outcome data will be provided after the study is completed.

Inclution Criteria

Inclusion Criteria
A patient is eligible to be included in the study only if she/he meets all of the following criteria:
[1] Female or male ≥18 years of age (or of an acceptable age according to local
regulations, whichever is older).
[2] The patient has confirmed HR+, HER2-negative (HER2-), early stage resected
invasive breast cancer without evidence of distant metastases.
 To fulfill the requirement for HR+ disease by local testing on primary
disease specimen, tumor must be ER or PgR positive, defined as ≥1% of
tumor cells by immunohistochemistry (IHC) according to American
Society of Clinical Oncology (ASCO)/College of American Pathologists
(CAP) guidelines for hormone receptor testing (Hammond et al. 2010).
 To fulfill the requirement of HER2- disease by local testing on primary
disease specimen according to ASCO/CAP guidelines for HER2 testing
(Wolff et al. 2013), HER2- negative tumor is determined as:
- IHC score 0/1+; or
- IHC 2+ and in situ hybridization (ISH) non-amplified with a ratio of
HER2 to CEP17 <2.0, and if reported, average HER2 gene copy
number <4 signals/cells; or
- ISH non-amplified with a ratio of HER2 to CEP17 <2.0, and if
reported, average HER2 gene copy number <4 signals/cells.
[3] The patient must have undergone definitive surgical treatment for the current malignancy.
 For patients who undergo lumpectomy, the margins of the resected
specimen must be histologically free of invasive tumor and /or a component
of ductal carcinoma in situ (DCIS) as determined by the local pathologist.
If pathologic examination demonstrates tumor at the line of resection,
additional excisions may be performed to obtain clear margins. If tumor is
still present at the resected margin after re-excision(s), the patient must
undergo mastectomy to be eligible. Of note, patients with margins positive
for lobular carcinoma in situ (LCIS) are eligible without additional
resection.
 For patients who undergo mastectomy, the margins must be free of
residual gross tumor. Of note, patients with microscopic positive margins
are eligible as long as post-mastectomy radiotherapy of the chest wall is
administered prior to study entry.
 Radiation therapy (for example, post-mastectomy or post-lumpectomy)
should be administered according to standard guidelines.
[4] The patient must have tumor tissue for biomarker analysis available prior to
randomization. Preference is for tumor tissue collected prior to exposure to
systemic therapy (that is, adjuvant/neoadjuvant therapies).
Note: Sites should confirm the availability of tumor tissue (Section 9.8.2.2)
with the pathological laboratory prior to randomization.
[5] The patients must fulfill one of the following criteria based on timing of
definitive breast surgery:
A Patients who have received definitive breast surgery as their initial
treatment and are node positive (determined by either sentinel node
biopsy and/or axillary lymph node dissection) must have:
- pathological tumor involvement in ≥4 ipsilateral axillary lymph nodes
OR
- pathological tumor involvement in 1 to 3 ipsilateral axillary lymph
node(s) and meet at least 1 of the following criteria (prior to any
systemic therapy):
i. Ki67 index of ≥20% (for Cohort 2) as determined by the
investigational assay (described in Section 3.2.1) at a designated
central laboratory. Test should be performed on tumor tissue
collected at time of definitive breast surgery or from initial
diagnostic biopsy
ii. high histologic/nuclear Grade 3 as defined by the
Bloom-Richardson grading system (Elston and Ellis 2002).
Test should be performed on tumor tissue collected at time of
definitive breast surgery or from initial diagnostic biopsy
iii. pathological primary tumor size ≥5 cm
B Patients who have received neoadjuvant treatment (chemotherapy or
endocrine therapy) prior to definitive breast surgery must have:
- cytological (at time of initial diagnosis) or pathological (at time of definitive
breast surgery) tumor involvement in at least 1 ipsilateral axillary lymph node,
and meet at least 1 of the following criteria (prior to any systemic therapy):
i. Ki67 index of ≥20% (for Cohort 2) as determined by the
investigational assay (described in Section 3.2.1) at a designated
central laboratory. Test should be performed on tumor tissue from
initial diagnostic biopsy
ii. high histologic/nuclear Grade 3 as defined by the
Bloom-Richardson grading system (Elston and Ellis 2002). Test
should be performed on tumor tissue from initial diagnostic biopsy
iii. primary tumor size ≥5 cm on breast imaging (for example,
mammogram, ultrasound, or magnetic resonance imaging [MRI])
[6] The patient must be randomized within 12 weeks of completion of last
non-endocrine treatment (surgery, chemotherapy, or radiotherapy).
[7] If the patient is currently receiving or initiating standard adjuvant endocrine
therapy at time of study entry, she/he must not have received more than
8 weeks prior to randomization.
Neoadjuvant endocrine therapy does not count towards the maximum duration
of 8 weeks prior to randomization. Note: Adjuvant treatment with fulvestrant
is not allowed.
[8] Patients who received adjuvant chemotherapy must have recovered (Common
Terminology Criteria for Adverse Events [CTCAE] Grade ≤1) from the acute
effects of chemotherapy except for residual alopecia or Grade 2 peripheral
neuropathy prior to randomization. Patients who are not candidates for
adjuvant chemotherapy or decline chemotherapy are permitted. Patients may
also have received neoadjuvant chemotherapy. A washout period of at least
21 days is required between last adjuvant chemotherapy dose and
randomization (provided the patient did not receive radiotherapy).
[9] Patients who received adjuvant radiotherapy must have completed and fully
recovered from the acute effects of radiotherapy. A washout period of at least
14 days is required between end of radiotherapy and randomization.
[10] The patient has recovered from surgical side effects following definitive
breast surgery based on investigator discretion (for example, adequate wound
healing complications or seroma complications).
[11] Women regardless of menopausal status.
[12] Women of reproductive potential (also including women on ovarian
suppression with a GnRH agonist) must have a negative serum pregnancy test
at baseline (within 14 days prior to randomization) and agree to use highly
effective contraceptive methods to prevent pregnancy during the study and for
12 weeks following the last dose of study treatment. Males must agree to use
a reliable method of birth control and to not donate sperm during the study
and for at least 12 weeks following the last dose of study treatment. Refer to
Appendix 4 for definitions of highly effective method of contraception, and
definition for postmenopausal status has been defined in Appendix 5.
[13] The patient has a performance status ≤1 on the Eastern Cooperative Oncology
Group (Appendix 11) scale (Oken et al. 1982).
[14] The patient has adequate organ function for all of the following criteria, as
defined below.
[15] The patient is able to swallow oral medications.
[16] The patient has given written informed consent prior to any study-specific
procedures and is willing and able to make herself/himself available for the
duration of the study and amenable and able to follow study schedule during
treatment and follow-up.

Exclusion Criteria

Exclusion Criteria
A patient will be excluded from the study if she/he meets any of the following criteria:
[17] The patient has Stage IV (M1), Stage IA, and lymph node-negative breast
cancer (American Joint Committee on Cancer [AJCC] TNM Staging System
for breast cancer – 7th edition, Edge et al. 2009).
[18] The patient has a history of any other cancer (except non-melanoma skin
cancer or carcinoma in situ of the cervix), unless in complete remission with
no therapy for a minimum of 5 years. For patients with a history of other
cancers within 5 years and considered of very low risk of recurrence per
investigator’s judgment (for example, papillary thyroid cancer treated with
surgery), eligibility is to be discussed with Study Medical Monitor. Patients
with a history of previous breast cancer are excluded, with the exception of
LCIS or contralateral ductal carcinoma in situ treated by locoregional therapy
alone ≥5 years ago.
[19] Females who are pregnant or lactating.
[20] The patient has previously received treatment with any CDK4 and CDK6 inhibitor.
[21] The patient is receiving concurrent exogenous hormone therapy (for example,
birth control pills or hormone replacement therapy). Appropriate washout
period between last dose of exogenous hormone therapy and randomization is
up to the investigator’s medical judgment (for example, applying 5 times the
half-life elimination rule). Note: topical vaginal estrogen therapy is permitted
if all other non-hormonal options are exhausted.
[22] The patient has previously received endocrine therapy for breast cancer
prevention (tamoxifen or raloxifene or aromatase inhibitors).
[23] The patient has serious preexisting medical condition(s) that, in the judgment
of the investigator, would preclude participation in this study (for example,
interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy,
history of major surgical resection involving the stomach or small bowel, or
preexisting Crohn’s disease or ulcerative colitis or a preexisting chronic
condition resulting in baseline Grade 2 or higher diarrhea).
[24] The patient has a personal history of any of the following conditions: syncope
of cardiovascular etiology, ventricular arrhythmia of pathological origin
(including, but not limited to, ventricular tachycardia and ventricular
fibrillation), or sudden cardiac arrest. Exception: patients with controlled
atrial fibrillation for >30 days prior to randomization are eligible.
[25] The patient has active bacterial infection (requiring intravenous [IV]
antibiotics at time of initiating study treatment), fungal infection, or detectable
viral infection (such as known human immunodeficiency virus positivity or
with known active hepatitis B or C [for example, hepatitis B surface antigen
positive]. Screening is not required for enrollment.
[26] The patient has had surgery within 14 days prior to randomization.
[27] The patient has received an experimental treatment in a clinical trial within the
last 30 days or 5 half-lives, whichever is longer, prior to randomization (for
Japan, 4 months), or is currently enrolled in any other type of medical
research (for example: medical device) judged not to be scientifically or
medically compatible with this study.

The Estimated Number of Participants

  • Taiwan

    144 participants

  • Global

    4580 participants

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