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Clinical Trials List

Protocol NumberJ2J-MC-JZLH
NCT Number(ClinicalTrials.gov Identfier)NCT05514054
Active

2023-01-31 - 2032-12-03

Phase III

Recruiting11

ICD-10D48.60

Neoplasm of uncertain behavior of unspecified breast

ICD-10D48.61

Neoplasm of uncertain behavior of right breast

ICD-10D48.62

Neoplasm of uncertain behavior of left breast

ICD-9238.3

Neoplasm of uncertain behavior of breast

EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients Who Have Previously Received 2 to 5 Years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer With an Increased Risk of Recurrence

  • Trial Applicant

    ELI LILLY AND COMPANY(TAIWAN), INC.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

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

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 張耀仁 Division of General Surgery
Taipei Tzu Chi Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shang-Wen Chen Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chih-Chiang Hung Division of General Surgery
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳守棟 Division of General Surgery
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 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 Recruiting

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

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

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

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wei-Pang Chung Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

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

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 張源清 Division of General Surgery
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Breast Neoplasms

Objectives

1. The safety of Imlunestrant and any side effects that subjects may experience while receiving its treatment. 2. Whether Imlunestrant helps trial participants with early-stage breast cancer. 3. Effect of Imlunestrant compared to standard of care endocrine therapy.

Test Drug

Imlunestrant (LY3484356)ExemestaneTamoxifenAnastrozoleLetrozole

Active Ingredient

LY3484356
Exemestane
Tamoxifen
Anastrozole
Letrozole

Dosage Form

Tablet
Tablet
Tablet
Tablet
Tablet

Dosage

200 mg
25
20
1
2.5

Endpoints

Main evaluation indicators
1. Invasive disease-free survival (IDFS), excluding second non-primary invasive breast cancer

Secondary evaluation metrics
1. Distal recurrence-free survival; DRFS
2. Overall survival period; OS
3. Pharmacokinetics; PK
4. EORTC QLQ C30 assesses changes in physical functioning, role functioning, and overall health-related quality of life from the baseline period
5. FACT GP5 assesses the proportion of time spent on treatment in trials with high overall AE burden

Inclution Criteria

Inclusion Criteria:

Have a diagnosis of ER+, HER2- early-stage, resected, invasive breast cancer without evidence of distant metastasis.
Participants must have received at least 24 months but not more than 60 months of any adjuvant ET, from time of adjuvant ET initiation.
Participants may have received (neo) adjuvant chemotherapy and/or targeted therapy with a CDK4/6- or PARP- inhibitor.
Must have an increased risk of disease recurrence based on clinical-pathological risk features.
Have a Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group scale.
Have adequate organ function.

Exclusion Criteria

Exclusion Criteria:

Have any evidence of metastatic disease (including contralateral ALN) or inflammatory breast cancer at primary breast cancer diagnosis.
Participants with more than a 6-month consecutive gap in therapy during the course of prior adjuvant ET.
Participants who have completed or discontinued prior adjuvant ET >6 months prior to screening.
Participants with a history of previous breast cancer are excluded, with the exception of ipsilateral DCIS treated by locoregional therapy alone ≥5 years ago.
Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 180 days after the last dose of study intervention.
Participant has previously received ET of any duration for breast cancer prevention (tamoxifen or AIs) or raloxifene.
Participants with a history of any other cancer.
Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study.

The Estimated Number of Participants

  • Taiwan

    219 participants

  • Global

    8000 participants

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