ABEMACICLIB for Breast cancer

Inclusion criteria

• {"criterion_text":"- Women (regardless of menopausal status) or men ≥18 years of age (or per local regulations)."}
• {"criterion_text":"- The participant has a Eastern Cooperative Oncology Group (ECOG) performance status ≤1."}
• {"criterion_text":"- The participant has adequate organ function."}
• {"criterion_text":"- The participant is able to swallow oral medications."}
• {"criterion_text":"- The participant has confirmed HR+, HER2-, early stage resected invasive breast cancer without evidence of distant metastases."}
• {"criterion_text":"- The participant must have undergone definitive surgery of the primary breast tumor."}
• {"criterion_text":"- The participant must have tumor tissue from breast (preferred) or lymph node for exploratory biomarker analysis available prior to randomization."}
• {"criterion_text":"- Pathologic lymph node involvement and at least one of the following indicating a higher risk of recurrence: 4 or more positive axillary lymph nodes, Tumor size of at least 5 centimeters, Grade 3 defined as at least 8 points on the Bloom Richardson grading system, Ki-67 index by central analysis of ≥20% on untreated breast tissue."}
• {"criterion_text":"- The participant must be randomized within 16 months from the time of definitive breast cancer surgery."}
• {"criterion_text":"- The participant may receive up to 12 weeks of endocrine therapy until randomization following the last non-endocrine therapy (surgery, chemotherapy, or radiation) whichever is last."}
• {"criterion_text":"- Participants must have recovered (grade ≤1) from the acute effects of chemotherapy and radiotherapy and from surgical side effects following definitive breast surgery."}
• {"criterion_text":"- Women of reproductive potential must have a negative blood pregnancy test and agree to use highly effective contraceptive methods."}

Exclusion criteria

• {"criterion_text":"- Metastatic disease (including contralateral axillary lymph nodes) or node-negative disease."}
• {"criterion_text":"- The participant has active systemic infections or viral load."}
• {"criterion_text":"- The participant has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer."}
• {"criterion_text":"- Participants with inflammatory breast cancer."}
• {"criterion_text":"- Participants with a history of previous breast cancer, with the exception of ipsilateral ductal carcinoma in situ (DCIS) treated by locoregional therapy alone ≥5 years ago. Participants with a history of contralateral DCIS treated by local regional therapy at any time may be eligible. Participants with 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 from the date of randomization are excluded."}
• {"criterion_text":"- Females who are pregnant or lactating."}
• {"criterion_text":"- The participant has previously received treatment with any CDK4 and CDK6 inhibitor."}
• {"criterion_text":"- The participant is receiving concurrent exogenous reproductive hormone therapy (for example, birth control pills, hormone replacement therapy, or megestrol acetate)."}
• {"criterion_text":"- The participant has previously received endocrine therapy for breast cancer prevention (tamoxifen or aromatase inhibitors) or raloxifene."}
• {"criterion_text":"- The participant has serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study."}
• {"criterion_text":"- The participant has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin or sudden cardiac arrest. Any participant with a history of venous thromboembolism (VTE)."}

Primary endpoints

• {"endpoint_text":"- Invasive Disease Free Survival (IDFS) [ Time Frame: Baseline to Recurrence or Death from Any Cause (Up to 32 Months)","definition_or_measurement_approach":"Time frame: Baseline to recurrence or death from any cause (up to 32 months)."}

Methods

• Third-party recruitment support: Publicis Healthcare Communications Group Ltd is listed with responsibility for patient screening, recruitment/retention. (No specific channels or country-specific recruitment channels described in the record.)

Portugal

Latest Decision Or Authorization Date

26-09-2025

Number Of Participants

37

Sweden

Latest Decision Or Authorization Date

29-04-2025

Number Of Participants

12

Poland

Latest Decision Or Authorization Date

29-04-2025

Number Of Participants

125

Germany

Latest Decision Or Authorization Date

10-11-2025

Number Of Participants

299

Denmark

Latest Decision Or Authorization Date

18-02-2026

Number Of Participants

112

Austria

Latest Decision Or Authorization Date

30-04-2025

Number Of Participants

36

Belgium

Latest Decision Or Authorization Date

25-04-2025

Number Of Participants

116

Romania

Latest Decision Or Authorization Date

30-04-2025

Number Of Participants

113

Greece

Latest Decision Or Authorization Date

29-04-2025

Number Of Participants

138

Italy

Latest Decision Or Authorization Date

29-04-2025

Number Of Participants

131

Finland

Latest Decision Or Authorization Date

29-04-2025

Number Of Participants

94

Czechia

Latest Decision Or Authorization Date

25-04-2025

Number Of Participants

27

Spain

Latest Decision Or Authorization Date

17-04-2026

Number Of Participants

292

France

Latest Decision Or Authorization Date

28-04-2025

Number Of Participants

187

Netherlands

Latest Decision Or Authorization Date

07-04-2026

Number Of Participants

19

Hungary

Latest Decision Or Authorization Date

29-07-2025

Number Of Participants

52

Primary sponsor

Full Name

Eli Lilly & Co.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Iqvia Rds Inc.

Responsibilities

Sponsor duties entries include code: 1 (patient support/operational role listed; specific responsibilities not detailed in record)

Name

Pharmaceutical Product Development LLC

Responsibilities

Sponsor duties entries include code: 10 (specific responsibilities not detailed in record)

Name

RWS Life Sciences Inc.

Responsibilities

Sponsor duties entries include code: 6 (specific responsibilities not detailed in record)

Name

Labcorp Central Laboratory Services S.a.r.l.

Responsibilities

Central laboratory services (sponsor duties code: 4)

Name

Pharmaserve Lilly S.A.C.I.

Responsibilities

Multiple sponsor duties including site agreements and payments: "Negotiation and Execution of Clinical trial agreements with the participating sites, make study payments based on invoices" (plus other coded duties)

Third parties

• {"country":"United Kingdom","full_name":"Publicis Healthcare Communications Group Ltd.","duties_or_roles":"Patient Screening, Recruitment/Retention","organisation_type":"Health care"}
• {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"code: 1","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"code: 6","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"code: 10","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services S.a.r.l.","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"Greece","full_name":"Pharmaserve Lilly S.A.C.I.","duties_or_roles":"codes: 1, 12, 15, 2, 5; includes: \"Negotiation and Execution of Clinical trial agreements with the participating sites, make study payments based on invoices\"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Brightech International LLC","duties_or_roles":"code: 10","organisation_type":"Health care"}