Clinical trial · Interventional
Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abemaciclib | Drug | Abemaciclib | ALIAS |
| Standard Adjuvant Endocrine Therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 150 mg Abemaciclib + Endocrine Therapy
- description
- Participants received Abemaciclib orally at 150 milligrams (mg) twice daily with at least 6 hours between doses for up to 2 years or until evidence of disease recurrence or other discontinuation criteria were met, whichever occurs first. Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.
- interventionNames
- Drug: Abemaciclib
- Drug: Standard Adjuvant Endocrine Therapy
- type
- OTHER
- label
- Endocrine Therapy
- description
- Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.
- interventionNames
- Drug: Standard Adjuvant Endocrine Therapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women (regardless of menopausal status) or men ≥18 years of age (or per local regulations). * The participant has confirmed HR+, HER2-, early stage resected invasive breast cancer without evidence of distant metastases. * The participant must have undergone definitive surgery of the primary breast tumor. * The participant must have tumor tissue from breast (preferred) or lymph node for exploratory biomarker analysis available prior to randomization. * 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 * The participant must be randomized within 16 months from the time of definitive breast cancer surgery. * 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. * Participants must have recovered (grade ≤1) from the acute effects of chemotherapy and radiotherapy and from surgical side effects following definitive breast surgery. * Women of reproductive potential must have a negative blood pregnancy test and agree to use highly effective contraceptive methods. * The participant has a Eastern Cooperative Oncology Group (ECOG) performance status ≤1. * The participant has adequate organ function. * The participant is able to swallow oral medications. Exclusion Criteria: * Metastatic disease (including contralateral axillary lymph nodes) or node-negative disease. * Participants with inflammatory breast cancer. * 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. * Females who are pregnant or lactating. * The participant has previously received treatment with any CDK4 and CDK6 inhibitor. * The participant is receiving concurrent exogenous reproductive hormone therapy (for example, birth control pills, hormone replacement therapy, or megestrol acetate). * The participant has previously received endocrine therapy for breast cancer prevention (tamoxifen or aromatase inhibitors) or raloxifene. * The participant has serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study. * 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). * The participant has active systemic infections or viral load. * The participant has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer.
References
Publications (13)
- DERIVEDJohnston S, Martin M, O'Shaughnessy J, Hegg R, Tolaney SM, Guarneri V, Del Mastro L, Campone M, Sohn J, Boyle F, Cortes J, Rugo HS, Goetz MP, Hamilton EP, Huang CS, Senkus E, Cicin I, Testa L, Neven P, Huober J, Shao Z, Wei R, Munoz M, San Antonio B, Shahir A, Rastogi P, Harbeck N. Overall survival with abemaciclib in early breast cancer. Ann Oncol. 2026 Feb;37(2):155-165. doi: 10.1016/j.annonc.2025.10.005. Epub 2025 Oct 17. PMID 41110697
- DERIVEDZhang Q, Shen K, Song CG, Ouyang Q, Liu Z, Liu Q, Feng J, Chiu JWY, Tang J, Jiang Z, Tseng LM, Wang X, Yang L, Qian C, Shao Z. Abemaciclib combined with endocrine therapy as adjuvant treatment for hormone-receptor-positive, HER2-, high-risk early breast cancer: 5-year Chinese population analysis of the phase III randomized monarchE study. Ther Adv Med Oncol. 2024 Oct 23;16:17588359241286775. doi: 10.1177/17588359241286775. eCollection 2024. PMID 39463748
- DERIVEDJohnston SRD, Rugo HS, Tolaney SM, Munoz Fernandez M, Wei R, Martin M. Abemaciclib plus endocrine therapy for HR+, HER2-, node-positive, high-risk early breast cancer: a plain language summary of the monarchE study. Future Oncol. 2024;20(28):2037-2048. doi: 10.1080/14796694.2024.2362095. Epub 2024 Jul 18. PMID 39023253
- DERIVEDRastogi P, O'Shaughnessy J, Martin M, Boyle F, Cortes J, Rugo HS, Goetz MP, Hamilton EP, Huang CS, Senkus E, Tryakin A, Cicin I, Testa L, Neven P, Huober J, Shao Z, Wei R, Andre V, Munoz M, San Antonio B, Shahir A, Harbeck N, Johnston S. Adjuvant Abemaciclib Plus Endocrine Therapy for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative, High-Risk Early Breast Cancer: Results From a Preplanned monarchE Overall Survival Interim Analysis, Including 5-Year Efficacy Outcomes. J Clin Oncol. 2024 Mar 20;42(9):987-993. doi: 10.1200/JCO.23.01994. Epub 2024 Jan 9. PMID 38194616
- DERIVEDGanfornina Andrades A, Fenix Caballero S, Salguero Olid A, Alegre Del-Rey Emilio J. Abemaciclib as adjuvant treatment for high-risk early breast cancer. Farm Hosp. 2024 Mar-Apr;48(2):75-78. doi: 10.1016/j.farma.2023.08.006. Epub 2023 Sep 19. English, Spanish.