Adjuvant Abemaciclib–Endocrine Therapy for Node-Positive Breast Cancer

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Solution Overview

Problem

Current adjuvant therapies for node-positive, early stage, hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) breast cancer result in approximately 30% of women experiencing distant relapse with metastases, highlighting the need for more optimal adjuvant treatment to enhance distant relapse-free survival.

Innovation Solution

Administering abemaciclib, a CDK inhibitor, in combination with endocrine therapies such as tamoxifen, letrozole, or anastrozole, for a sufficient duration to increase distant relapse-free survival in patients with HR+ breast cancer.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If current standard of care adjuvant therapy (chemotherapy and endocrine therapy) is used, then treatment is provided to patients with node-positive, early stage, HR+, HER2− breast cancer, but approximately 30% of women experience distant relapse with metastases

Engineering Contradiction:

Improvedistant relapse-free survivalVSAvoiddistant relapse and metastases

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent combines abemaciclib (a CDK4/6 inhibitor) with endocrine therapy to create a multi-modal treatment regimen. This combination targets multiple pathways involved in tumor growth and progression, thereby improving distant relapse-free survival compared to endocrine therapy alone. The synergistic effect of combining cell cycle inhibition with hormonal pathway blockade addresses the high relapse rate in node-positive early stage breast cancer patients.

Inventive Principle:

Principle #5Merging (Combining)

2Reliability

If adjuvant cytotoxic chemotherapy and endocrine therapy are administered, then treatment coverage is provided, but the duration of action is insufficient to prevent distant relapse in 30% of patients

Engineering Contradiction:

Improvedistant relapse-free survivalVSAvoidtreatment duration and efficacy persistence

Core Design Contradiction:

ReliabilityVSDuration of action of moving object

Solution Approach 1:

The patent employs continuous administration of abemaciclib in combination with endocrine therapy to maintain sustained inhibition of CDK4/6 and hormonal pathway activity throughout the adjuvant treatment period. This continuous therapeutic pressure prevents tumor cell proliferation and progression over time, extending the effective duration of action to cover the critical window when distant relapse risk is highest.

Inventive Principle:

Principle #20Continuity of useful action

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The combination of abemaciclib with endocrine therapies significantly enhances distant relapse-free survival by inhibiting tumor growth and reducing recurrence, demonstrating a robust safety profile and clinical activity.

Implementation Method 1

abemaciclib, a CDK inhibitor

Methodology Applied

Scientific EffectCDK inhibition:

Implementation Method 2

endocrine therapies such as tamoxifen, letrozole, or anastrozole

Methodology Applied

Scientific EffectHormone receptor blockade:

Data Source

PatentUS20250319084A1Endocrine therapy and abemaciclib combination for the adjuvant treatment of node-positive, early stage, hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer

Publication Date: 2025.10.16 ELI LILLY & CO

AI summary

The present invention discloses an adjuvant treatment of node-positive, carly stage, hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2—) breast cancer comprising administering an effective amount of an endocrine therapy in combination with an effective amount of abemaciclib or a pharmaceutically acceptable salt thereof.