Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)

Обзор

This is a post-marketing single arm, phase IV trial in which patients with high-risk early-stage HR+HER2- breast cancer will receive adjuvant abemaciclib in combination with endocrine therapy (ET) After study intervention, participants will remain on combination abemaciclib + ET at the discretion of their treating providers

Подробное описание

Dose escalation (DE) was shown to minimize the rates of Grade 3 diarrhea in the setting for HER2+ breast cancer. DE can improve tolerability for drugs such as abemaciclib. This is a post-marketing single arm, phase IV trial in which patients with high-risk early-stage HR+HER2- breast cancer will receive adjuvant abemaciclib in combination with endocrine therapy (ET) After study intervention, participants will remain on combination abemaciclib + ET at the discretion of their treating providers

In this study, the investigators we will test the hypothesis that gradual up-titration of abemaciclib dose over a course of 2-3 weeks will decrease the rate of G3 or worse diarrhea, permitting more patients to remain at the intended dose when evaluated at day 84

Вмешательства

• Препарат Abemaciclib
  Week 1 50mg orally BID
• Препарат Abemaciclib
  Week 2 100mg orally BID
• Препарат Abemaciclib
  Week 3+ 150mg orally BID

Первичные конечные точки

• Increase the proportion of subjects on FDA approved dose of Abemaciclib (150mg BID) at day 84 [Срок оценки: Day 84]

Вторичные конечные точки (8)

• How many days with Grade 2 or greater of diarrhea in the first month [Срок оценки: 1 month]
• Rate of Grade 3 or greater of diarrhea in the first 3 months [Срок оценки: 3 months]
• Disease Free Survival (DFS) [Срок оценки: 1 year]
• Disease Free Survival (DFS) [Срок оценки: 2 years]
• Overall Survival (OS) [Срок оценки: 1 year]
• Overall Survival (OS) [Срок оценки: 2 years]
• Overall Survival (OS) [Срок оценки: 3 years]
• Subject reported outcomes regarding adverse events [Срок оценки: 5 years]

Критерии участия

Критерии включения

• ECOG 0-2
• Histologically confirmed early-stage HR+HER2- breast cancer documented by biopsy who are prescribed adjuvant abemaciclib
• Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board (IRB) informed consent form and HIPAA authorization.
• Women of childbearing potential must not be pregnant or breast-feeding. A negative serum or urine pregnancy test is required per institutional practice guidelines.
• As determined at the discretion of the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.

Критерии исключения

• Chronic history of diarrhea
• Active infection requiring systemic therapy
• Uncontrolled HIV/AIDS or active viral hepatitis
• Pregnant or nursing
• Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating medical oncologist.
• Other major comorbidity as determined by study PI

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 3 центра

• University of Illinois — Chicago
• Iowa Holden Comprehensive Cancer Center — Iowa City
• Ohio State University Comprehensive Cancer Center — Columbus

Идентификаторы

NCT: NCT06169371 · 2023-0433

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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