TRADE: Testing Different Doses of Abemaciclib for Early Stage Hormone Receptor Positive Breast Cancer

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06001762

Provider View

This study is exploring if gradually increasing the dose of abemaciclib can reduce side effects and be better tolerated than the usual dose for patients with early-stage high-risk hormone receptor positive breast cancer.

Patient Parameters

Program Overview

This research is testing if increasing the dose of abemaciclib over time can be easier on patients and cause fewer side effects compared to the standard dose. The study involves using abemaciclib along with hormone therapies like tamoxifen, anastrozole, letrozole, exemestane, and LHRH. These treatments are given after surgery, chemotherapy, or radiation to help target breast cancer. The study will last between 2 to 5 years and involves about 90 participants. Eli Lilly and Company is providing support and the study drug.

Description

This study is designed to see if increasing the dose of abemaciclib gradually can be better tolerated by patients with early-stage high-risk hormone receptor positive breast cancer. The study involves taking abemaciclib along with hormone therapies that target breast cancer after surgery or other treatments. The U.S. FDA has approved abemaciclib and these hormone therapies for treating this type of breast cancer.

Participants will go through a screening process to check if they are eligible. The study includes taking the study drugs, regular lab tests, questionnaires, blood tests, tumor biopsies, and stool collections. The study will last for at least 2 years and up to 5 years, with about 90 people taking part. Eli Lilly and Company is supporting the study by providing funding and the study drug.

Eligibility Criteria

Inclusion Criteria

  • Have stage II or III node-positive hormone receptor positive (HR+) and HER2-negative (HER2-) breast cancer.
  • Be suitable for adjuvant abemaciclib treatment as determined by your doctor.
  • Be eligible for hormone therapy, which may have started before or at the time of joining the study.
  • Have had surgery to remove the primary breast tumor within 16 months before joining the study.
  • Have waited at least 21 days after the last chemotherapy dose and recovered from its side effects before starting the study.
  • Have waited at least 14 days after finishing radiotherapy and recovered from its side effects before starting the study.
  • Have waited at least 14 days after the most recent breast surgery and recovered from its side effects before starting the study.
  • Have good overall health with an ECOG performance status of 0 or 1.
  • Be 18 years or older, regardless of menopausal status.
  • Have adequate organ function as shown by specific blood tests.
  • Premenopausal women must have a negative pregnancy test.
  • Agree to use effective non-hormonal birth control during the study and for 3 months after the last dose of abemaciclib.
  • Be able to swallow pills.
  • Understand and agree to sign a consent form.

Exclusion Criteria

  • Have had previous treatment with any CDK4/6 inhibitor.
  • Have node-negative breast cancer.
  • Be receiving other investigational treatments.
  • Have inflammatory breast cancer.
  • Have a history of allergic reactions to abemaciclib or similar drugs.
  • Have a history of other cancers unless disease-free for at least five years, except for certain non-threatening cancers.
  • Have serious medical conditions that could interfere with the study.
  • Have a history of certain heart conditions.
  • Be pregnant, breastfeeding, or unwilling to use effective contraception.
  • Have received experimental treatment in another clinical trial recently.
  • Have active infections requiring IV antibiotics.
  • Have HIV with a CD4 count below 350 cells/uL or not on stable ART.
  • Have active or chronic Hepatitis B or C unless meeting liver function criteria.
  • Be taking medications that strongly interact with CYP3A4 unless stopped before the study.

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