High-Dose Abemaciclib for Early-Stage Breast Cancer

Recruiting in Palo Alto (17 mi)

+12 other locations

Overseen byErica L. Mayer, MD MPH

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is testing if adjusting the dose of abemaciclib, along with hormone treatments, will cause fewer side effects and be easier for patients with early-stage high-risk hormone receptor positive breast cancer to handle. The treatment works by blocking proteins and hormones that help cancer grow. Abemaciclib has shown potential in improving survival outcomes and quality of life in patients with advanced hormone receptor-positive breast cancer.

Eligibility Criteria

This trial is for men and women over 18 with high-risk hormone receptor positive, HER2- early-stage breast cancer. They must have completed surgery within the last 16 months, may already be on endocrine therapy, and should not have had chemotherapy or radiotherapy recently. Participants need to use effective nonhormonal contraception and cannot be pregnant or nursing.

Inclusion Criteria

I can swallow and keep down pills.

I finished my radiotherapy at least 14 days ago and have recovered from its immediate effects.

I am using reliable birth control methods during and 3 months after the study.

+13 more

Exclusion Criteria

I have a history of fainting due to heart issues, irregular heartbeats, or sudden cardiac arrest.

Serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study

Receipt of an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, prior to enrollment, or is currently enrolled in any other type of medical research judged by the sponsor-investigator not to be scientifically or medically compatible with this study

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Participant Groups

The TRADE study is testing a new way of giving abemaciclib where doses increase over time. This approach aims to see if it's easier for patients to handle than the standard dose. The trial includes other drugs like Tamoxifen and aromatase inhibitors that are commonly used in breast cancer treatment.

1Treatment groups

Experimental Treatment

Group I: AbemaciclibExperimental Treatment6 Interventions

Study procedures will be conducted as follows: * Cycles 1 - 24 * Days 1 - 28 of 28-day cycle: Predetermined dose of Abemaciclib 2 x per day. * Endocrine therapy 1 x per day. * In clinic visits with blood tests, questionnaires, and assessments: * Day 1 of Cycles 1, 2, and 3 * Day 15 of Cycles 1 and 2 * Every three cycles after Cycle 3 Day 1. * End of treatment visit with blood tests, questionnaires, assessments, and stool sample collection.

Abemaciclib is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Verzenio for:

Hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
HR+, HER2- node-positive early breast cancer

🇪🇺 Approved in European Union as Verzenio for: