TRADE: Dose Escalation Tolerability of Abemaciclib in HR+ HER2- Early

Status Recruiting

Clinical Trial Summary

In this research study, investigators are testing if a dose-increasing strategy for abemaciclib will have less side effects and be better tolerated than the standard dosage of abemaciclib for participants with early-stage high-risk hormone receptor positive breast cancer. The names of the study drugs involved in this study are: - Abemaciclib (CDK4 and CDK6 inhibitor) - Tamoxifen (Selective estrogen receptor modulator) - Anastrozole/Letrozole (Non-steroidal aromatase inhibitors) - Exemestane (steroidal aromatase inhibitor) - LHRH (Gonadotropin-releasing hormone agonist, or Luteinizing hormone-releasing hormone agonist)

Clinical Trial Description

This research study is a prospective, single-arm, open label, phase 2 study designed to evaluate if a dose-increasing strategy for abemaciclib will have less side effects and be better tolerated than the standard dosage of abemaciclib for participants with early-stage high-risk hormone receptor positive breast cancer. This research study involves adjuvant abemaciclib plus endocrine (anti-hormone) therapy that works to target breast cancer. Adjuvant therapy is treatment given after surgery, chemotherapy, and/or radiation therapy. The U.S. Food and Drug Administration (FDA) has approved abemaciclib as a treatment option for early-stage high-risk hormone receptor breast cancer. The FDA has also approved hormonal therapies as treatment for hormone receptor positive breast cancer. The research study procedures include screening for eligibility, study treatment including laboratory evaluations and questionnaires, blood tests, tumor biopsies, and stool collections. Participation in this research study is expected to last for at least 2 years and up to 5 years. It is expected that about 90 people will take part in this research study. Eli Lilly and Company is supporting this study by providing funding for the study and supplying the study drug, abemaciclib. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06001762
Study type	Interventional
Source	Dana-Farber Cancer Institute
Contact	Erica Mayer, MD, MPH
Phone	(617) 632-3800
Email	EMAYER@PARTNERS.ORG
Status	Recruiting
Phase	Phase 2
Start date	October 5, 2023
Completion date	January 1, 2027

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

TRADE: Dose Escalation Tolerability of Abemaciclib in HR+ HER2- Early Stage Breast Cancer

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms