NCT06001762

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

The TRADE Study: A Phase 2 Trial to Assess the ToleRability of Abemaciclib Dose Escalation in Patients With Early-Stage HR-positive and HER2-negative Breast Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed 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.

Conditions

• Breast Cancer
• Early-stage Breast Cancer
• High Risk Breast Carcinoma

Interventions

Type	Name	Description
DRUG	Abemaciclib	CDK4 and CDK6 inhibitor, tablet taken orally
DRUG	Tamoxifen	Selective estrogen receptor modulator, taken orally per institutional standard of care
DRUG	Anastrozole	Non-steroidal aromatase inhibitor, taken orally per institutional standard of care
DRUG	Letrozole	Non-steroidal aromatase inhibitor, taken orally per institutional standard of care
DRUG	Exemestane	Steroidal aromatase inhibitor, taken orally per institutional standard of care
DRUG	LHRH Agonist	Luteinizing hormone-releasing hormone agonist), taken orally per institutional standard of care

Timeline

• Start date: 2023-10-05
• Primary completion: 2025-01-22
• Completion: 2027-01-01
• First posted: 2023-08-21
• Last updated: 2026-01-16

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study