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

NCT06001762 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-01-16

No results posted yet for this study

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)

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Erica Mayer, MD, MPH · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-05
Primary Completion
2025-01-22
Completion
2027-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06001762 on ClinicalTrials.gov