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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

October 5, 2023

Primary Completion Date

June 1, 2026

Study Completion Date

January 1, 2027

Conditions
Breast CancerEarly-stage Breast CancerHigh Risk Breast Carcinoma
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

Trial Locations (12)

06904

Stamford Hospital, Stamford

04412

Eastern Maine Medical Center (Northern Light), Brewer

04074

New England Cancer Specialists, Scarborough

02118

Boston Medical Center, Boston

02215

Beth Israel Deaconess Medical Center, Boston

Dana-Farber Cancer Institute, Boston

02135

Dana-Farber Cancer Institute at Steward St. Elizabeth's, Brighton

02035

Dana-Farber Cancer Institute at Foxborough, Foxborough

01844

Dana-Farber Cancer Institute at Merrimack Valley, Methuen

01757

Dana-Farber Cancer Institute at Milford, Milford

02190

Dana-Farber Cancer Institute at South Shore, South Weymouth

03053

Dana-Farber Cancer Insitute at Londonderry Hospital, Londonderry

All Listed Sponsors
collaborator

Eli Lilly and Company

INDUSTRY

lead

Dana-Farber Cancer Institute

OTHER

NCT06001762 - TRADE: Dose Escalation Tolerability of Abemaciclib in HR+ HER2- Early Stage Breast Cancer | Biotech Hunter | Biotech Hunter