NCT06678269View on ClinicalTrials.gov

A Study of Abemaciclib and Radiation Therapy in People With Metastatic Breast Cancer

PHASE1RecruitingINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

November 15, 2024

Primary Completion Date

November 30, 2028

Study Completion Date

November 30, 2028

Conditions
Metastatic Breast CancerStage IV Breast CancerBreast CancerBreast Cancer Stage IVBreast Cancer MetastaticHER2-negative Breast CancerHER2 Negative Breast CarcinomaHormone-receptor-positive Breast Cancer
Interventions
DRUG

Abemaciclib

The dose escalation portion of the study, a 3+3 design will be used. Once the MTD of Abemaciclib is reached, the phase Ib expansion portion will enroll up to 10 additional patients also requiring palliation to bone metastases

RADIATION

Radiation Therapy

27Gy in 3 daily fractions or 30Gy in 5 daily fractions completed entirely within 28 days of simulation via stereotactic body radiotherapy (SBRT).

Trial Locations (7)

10065

RECRUITING

Memorial Sloan Kettering Cancer Center (All protocol activites), New York

10604

RECRUITING

Memorial Sloan Kettering Westchester (All Protocol Activities), Harrison

11553

RECRUITING

Memorial Sloan Kettering Nassau (All protocol activities), Rockville Centre

11725

RECRUITING

Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities ), Commack

07920

RECRUITING

Memorial Sloan Kettering at Basking Ridge (All protocol activities), Basking Ridge

07748

RECRUITING

Memorial Sloan Kettering Monmouth (All Protocol Activities), Middletown

07645

RECRUITING

Memorial Sloan Kettering Bergen (All Protocol Activities), Montvale

All Listed Sponsors
collaborator

Eli Lilly and Company

INDUSTRY

lead

Memorial Sloan Kettering Cancer Center

OTHER