Combined Immunotherapies in Metastatic ER+ Breast Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

November 12, 2020

Primary Completion Date

October 31, 2027

Study Completion Date

October 31, 2028

Conditions
Breast Cancer
Interventions
RADIATION

Stereotactic Body Radiation Therapy (SBRT) (50GY in 5 fractions)

Patients randomized to arm 2 will start letrozole alone, and add palbociclib on day 21, after completion of I-SBRT. They will undergo tumor Immunogenic-SBRT(I-SBRT) days 1-12 (+/-2 days, to enable inclusion of holidays). During the week preceding day 1, they will undergo simulation and planning for radiotherapy. Each oligometastatic lesion will be treated with I-SBRT every 48 hours. Treatment may be given daily (to keep the total I-SBRT treatment time to ≤ 12 days) and lesions targeted with I-SBRT will thus be alternated each day to accommodate for the 48 hour interval between fractions

DRUG

Letrozole 2.5Mg Tab

All patients start standard therapy with oral letrozole (Femara), day 1 of the study.

DRUG

Palbociclib 125mg

Patients randomized to arm 2 will start letrozole alone, and add palbociclib on day 21, after completion of I-SBRT.

Trial Locations (3)

10065

RECRUITING

Weill Cornell Medicine, New York

11215

RECRUITING

Brooklyn Methodist Hospital - NewYork Presbyterian, New York

11355

RECRUITING

New York Presbyterian Hospital - Queens, New York

All Listed Sponsors
lead

Weill Medical College of Cornell University

OTHER