RecruitingPhase 2NCT04563507

Combined Immunotherapies in Metastatic ER+ Breast Cancer

CIMER: Combined Immunotherapies in Metastatic ER+ Breast Cancer


Sponsor

Weill Medical College of Cornell University

Enrollment

102 participants

Start Date

Nov 12, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

Women with Hormone Receptor (HR)+ Human Epidermal growth factor Receptor (HER)2- metastatic breast cancer are eligible to a randomized trial. Patients receiving standard first line therapy for metastatic HR+ Breast cancer(BC) (letrozole+palbociclib) are randomly assigned to also receive Stereotactic Body Radiation Therapy(SBRT) to each metastatic lesion.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study tests adding immunotherapy (checkpoint inhibitors) to standard hormone-blocking treatment with CDK4/6 inhibitors (drugs that slow cancer cell division) in patients with hormone receptor-positive, HER2-negative metastatic breast cancer. **You may be eligible if...** - You are 18 or older with hormone receptor-positive (HR+), HER2-negative metastatic breast cancer - You have 5 or fewer measurable sites of disease - You are eligible for treatment with a CDK4/6 inhibitor plus an aromatase inhibitor - You are pre- or post-menopausal (male patients are also eligible) - Your cancer has progressed on at least one prior hormone therapy **You may NOT be eligible if...** - You have more than 5 sites of measurable disease - You have had more than one prior line of systemic therapy for metastatic disease - You have uncontrolled brain metastases - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONStereotactic 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

DRUGLetrozole 2.5Mg Tab

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

DRUGPalbociclib 125mg

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


Locations(3)

Weill Cornell Medicine

New York, New York, United States

Brooklyn Methodist Hospital - NewYork Presbyterian

New York, New York, United States

New York Presbyterian Hospital - Queens

New York, New York, United States

View Full Details on ClinicalTrials.gov

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NCT04563507


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