CIMER: Combined Immunotherapies in Metastatic ER+ Breast Cancer

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

Age range

18–90 years

Sex

Female

Healthy volunteers

No

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.

Locations (3)