Converting HR+ Breast Cancer Into an Individualized Vaccine
Weill Medical College of Cornell University
Summary
Newly diagnosed post-menopausal women with clinical stage II-III, HR+HER2- breast cancer are eligible to a randomized trial, concurrently open at five US academic institutions. Patients receiving 4 months of standard neoadjuvant hormonal therapy with letrozole are randomly assigned to one of 4 arms of a trial testing focal hypo-fractionated RT alone or with immunotherapy combinations.
Description
Patients will be on the study for a total of 5 months, this includes 4 months on active study intervention, with breast surgery at week 16 and one month follow up period, after surgery. Patients will be randomly assigned to one of these 4 arms - 1. Anti-PD1 antibody pembrolizumab (Keytruda, Merck) will be infused day 12, at the standard dose of 200 mg IV over 30 minutes, repeated every 3 weeks until disease progression or unacceptable toxicity. 2. FLT3L (CDX-301, the recombinant human protein by Celldex) will be self-administered subcutaneously, in 5 consecutive daily injections, week 1, day 1…
Eligibility
- Age range
- 18–90 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Post-menopausal female ≥ 18 years of age (Post-menopausal status defined as either 1) at least 2 years without menstrual period or 2) or patients older than 50 with serological evidence of post-menopausal status or 3) hysterectomized patients of any age with FSH confirmation of post-menopausal status. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Biopsy proven diagnosis of ER+ PR+ or PR- HER2- breast cancer. * Clinical stage I(\>1.5cm, if N0) - III breast cancer, as per AJCC staging 8th edition. * Patient needs to be able to understand and demonstr…
Interventions
- RadiationFocal Radiation therapy
Focal hypo-fractionated radiation therapy 8 Gy x 3 fractions, starting day 8, every other day (M/W/F or W/F/M or F/M/W).
- DrugPembrolizumab (200mg IV for 30 minutes
Pembrolizumab, on day 12 (last day of radiotherapy), infused over 200mg IV over 30 minutes and then repeated every 3 weeks until disease progression or unacceptable toxicity.
- BiologicalCDX-301
Ftl-3 ligand, self-administered by subcutaneous injections at week 1, daily, for 5 consecutive days.
Locations (8)
- Cedars-Sinai Medical CenterLos Angeles, California
- Icahn School of Medicine at Mt SinaiNew York, New York
- New York Presbyterian Hospital - QueensNew York, New York
- Weill Cornell Medicine New York Presbyterian HospitalNew York, New York
- Brooklyn Methodist Hospital - NewYork PresbyterianNew York, New York
- UPMC Hillman Cancer CenterPittsburgh, Pennsylvania