Converting HR+ Breast Cancer Into an Individualized Vaccine — CBCV  

Breast Cancer Clinical Trial

Official title: Converting HR+ Breast Cancer Into an Individualized Vaccine

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 1-5. 3. For all arms radiation therapy to the breast tumor will begin on week 2 (Day 8,10,12), at dose of 8 Gy x 3 fractions, every other day. 4. Letrozole (Femara ®, Novartis) 2.5 mg tabs, once a day, daily for 4 months, until surgery, and thereafter is decided by the treating physician. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT03804944
• Study type: Interventional
• Source: Weill Medical College of Cornell University
• Contact: Sharanya Chandrasekhar, M.S.
• Phone: 646 962-2196
• Email: shc2043@med.cornell.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: March 17, 2020
• Completion date: December 2027