Ignite Creation Date:
2024-05-06 @ 12:37 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03804944
Status:
RECRUITING
Last Update Posted:
2024-03-25
First Post:
2019-01-09
Brief Title:
Converting HR Breast Cancer Into an Individualized Vaccine
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
Converting HR Breast Cancer Into an Individualized Vaccine
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CBCV
Brief Summary:
Newly diagnosed post-menopausal women with clinical stage II-III HRHER2- 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
Detailed 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 81012 at dose of 8 Gy x 3 fractions every other day 4 Letrozole Femara Novartis 25 mg tabs once a day daily for 4 months until surgery and thereafter is decided by the treating physician
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None