Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT03804944
PHASE2

Converting HR+ Breast Cancer Into an Individualized Vaccine

Sponsor: Weill Medical College of Cornell University

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2020-03-17

Completion Date

2027-12-31

Last Updated

2026-01-28

Healthy Volunteers

No

Conditions

Interventions

RADIATION

Focal 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).

DRUG

Pembrolizumab (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.

BIOLOGICAL

CDX-301

Ftl-3 ligand, self-administered by subcutaneous injections at week 1, daily, for 5 consecutive days.

Locations (8)

Cedars-Sinai Medical Center

Los Angeles, California, United States

Icahn School of Medicine at Mt Sinai

New York, New York, United States

New York Presbyterian Hospital - Queens

New York, New York, United States

Weill Cornell Medicine New York Presbyterian Hospital

New York, New York, United States

Brooklyn Methodist Hospital - NewYork Presbyterian

New York, New York, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Houston Methodist Cancer Center

Houston, Texas, United States