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Converting HR+ Breast Cancer Into an Individualized Vaccine

NCT03804944 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-01-28

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Celldex Therapeutics

    collaborator INDUSTRY

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Silvia Formenti, M.D. · Weill Cornell Medicine - New York Presbyterian Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-17
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03804944 on ClinicalTrials.gov