Actively Recruiting
Converting HR+ Breast Cancer Into an Individualized Vaccine
Led by Weill Medical College of Cornell University · Updated on 2026-01-28
100
Participants Needed
8
Research Sites
406 weeks
Total Duration
On this page
Sponsors
W
Weill Medical College of Cornell University
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Converting HR+ Breast Cancer Into an Individualized Vaccine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Post-menopausal female aged 18 years or older (defined as either at least 2 years without menstrual period, or age over 50 with serological evidence, or hysterectomized with FSH confirmation)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Biopsy confirmed diagnosis of estrogen receptor positive (ER+) and/or progesterone receptor positive (PR+ or PR-) and HER2-negative breast cancer
- Clinical stage I (>1.5 cm if no lymph node involvement) to stage III breast cancer as per AJCC 8th edition
- Ability to understand and provide written informed consent
- Adequate bone marrow reserve and liver function with specified blood count and organ function levels
You will not qualify if you...
- Active connective tissue disorders requiring flare therapy such as lupus or scleroderma
- Current use of systemic chemotherapy, endocrine therapy, or HER2-targeted therapy
- Previous surgical excision of breast cancer
- Prior radiotherapy to the same breast
- Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 agents or other T-cell receptor targeted agents
- Unable to obtain histological confirmation of breast cancer
- Receipt of live vaccines within 30 days prior to first study drug dose
- Participation in another investigational study or device trial within 4 weeks prior to study drug
- Diagnosis of immunodeficiency or chronic systemic steroid or immunosuppressive therapy within 7 days prior to study drug
- Known second active malignancy requiring treatment within past 3 years, except certain skin or in situ cancers
- Severe hypersensitivity to pembrolizumab or its components
- Active autoimmune disease requiring systemic treatment in past 2 years
- History or current pneumonitis requiring steroids
- Active infection requiring systemic therapy
- Known HIV infection
- Known active Hepatitis B or Hepatitis C infection
- Known active tuberculosis infection
- Psychiatric or substance abuse disorders interfering with study cooperation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Withdrawn
2
Icahn School of Medicine at Mt Sinai
New York, New York, United States, 10027
Withdrawn
3
New York Presbyterian Hospital - Queens
New York, New York, United States, 10065
Actively Recruiting
4
Weill Cornell Medicine New York Presbyterian Hospital
New York, New York, United States, 10065
Actively Recruiting
5
Brooklyn Methodist Hospital - NewYork Presbyterian
New York, New York, United States, 11215
Actively Recruiting
6
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Withdrawn
7
UT Southwestern Medical Center
Dallas, Texas, United States, 75390-9179
Actively Recruiting
8
Houston Methodist Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
F
Fabiana Gregucci, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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