Actively Recruiting
Combined Immunotherapies in Metastatic ER+ Breast Cancer
Led by Weill Medical College of Cornell University · Updated on 2025-12-15
102
Participants Needed
3
Research Sites
415 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Women with Hormone Receptor (HR)+ Human Epidermal growth factor Receptor (HER)2- metastatic breast cancer are eligible to a randomized trial. Patients receiving standard first line therapy for metastatic HR+ Breast cancer(BC) (letrozole+palbociclib) are randomly assigned to also receive Stereotactic Body Radiation Therapy(SBRT) to each metastatic lesion.
CONDITIONS
Official Title
Combined Immunotherapies in Metastatic ER+ Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 years or older, pre- or post-menopausal
- Metastatic breast cancer with 5 or fewer measurable disease sites by RECIST
- Eligible for treatment with CDK4/6 inhibitors plus aromatase inhibitors
- Premenopausal status defined by recent menstruation, hormonal levels, or therapy-induced amenorrhea with appropriate lab confirmation
- Post-menopausal status defined by absence of menstruation for at least 2 years, age over 50 with lab confirmation, or hysterectomy with lab confirmation
- ECOG performance status of 0 or 1
- Biopsy-proven hormone receptor-positive, HER2-negative metastatic breast cancer with ER expression over 10%
- Ability and willingness to sign informed consent
- Adequate blood counts: WBC ≥ 2000/uL, ANC ≥ 1500/µL, platelets ≥ 100,000/µL, hemoglobin ≥ 9.0 g/dL
- Adequate kidney function: creatinine or creatinine clearance ≥ 30 mL/min or ≤ 1.5 × ULN
- Adequate liver function: total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN, AST and ALT ≤ 2.5 × ULN
- Adequate coagulation parameters (INR, PT, aPTT within acceptable ranges unless on anticoagulants)
You will not qualify if you...
- Active connective tissue disorders needing flare therapy such as lupus or scleroderma
- Current use of systemic chemotherapy, endocrine therapy, or HER2-targeted therapy
- Any metastatic lesion larger than 5 cm in diameter
- Inability to obtain histologic proof of metastatic breast cancer
- Immunodeficiency or use of immunosuppressive therapy exceeding 10 mg prednisone daily within 7 days before study drug
- Known progressing second primary malignancy requiring active treatment within past 3 years (except treated skin or in situ cancers)
- Active autoimmune disease requiring systemic treatment in past 2 years
- Active infection requiring systemic therapy
- Known HIV infection
- Psychiatric or substance abuse disorders interfering with trial cooperation
- Uncontrolled brain metastases
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Weill Cornell Medicine
New York, New York, United States, 10065
Actively Recruiting
2
Brooklyn Methodist Hospital - NewYork Presbyterian
New York, New York, United States, 11215
Actively Recruiting
3
New York Presbyterian Hospital - Queens
New York, New York, United States, 11355
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
2
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