Actively Recruiting
Immunologic Targeting of ESR1 Receptor for Hormone Receptor Expressing Metastatic Breast Cancer
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2025-12-04
18
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
T
The V Foundation for Cancer Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a pilot study to determine feasibility and safety of the combination of Dendritic Cell (DC1) vaccines and elacestrant in patients with hormone positive HER2 negative metastatic breast cancer.
CONDITIONS
Official Title
Immunologic Targeting of ESR1 Receptor for Hormone Receptor Expressing Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Histologically or cytologically confirmed hormone positive, HER2 negative metastatic breast cancer
- Estrogen or progesterone receptor expression of 1% or more by immunohistochemistry
- HER2 negative by ASCO/CAP criteria
- Presence of ESR1 mutation detected by tissue or blood genomic profiling
- Previously treated with at least one line of endocrine therapy and a CDK 4/6 inhibitor in the metastatic setting
- Measurable or evaluable disease by RECIST v1.1 imaging
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Ability to understand and willingness to sign informed consent
- Ability to read and speak English or Spanish
- Adequate organ and marrow function including specified blood counts and liver and kidney tests
- Negative pregnancy test for pre-menopausal women of childbearing potential
- Agreement to use adequate contraception if pre-menopausal and sexually active with a male partner
- Inclusion of patients from all races and ethnic groups
- Willingness to comply with all study procedures and availability for the study duration
- Ability to have a legally authorized representative sign consent if needed
- Patients with treated and stable brain metastases without progression within 2 months prior to enrollment
You will not qualify if you...
- Pregnant or breastfeeding women
- Prior treatment with elacestrant
- History of allergic reactions to study drugs
- Active, progressing, or newly diagnosed central nervous system metastases
- Treatment with investigational drugs within 21 days before study drug administration or during the study
- Less than 14 day washout from previous anticancer therapies including chemotherapy, hormone therapies, and targeted agents
- Diagnosis or treatment for another systemic malignancy within 2 years or residual disease from prior malignancy, excluding non-melanoma skin cancer or carcinoma in situ fully resected
- Uncontrolled illnesses such as infections, heart failure, unstable angina, cardiac arrhythmias, or psychiatric/social conditions limiting compliance
- Advanced symptomatic visceral spread with risk of life-threatening complications
- Known HIV infection or acquired immunodeficiency syndrome
- Active infections including tuberculosis, hepatitis B or C, except resolved or controlled cases as specified
- Use of immunosuppressive medication within 14 days before study drugs except specified exceptions
- Inability to comply with protocol requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
Research Team
T
Taylor Lewis Whann
CONTACT
A
Aixa Soyano Muller, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here