Plain-English translation of NCT06691035 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.
This early-stage trial is testing a combination approach for advanced breast cancer that has spread to other parts of the body. The study combines two treatments: , a new oral medication that blocks estrogen receptors in cancer cells, and DC1 vaccines—personalized immune cells trained to recognize and attack breast cancer. You would receive both treatments together over several months.
Some breast cancers develop mutations that make them resistant to standard hormone therapies. This trial is exploring whether the new medication combined with a personalized vaccine approach might help overcome that resistance and work better than the medication alone.
You would first have a procedure to collect immune cells from your blood. Your medical team would then prepare personalized DC1 vaccines trained to recognize your specific cancer. Starting after safety testing is complete, you would receive weekly injections of these vaccines into lymph nodes in your groin (or a tumor if accessible) for 8 weeks, alternating between two types of vaccines. You would also take the oral medication daily throughout the study and continue it afterward. You would return for additional vaccine doses every 4 weeks for 3 more months, plus regular clinic visits for monitoring.
AI-generated summary from trial data · Aug 31, 2026 · Not medical advice
United States
Phase
Safety & dosing
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
The V Foundation for Cancer Research
Enrollment target
~18 participants
Started
November 2024
Primary completion
November 2026
Age range
18 Years and older
Last updated on clinicaltrials.gov in August 2026.