Actively Recruiting
DecipHER Trial - DC1 Tx for Early-Stage TNBC and ER Low Positive Breast Cancer
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-02-05
30
Participants Needed
1
Research Sites
213 weeks
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
T
The Shulas' Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of the study is to find out if an investigational vaccine called Dendritic Cell (DC) vaccine given together with standard of care chemotherapy drugs can help people with Triple Negative and HR low positive breast cancer.
CONDITIONS
Official Title
DecipHER Trial - DC1 Tx for Early-Stage TNBC and ER Low Positive Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with HER2-negative breast cancer
- Tumor is hormone receptor negative or low positive
- Clinical stage T1c with nodal stage N1-N2, or stage T2-4 with nodal stage N0-N2 breast cancer
- Medically and surgically appropriate for neoadjuvant chemotherapy followed by standard local therapy
- Age 18 years or older
- ECOG performance status of 0 or 1
- Normal organ and marrow function within 14 days of registration, including:
- Absolute neutrophil count ≥ 1500/µL
- Platelets ≥ 75,000/µL
- Total bilirubin ≤ 1.5 times institutional upper limit of normal (ULN), except for Gilbert's syndrome where total bilirubin < 3.0 mg/dL
- AST/ALT ≤ 3 times institutional ULN
- Creatinine ≤ 1.5 times institutional ULN
- Left ventricular ejection fraction above institutional lower limit of normal (by echocardiogram or MUGA scan)
- Female patients of childbearing potential must use dual contraception methods and have a negative serum pregnancy test at screening
- Postmenopausal women must be amenorrheic for at least 12 months naturally or surgically sterile
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior anthracycline-based chemotherapy for any cancer
- Inflammatory breast cancer
- Receiving other investigational or active antineoplastic therapies
- Uncontrolled illness such as active infection, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric/social conditions limiting compliance
- Active autoimmune disease or history of autoimmune disease affecting vital organs or requiring immune-suppressive treatment, including prolonged corticosteroid use
- Pregnant or nursing females
- Prior malignancy except adequately treated basal-cell or squamous-cell skin cancer, in situ cervical cancer, or cancer disease-free for at least 3 years
- History of HIV/AIDS
- History of acute or chronic Hepatitis B or C infection
- Received live attenuated vaccine within 30 days prior to registration
- Unable to comply with treatment schedule and study procedures
- Breast cancer-directed vaccine therapy within past 3 months
- Prior HER2- or HER3-primed dendritic cell therapy
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
R
Ricardo Costa
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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