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New treatment option for Triple Negative Breast Cancer
Official title DecipHER Trial - DC1 Tx for Early-Stage TNBC and ER Low Positive Breast Cancer
ClinicalTrials.gov ID: NCT05504707
What this study is testing
What is HER2 - primed Dendritic cells?
HER2 - primed Dendritic cells is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for triple negative breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- A diagnosis of HER2-negative breast cancer.
- Diagnosis of HR negative or HR low positive tumor.
- Clinical stage T1c, nodal stage N1-N2 or stage T2-4, nodal stage N0-N2 breast cancer.
- Participant must be medically and surgically appropriate to undergo neoadjuvant chemotherapy regimen followed by standard of care local therapy as...
- Age ≥18 years.
You likely can't join if
- Patients who received prior anthracycline-based chemotherapy for the treatment of any cancer.
- Patients with inflammatory breast cancer.
- Patients must not be receiving any other investigational agents or active antineoplastic therapies.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina...
- Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require...
- Female patients who are pregnant or nursing.
See the full eligibility criteria
- A diagnosis of HER2-negative breast cancer.
- Diagnosis of HR negative or HR low positive tumor.
- Clinical stage T1c, nodal stage N1-N2 or stage T2-4, nodal stage N0-N2 breast cancer.
- Participant must be medically and surgically appropriate to undergo neoadjuvant chemotherapy regimen followed by standard of care local therapy as determined by their treating physician.
- Age ≥18 years.
- ECOG performance status 0 or 1.
- Patients must have normal organ and marrow function, as defined below, within 14 days of registration:
- \ Absolute neutrophil count (ANC) ≥ 1500/μL
- \ Platelets ≥ 75 000/μL
- \ Total bilirubin ≤ 1.5 x institutional ULN, except patients with Gilbert's syndrome in whom total bilirubin must be \< 3.0 mg/dL
- \ AST/ALT ≤ 3 x institutional ULN
- \ Creatinine ≤ 1.5 x institutional ULN
- Left ventricular ejection fraction above institutional lower limit of normal (by echocardiogram or MUGA scan).
- Female patients of childbearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening. Acceptable methods of contraception are condoms with contraceptive foam...
- Ability to understand and the willingness to sign a written informed consent agreement prior to study registration.
- Patients who received prior anthracycline-based chemotherapy for the treatment of any cancer.
- Patients with inflammatory breast cancer.
- Patients must not be receiving any other investigational agents or active antineoplastic therapies.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations...
- Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune-suppressive treatment, including chronic prolonged systemic...
- Female patients who are pregnant or nursing.
- No other prior malignancy is allowed, except for the following: a. adequately treated basal-cell or squamous-cell skin cancer, b. in situ cervical cancer, c. or any other cancer from which the patient has been disease...
- History of testing positive for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
- History of positive test for Hepatitis B or Hepatitis C virus indicating acute or chronic infection.
- Patients who have received a live attenuated vaccine ≤ 30 days prior to registration.
- Unable to comply with the treatment schedule and study procedures for any reason.
- Previously treated with breast cancer-directed vaccine therapies in prior 3 months.
- Previously treated with any form HER2- or HER3-primed DC1 therapy.
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.