DC1 dendritic-cell vaccine with chemotherapy for early-stage triple-negative and ER-low breast cancer

Phase 1 Dose-Escalation, Dose-Expansion Trial of Intratumoral HER2- and HER3-Primed Dendritic Cells Injections for the Treatment of Early-Stage TNBC and ER Low Positive Breast Cancer (DecipHER)

This trial will test whether a dendritic cell vaccine given with standard chemotherapy helps people with early-stage triple-negative or ER-low breast cancer.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Tampa, Florida)
• Trial ID: NCT05504707 on ClinicalTrials.gov

What this trial studies

This is a phase 1 trial testing HER2-primed and HER3-primed dendritic cell (DC) vaccines given together with standard neoadjuvant chemotherapy, followed by standard local therapy. The main focus is safety and tolerability of the vaccine combination, with secondary measures of immune response and preliminary measures of tumor response at surgery. Eligible patients are adults with HER2-negative, hormone receptor–negative or low-positive tumors in specified early-stage T and N categories who are fit for neoadjuvant chemotherapy and surgery. Vaccinations are administered at the cancer center alongside routine treatment visits.

Who should consider this trial

Good fit: Adults (≥18) with HER2-negative, hormone receptor–negative or low-positive early-stage breast cancer in the specified T and N stages, ECOG 0–1, with adequate organ function and cleared for neoadjuvant chemotherapy and subsequent local therapy are ideal candidates.

Not a fit: Patients with HER2-positive disease, metastatic cancer, inability to receive chemotherapy or surgery, or with poor organ function or performance status are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the vaccine could boost anti-tumor immune responses and increase the chance of complete tumor eradication at surgery, potentially lowering recurrence risk.

How similar studies have performed: Dendritic cell vaccines have generated immune responses in prior early-phase cancer trials but have not yet produced consistent large clinical benefits, so using HER2/HER3-primed DCs with neoadjuvant chemo here remains experimental.

Eligibility criteria

Inclusion 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, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal. Effective methods of contraception must be used throughout the study and for 5 months following the last dose. To show that women do not have childbearing potential, postmenopausal women must be amenorrheic for at least 12 months naturally (and not because of/following chemotherapy) or patients must be surgically sterile.
* Ability to understand and the willingness to sign a written informed consent agreement prior to study registration.

Exclusion Criteria:

* 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 that would limit compliance with study requirements.
* 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 corticosteroid use (defined as corticosteroid use lasting one month or more).
* 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 free for at least 3 years.
* 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.

Where this trial is running

Tampa, Florida

• Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)

Study contacts

• Principal investigator: Ricardo Costa, MD — Moffitt Cancer Center
• Study coordinator: Ricardo Costa

Conditions Triple Negative Breast Cancer; HER2-negative Breast Cancer; Breast Cancer