OncoMatch/Clinical Trials/NCT04348747
Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab for the Treatment of Brain Metastasis From Triple Negative Breast Cancer or HER2+ Breast Cancer
Is NCT04348747 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Anti-HER2/HER3 Dendritic Cell Vaccine and Pembrolizumab for anatomic stage iv breast cancer ajcc v8.
Treatment: Anti-HER2/HER3 Dendritic Cell Vaccine · Pembrolizumab — This phase IIa trial studies how well dendritic cell vaccines against Her2/Her3 and pembrolizumab work for the treatment of triple negative breast cancer or HER2+ breast cancer or HER+ Breast cancer that has spread to the brain (brain metastasis). Dendritic cell vaccines work by boosting the immune system (a system in the body that protect against infection) to recognize and destroy the cancer cells. . Pembrolizumab is an "immune checkpoint inhibitor" which is designed to either "unleash" or "enhance" the cancer immune responses that already exist by either blocking inhibitory molecules" or by activating stimulatory molecules. Giving dendritic cell vaccines and pembrolizumab may shrink the cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Tumor Agnostic
Triple-Negative Breast Cancer
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC 3+ or ISH positive)
HER2 testing should be performed on the invasive component using a validated immunohistochemistry (IHC) or in situ hybridization (ISH) assay
Required: HER2 (ERBB2) wild-type (IHC 0 or 1+ or ISH negative)
triple negative breast cancer (TNBC) (estrogen receptor [ER] =< 1%, progesterone receptor [PR] =< 1% HER2 negative)
Required: ESR1 wild-type (ER <= 1%)
triple negative breast cancer (TNBC) (estrogen receptor [ER] =< 1%, progesterone receptor [PR] =< 1% HER2 negative)
Required: PR (PGR) wild-type (PR <= 1%)
triple negative breast cancer (TNBC) (estrogen receptor [ER] =< 1%, progesterone receptor [PR] =< 1% HER2 negative)
Disease stage
Required: Stage IV (AJCC v8)
Metastatic disease required
Anatomic Stage IV Breast Cancer AJCC v8; Measurable brain disease as per RANO-BM criteria modified to include the cut off point of 0.5 cm or higher
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy or targeted small molecule therapy
Exception: except treatment mentioned in inclusion criteria 17
Has had prior chemotherapy or targeted small molecule therapy (except treatment mentioned in inclusion criteria 17) within 4 weeks or 5 half-lives (whichever is sooner) prior to start of treatment (first DC vaccine) or who has not recovered (i.e., <= grade 1 or at baseline) from adverse events due to a previously administered agent.
Cannot have received: investigational agent or device
may not have participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of DC vaccine treatment
Cannot have received: live vaccine or live-attenuated vaccine
Exception: seasonal influenza vaccines for injection and killed vaccines allowed
Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Seasonal influenza vaccines for injection are allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed. Administration of killed vaccines is allowed.
Cannot have received: radiotherapy
Exception: palliative radiation (<= 2 weeks of radiotherapy) to non-CNS disease allowed with 1-week washout
Has received prior radiotherapy within 2 weeks of start of study treatment with dendritic cell (DC) vaccine and/or has received SRS <2. weeks prior to the administration of the first DC vaccine dose. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (<= 2 weeks of radiotherapy) to non-CNS disease
Cannot have received: blood transfusion
Has received a blood transfusion in the two weeks prior to leukapheresis
Lab requirements
Blood counts
Hemoglobin >= 9 g/dL or >= 5.6 mmol/L; Leukocytes >= 3 x 10^9/L; ANC >= 1.5 x 10^9/L; Platelets >= 100 x 10^9/L
Kidney function
Creatinine <= 1.5 x ULN OR CrCl >= 30 mL/min for participant with creatinine levels >1.5 x ULN
Liver function
Total bilirubin <= 1.5 x ULN OR direct bilirubin <= ULN for participants with total bilirubin levels > 1.5 x ULN; AST/ALT <= 2.5 x ULN (<= 5 x ULN for participants with liver metastases)
Patients must have adequate organ and marrow function as defined below (specimens must be collected within 10 days prior to the start of study treatment): Hemoglobin >= 9 g/dL or >= 5.6 mmol/L; Leukocytes: >= 3 x 10^9/L; Absolute neutrophil count: >= 1.5 x 10^9/L; Platelets: >= 100 x 10^9/L; Total bilirubin: <= 1.5 x ULN OR direct bilirubin <= ULN for participants with total bilirubin levels > 1.5 x ULN; AST/ALT: <= 2.5 x ULN (<= 5 x ULN for participants with liver metastases); Creatinine OR Measured or calculated creatinine clearance: <=1.5 × ULN OR >=30 mL/min for participant with creatinine levels >1.5 × ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Moffitt Cancer Center · Tampa, Florida
- Roswell Park Cancer Institute · Buffalo, New York
- University of Virginia Comprehensive Cancer Center · Charlottesville, Virginia
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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