Now Enrolling: Novel Dendritic Cell Vaccines Immunotherapy Trial For HER2+ Breast Cancer

Dendritic cell vaccines study offers hope for a less toxic, more personalized approach for the treatment of HER2 breast cancer with less chemotherapy and better outcomes. 

Heather Han, MD, a medical oncologist at Moffitt Cancer Center and Director of Clinical Research in the Breast Oncology Program, is spearheading a novel, less-toxic immune-enhancing approach that could transform the standard of care. This study is only available at Moffitt.

The treatment utilizes HER2-primed dendritic cell vaccines, which aim to stimulate a patient’s immune system to recognize and attack breast tumors more effectively.  “Our work here marks a promising advance in the treatment of early-stage HER2-positive breast cancer,” says Dr. Han.  She added, “By harnessing a personalized, immune-enhancing approach, we are beginning to see the potential to achieve cure rates comparable to—or better than—those achieved with conventional chemotherapy, but with significantly less toxicity.”

Expanding Access Through the NATASHA Trial

Based on promising results from an earlier pilot study, NATASHA, an ongoing clinical and investigator-initiated trial (IIT) led by Dr. Han, investigates the efficacy of preoperative intratumoral dendritic cell vaccines in combination with a reduced chemotherapy regimen, aiming to minimize toxicity while maintaining effectiveness.

Preliminary imaging from NATASHA has revealed tumor shrinkage in some patients before the first dose of chemotherapy, suggesting that dendritic cell 2 vaccines alone may initiate tumor regression. Currently, Moffitt is accepting eligible HER2 breast cancer patients for this study.

Patient Eligibility Criteria

Referring providers should consider this trial for patients who meet the following criteria:

• Histologically confirmed clinical stage I–III, HER2-positive (per ASCO/CAP) invasive breast carcinoma
• Primary tumor ≥1 cm on clinical exam or imaging
• Candidate for neoadjuvant chemotherapy with paclitaxel, trastuzumab, and pertuzumab, followed by standard local therapy
• ECOG performance status of 0 or 1
• Normal organ and marrow functions per protocol guidelines
• Normal cardiac ejection fraction (by MUGA or echocardiogram)

A Scalable Future for Community Practice

Although dendritic cell vaccines require pheresis for manufacturing, this process is already widely used in transplant medicine. Once collected, cells can be processed at a central facility to produce the vaccine, which can then be shipped back to the site of care for local administration. A centralized model supports the feasible expansion of the broader implementation of dendritic cell therapies into community healthcare settings.

“Looking ahead, we see these personalized vaccines becoming a central component of neoadjuvant therapy, used alongside biologics like trastuzumab and pertuzumab or checkpoint inhibitors such as pembrolizumab,” says Dr Han. “Together, these modalities could significantly reduce the need for traditional chemotherapy.”

Refer Your Patient

To refer an eligible patient for the NATASHA trial, please email the Clinical Trial Coordinator at CTOBreast@Moffitt.org. 

References:

ASCO, American Society of Clinical Oncology; CAP, College of American Pathologists; ECOG, Eastern Cooperative Oncology Group; HER2, human epidermal growth factor receptor 2; MUGA, multigated acquisition scan.

Han H, Costa R, Armaghani A, et al. Study of HER2 directed dendritic cell (DC1) vaccine +

weekly paclitaxel, trastuzumab & pertuzumab.ClinicalTrials.gov identifier: NCT05325632.

Updated May 23, 2025. Accessed June 18, 2025.

https://www.clinicaltrials.gov/study/NCT05325632  

Han H, Costa R, Armaghani A, et al. Neoadjuvant therapy of HER2 directed conventional dendritic cell (DC1) intratumoral (IT) therapy plus weekly paclitaxel, trastuzumab, and pertuzumab in patients with HER-2 positive breast cancer: NATASHA trial. Poster presented at: 2023 ASCO Annual Meeting; June 4, 2023; Chicago, IL.