Dendritic Cell Vaccine Offers Hope for HER2-Positive Breast Cancer

In the rapidly evolving landscape of breast cancer treatment, Dr. Hyo Han, a medical oncologist in the Breast Oncology Program at Moffitt Cancer Center, is spearheading a novel approach to early-stage HER2-positive breast cancer—one that could transform the standard of care by reducing reliance on toxic chemotherapy and enhancing long-term outcomes through immune-based therapy.

The treatment centers on HER2-primed dendritic cell vaccines, which aim to stimulate a patient’s immune system to recognize and attack breast tumors more effectively.

“We envision a future where these personalized vaccines are an integral part of neoadjuvant therapy, working in synergy with biologics like trastuzumab, pertuzumab, or checkpoint inhibitors such as pembrolizumab,” says Dr. Han. “This could significantly reduce the need for traditional chemotherapy while preserving or enhancing cure rates.”

This study is currently available only at Moffitt, offers a novel, less toxic, immune-enhancing treatment approach for early-stage HER2+ breast cancer patients.  

Expanding Access Through the NATASHA Trial

These promising results from an earlier pilot study have paved the way for NATASHA, an ongoing clinical trial led by Dr. Han. NATASHA explores the efficacy of preoperative intratumoral dendritic cell vaccines combined with a de-escalated chemotherapy regimen, minimizing toxicity without compromising effectiveness.

Preliminary imaging from NATASHA has revealed tumor shrinkage in some patients following dendritic cell vaccine therapies in combination with HER2-targeted agents before the first dose of chemotherapy, suggesting that immunotherapy alone may initiate tumor regression.

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 function per protocol guidelines
• Normal cardiac ejection fraction (by MUGA or echocardiogram)

A Scalable Future for Community Practice

Though dendritic cell vaccines require pheresis for manufacturing, this process is already widely used in transplant medicine. The vaccine can be produced at a central facility and shipped back for local administration, making this therapy feasible for expansion into community settings.

Currently, Moffitt is accepting eligible HER2 breast cancer patients for this study.

Refer Your Patient

For eligibility confirmation or to refer a patient to the NATASHA trial, call 813-736-1346 or 1-844-255-7558 (toll-free) or submit a clinical trials inquiry form.