RecruitingPhase 2NCT05325632

Study of HER2 Directed Dendritic Cell (DC1) Vaccine + Weekly Paclitaxel, Trastuzumab & Pertuzumab

A Phase II Study of Human Epidermal Growth Factor Receptor 2 (HER-2) Directed Dendritic Cell (DC1) Vaccine Plus Weekly Paclitaxel, Trastuzumab and Pertuzumab in Patients With HER-2 Positive Breast Cancer

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

53 participants

Start Date

Oct 28, 2021

Study Type

INTERVENTIONAL

Conditions

HER2-positive Breast Cancer

Summary

The purpose of the study is to find out if an investigational drug called Dendritic Cell (DC1) vaccine added to standard neoadjuvant (given before main treatment) therapy can help people with HER2 (human epidermal growth factor receptor 2) positive breast cancer.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a personalized immune therapy vaccine targeting HER2 (a protein overexpressed in some breast cancers) combined with weekly paclitaxel chemotherapy in patients with HER2-expressing breast cancer. **You may be eligible if...** - You have HER2-positive or HER2-low breast cancer (overexpression confirmed) - You are eligible for paclitaxel-based chemotherapy - You are 18 or older - You have not had prior HER2-targeted immunotherapy vaccines **You may NOT be eligible if...** - You have active autoimmune disease - You are pregnant or breastfeeding - You are immunocompromised in a way that would prevent immune response to the vaccine - You have severe liver or kidney dysfunction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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