Study on HER2 Directed Dendritic Cell Vaccine with Weekly Paclitaxel, Trastuzumab, and Pertuzumab

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05325632

Provider View

This clinical trial is exploring whether adding a new vaccine, called the Dendritic Cell (DC1) vaccine, to the usual treatment before surgery can help people with HER2-positive breast cancer.

Patient Parameters

Program Overview

The aim of this study is to determine if a new vaccine, known as the Dendritic Cell (DC1) vaccine, can improve treatment outcomes when combined with standard therapy given before the main treatment for patients with HER2-positive breast cancer. This standard therapy includes the drugs Paclitaxel, Trastuzumab, and Pertuzumab.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of stage I-III HER2-positive breast cancer, with a primary tumor measuring at least 1 cm.
  • Be eligible for chemotherapy with Paclitaxel, Trastuzumab, and Pertuzumab before surgery, as decided by your doctor.
  • Be in good overall health, with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have normal organ and bone marrow function based on specific medical tests.
  • Have a normal heart function as shown by a heart scan or echocardiogram.
  • Women who can become pregnant and their male partners must agree to use effective birth control during the study. If a woman becomes pregnant or thinks she might be, she should inform her doctor immediately. Men should use a barrier method or abstain from sex during chemotherapy until surgery.
  • Be able to understand and willing to sign a consent form to participate in the study.

Exclusion Criteria

  • Have inflammatory breast cancer or advanced breast cancer that cannot be surgically removed, or if the cancer has spread to other parts of the body.
  • Be receiving any other experimental treatments for breast cancer.
  • Have a history of allergic reactions to similar vaccines or any of the chemotherapy drugs used in the study.
  • Be unable or unwilling to undergo a procedure to collect cells for the vaccine.
  • Have uncontrolled health issues, such as ongoing infections, heart failure, unstable chest pain, irregular heartbeats, or mental health conditions that would make it hard to follow the study requirements.
  • Be pregnant or breastfeeding.
  • Have a known immune deficiency or require immune-suppressing drugs for conditions like autoimmune diseases or organ transplants.

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