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A Multicenter Phase II Study of Vaccines to Prevent Recurrence in Patients with HER-2 Positive Breast Cancer

Investigating the Safety and Effects of an Investigational Vaccine on Breast Cancer Recurrence

Recruiting
18 years and older
All
Phase N/A

This study investigates the safety of an investigational vaccine in patients with HER2 positive breast cancer. HER2 positive breast cancer is a type of breast cancer that tests positive for a protein called human epidermal growth factor receptor 2, which promotes the growth of cancer cells. The study also looks at how the vaccine affects the time it takes for the cancer to come back, known as disease-free survival.

Participants in the study will receive either the investigational vaccine or a placebo, which is an inactive substance that looks like the investigational vaccine but does not contain any medicine. The study will monitor the health and progress of participants to evaluate the vaccine's safety and its effect on disease recurrence.

  • Who can participate: Participants must have stage I-III HER2 positive breast cancer and have completed neoadjuvant chemotherapy. They should have normal organ function and agree to use effective contraception.
  • Study details: Participants will be randomly assigned to receive either the investigational vaccine or a placebo. The study will monitor health changes and disease recurrence.
Study details
    Breast Cancer

TX10535

19 February 2024

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What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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