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Personalized Vaccine Immunotherapy in Combination With Checkpoint Inhibitor for Treatment of Triple Negative Breast Cancer

Exploring new vaccine treatment for triple negative breast cancer.

Recruiting
18 years and older
All
Phase 1

This study is exploring a new treatment for Triple Negative Breast Cancer (TNBC), which is a type of breast cancer that does not have three common receptors known to fuel most breast cancer growth. The study involves a personalized vaccine made from a patient's own tumor to help the immune system remember and fight the cancer. It is tested alone and with medicines called checkpoint inhibitors (like pembrolizumab or ipilimumab), which help the immune system attack cancer cells better.

  • Duration: The study has two phases. Phase Ia lasts for approximately 5 weeks, and Phase Ib can extend up to 9 cycles (each cycle is 21 days).
  • Visits: Participants will receive treatments at specified intervals and be monitored every 12 weeks for up to 2 years after treatments.
  • Risks: Potential side effects include those related to vaccines and checkpoint inhibitors, like skin reactions or immune-related symptoms.

Participants must be at least 18 years old, with a certain health status, and no severe heart, lung, or immune system conditions. This study could help in advancing cancer treatment by using personalized approaches to stimulate the immune system.

Study details
    Anatomic Stage I Breast Cancer AJCC v8
    Anatomic Stage IA Breast Cancer AJCC v8
    Anatomic Stage IB Breast Cancer AJCC v8
    Anatomic Stage II Breast Cancer AJCC v8
    Anatomic Stage IIA Breast Cancer AJCC v8
    Anatomic Stage IIB Breast Cancer AJCC v8
    Anatomic Stage III Breast Cancer AJCC v8
    Anatomic Stage IIIA Breast Cancer AJCC v8
    Anatomic Stage IIIB Breast Cancer AJCC v8
    Anatomic Stage IIIC Breast Cancer AJCC v8
    Anatomic Stage IV Breast Cancer AJCC v8
    Early Stage Triple-Negative Breast Carcinoma
    Locally Advanced Triple-Negative Breast Carcinoma
    Metastatic Triple-Negative Breast Carcinoma
    Prognostic Stage I Breast Cancer AJCC v8
    Prognostic Stage IA Breast Cancer AJCC v8
    Prognostic Stage IB Breast Cancer AJCC v8
    Prognostic Stage II Breast Cancer AJCC v8
    Prognostic Stage IIA Breast Cancer AJCC v8
    Prognostic Stage IIB Breast Cancer AJCC v8
    Prognostic Stage III Breast Cancer AJCC v8
    Prognostic Stage IIIA Breast Cancer AJCC v8
    Prognostic Stage IIIB Breast Cancer AJCC v8
    Prognostic Stage IIIC Breast Cancer AJCC v8
    Prognostic Stage IV Breast Cancer AJCC v8
    Recurrent Breast Carcinoma
    Unresectable Triple-Negative Breast Carcinoma

NCT06324240

Emory University

7 March 2026

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

Why should I take part in a clinical trial?

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