Personalized Immunotherapy for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new personalized immunotherapy treatment for individuals with triple-negative breast cancer. Researchers aim to assess the safety and effectiveness of this treatment when combined with standard chemotherapy and pembrolizumab. The trial includes two groups: one receives the new treatment (PCI) with pembrolizumab, while the other receives an additional fusion protein to evaluate its potential to boost the immune response. This study suits those newly diagnosed with non-metastatic triple-negative breast cancer who have not yet undergone treatment. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you are currently receiving any other investigational agents or certain treatments like systemic steroids or immunosuppressive therapy.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that personalized cancer immunotherapy (PCI) for breast cancer is generally well-tolerated. Earlier research found that about 13.7% of patients experienced serious side effects related to the treatment, including immune system issues like hypothyroidism, where the thyroid gland doesn't produce enough hormones. However, many patients also showed positive results, such as tumor shrinkage, indicating a strong immune response.
As this trial is in its first phase, the main goal is to assess safety. Researchers are still learning how well patients handle the treatment. While some risks exist, the potential benefits of a strong immune response are promising.12345Why do researchers think this study treatment might be promising?
Researchers are excited about the personalized immunotherapy treatments in this trial because they offer a tailored approach to fighting breast cancer, potentially enhancing effectiveness over traditional options. Unlike standard treatments that use a one-size-fits-all method, personalized cancer immunotherapy (PCI) is designed to work with a patient’s unique immune system to better target cancer cells. Additionally, the combination with poly-ICLC and pembrolizumab represents a novel approach, harnessing multiple pathways to fight cancer more effectively. This multi-faceted strategy holds promise for improved outcomes and fewer side effects, making it a significant advancement in breast cancer treatment.
What evidence suggests that this trial's treatments could be effective for triple negative breast cancer?
Research has shown that immunotherapy can help treat triple-negative breast cancer (TNBC), especially when combined with chemotherapy. Studies indicate that combining immune checkpoint inhibitors (ICIs) with chemotherapy increases the chance of a complete response (when no cancer is found after treatment) from about 46.6% to 59.9%. In this trial, participants in Arm 1 will receive a combination of standard of care (SOC) neoadjuvant chemoimmunotherapy, personalized cancer immunotherapy (PCI), and pembrolizumab. Participants in Arm 2 will receive the same regimen with the addition of AB248. Another study highlighted that pembrolizumab, a drug that boosts the immune system, improved outcomes for breast cancer patients. Personalized cancer immunotherapy (PCI) has shown promise in early research, with some cases leading to complete tumor shrinkage in advanced breast cancer. These findings suggest that PCI, especially when combined with other treatments, could be a powerful way to tackle TNBC.36789
Who Is on the Research Team?
William Gillanders, MD
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
This trial is for individuals with triple negative breast cancer. Participants must be suitable for neoadjuvant chemoimmunotherapy, which means they'll receive treatment before surgery to shrink the tumor. Specific eligibility details are not provided but typically include factors like age, health status, and cancer stage.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Chemoimmunotherapy
Patients receive standard of care neoadjuvant chemoimmunotherapy according to the KEYNOTE 522 regimen for eight 21-day cycles
Personalized Cancer Immunotherapeutic (PCI) Treatment
Patients receive PCI + poly-ICLC and AB248, followed by surgery and additional PCI doses
Adjuvant Pembrolizumab Treatment
Patients receive 9 doses of SOC adjuvant pembrolizumab on a 21-day cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- PCI
Trial Overview
The study tests a personalized cancer immunotherapeutic (PCI) strategy in combination with various drugs including chemotherapy agents (Cyclophosphamide, Paclitaxel, Carboplatin, Doxorubicin) and immunotherapy agents (Pembrolizumab), plus an experimental CD8-selective IL-2 mutein fusion protein called AB248.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Patients will be treated with standard of care (SOC) neoadjuvant chemoimmunotherapy according to the KEYNOTE 522 regimen for eight 21-day cycles. Patients will take a 2-week drug holiday from the end of SOC neoadjuvant chemoimmunotherapy to the start of personalized cancer immunotherapeutic (PCI). Patients will receive 5 doses of the PCI + poly-ICLC on Days 1, 4, 8, 15, and 22. Patients will also receive 2 doses of AB248 on Days 8 and 22. Patients will undergo the SOC surgery on Day 29 +/- 5 days. Following surgery, patients will receive 3 additional doses of the PCI + poly-ICLC. Patients will receive 9 doses of SOC adjuvant pembrolizumab on a 21-day cycle. The PCI + poly-ICLC will be given on Days 43, 64, and 85.
Patients will be treated with standard of care (SOC) neoadjuvant chemoimmunotherapy according to the KEYNOTE 522 regimen for eight 21-day cycles. Patients will take a 2-week drug holiday from the end of SOC neoadjuvant chemoimmunotherapy to the start of personalized cancer immunotherapeutic (PCI). Patients will receive 5 doses of the PCI + poly-ICLC on Days 1, 4, 8, 15, and 22. Patients will undergo the SOC surgery on Day 29 +/- 5 days. Following surgery, patients will receive 3 additional doses of the PCI + poly-ICLC. Patients will receive 9 doses of SOC adjuvant pembrolizumab on a 21-day cycle. The PCI + poly-ICLC will be given on Days 43, 64, and 85.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
Citations
Advancements in Immunotherapy for Breast Cancer
These results highlight the effectiveness of immunotherapy in a population with historically limited treatment options and poor prognosis ...
immunotherapy-success-rate-for-breast-cancer
Immunotherapy success rate for breast cancer is 35–65% in PD-L1–positive triple-negative cases, with best outcomes using pembrolizumab plus ...
3.
clinicbarcelona.org
clinicbarcelona.org/en/news/researchers-analyse-the-efficacy-of-immunotherapy-combined-with-chemotherapy-in-the-treatment-of-early-breast-cancerResearchers analyse the efficacy of immunotherapy ...
In patients with TNBC, the combination of ICIs with chemotherapy significantly improved the pCR rate, rising from 46.6% to 59.9%. This effect ...
New data show pembrolizumab improves breast cancer ...
Among the patients who had breast-conserving surgery, 41.3% (262 patients) received pembrolizumab and 43.7% (281 patients) received placebo.
5.
cancer.gov
cancer.gov/news-events/press-releases/2022/personalized-immunotherapy-metastatic-breast-cancerExperimental immunotherapy targets metastatic breast ...
In 2018, the researchers showed that one woman with metastatic breast cancer who was treated in this trial had complete tumor shrinkage, known ...
6.
personalizedmedonc.com
personalizedmedonc.com/articles/early-results-with-immunotherapy-in-breast-cancerEarly Results with Immunotherapy in Breast Cancer
Safety was acceptable. Grade ≥3 treatment-related adverse events were reported in 13.7% of patients. Immune-related side effects (ie, hypothyroidism, ...
Real-world safety and efficacy data of immunotherapy in ...
Real-world safety and efficacy data of immunotherapy in patients with cancer and autoimmune disease: the experience of the Hellenic Cooperative Oncology Group
Personalized Immunotherapy Trials at Moffitt Cancer Center
Promising Results: Some participants experienced tumor shrinkage before chemotherapy began, indicating strong immune activation. Why This ...
Immunotherapy in breast cancer: an overview of current ...
This review provides an overview of immunotherapies currently under clinical development and updated key results from clinical trials.
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