Pembrolizumab + Radiation for Breast Cancer
(BRINK Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination of treatments for certain types of breast cancer. It combines pembrolizumab, a drug that helps the immune system fight cancer, with a special type of radiation therapy before starting standard chemotherapy. The goal is to determine if this combination improves the cancer's response to treatment. This trial may suit individuals with breast cancer that can be felt by a doctor, is planned for chemotherapy, and meets specific cancer stage criteria. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using corticosteroids or immunosuppressants.
Is there any evidence suggesting that this trial's treatment is likely to be safe?
Research has shown that combining pembrolizumab with chemotherapy can improve survival rates for cancer patients compared to chemotherapy alone, suggesting it might be a beneficial part of a cancer treatment plan. However, safety remains a crucial consideration.
Studies have found that 35% of patients taking pembrolizumab experience immune-related side effects, ranging from mild to severe, with 13% facing more serious issues. This occurs because pembrolizumab enhances the immune system to fight cancer, which can sometimes lead the body to attack its own cells.
Pembrolizumab has already received approval for treating other types of cancer, providing some confidence in its safety. Nonetheless, like any treatment, it carries risks, and weighing these against potential benefits is essential. Consulting a healthcare professional about any concerns before joining a trial is always advisable.12345Why do researchers think this study treatment might be promising for breast cancer?
Unlike the standard breast cancer treatments that typically involve chemotherapy, surgery, or hormone therapy, the investigational treatment using pembrolizumab combined with stereotactic body radiation therapy (SBRT) offers a unique approach. Pembrolizumab is an immunotherapy drug that helps the immune system recognize and attack cancer cells, which differs from traditional treatments that directly target the tumor. Additionally, SBRT delivers high doses of radiation precisely to the tumor in fewer sessions, potentially leading to quicker and more targeted treatment. Researchers are excited about this combination because it could enhance the immune response while minimizing damage to surrounding healthy tissue, leading to better outcomes for patients.
What evidence suggests that this treatment might be an effective treatment for breast cancer?
Research has shown that combining pembrolizumab with stereotactic body radiation therapy (SBRT) might improve breast cancer treatment outcomes. In this trial, participants will receive SBRT directed at the main breast tumor and two injections of pembrolizumab (Keytruda) before neoadjuvant chemotherapy. Pembrolizumab aids the immune system in fighting cancer by blocking a protein called PD-1. Studies have found that pembrolizumab can extend the time patients remain without cancer progression. SBRT precisely targets tumors, potentially enhancing pembrolizumab's effectiveness. Early results suggest that this combination could improve treatment response in breast cancer patients, making it a promising option.678910
Are You a Good Fit for This Trial?
This trial is for individuals with high-risk primary breast cancer. Participants should be candidates for neoadjuvant chemotherapy and have not yet received treatment. Specific details about inclusion or exclusion criteria are not provided, but typically these would involve health status, prior treatments, and other medical conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Radiation and Immunotherapy
Participants receive stereotactic body radiation therapy (SBRT) and two injections of pembrolizumab
Neoadjuvant Chemotherapy
Participants undergo standard neoadjuvant chemotherapy following radiation and immunotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment, including evaluation of pathological complete response and adverse events
Long-term Follow-up
Participants are monitored for long-term outcomes such as local recurrence rates and adverse events
What Are the Treatments Tested in This Trial?
Interventions
- Pembrolizumab
Trial Overview
The study tests the combination of SBRT (a type of focused radiation therapy) with pembrolizumab injections before standard chemotherapy in breast cancer patients. The goal is to see if this approach can boost the immune system's response against cancer cells more effectively than current methods.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Stereotactic body radiation therapy delivered to the main breast tumour with 2 injections of pembrolizumab (Keytruda), completed prior to neoadjuvant chemotherapy.
Find a Clinic Near You
Who Is Running the Clinical Trial?
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead Sponsor
Citations
Study Details | NCT07188246 | Neoadjuvant, SBRT With ...
This study will evaluate the immune-priming effects of stereotactic body radiation therapy (SBRT) combined with intratumoural pembrolizumab in ...
The Role of Immunotherapy and Radiation Therapy in ...
With a median follow-up of 15.5 months, pembrolizumab also improved EFS (HR: 0.63), although long-term survival benefits remain under ...
A phase II trial of stereotactic radiation therapy and in situ ...
ADV/HSV-tk gene therapy followed by radiation therapy and then pembrolizumab is a well-tolerated promising treatment in heavily pretreated mTNBC patients.
Immunotherapy and Radiation Therapy Sequencing in ...
Of the 558 patients who received adjuvant pembrolizumab, 76% received RT (39% sequential, 26% concurrent), and among the 320 patients who ...
Impact of stereotactic body radiation therapy on systemic ...
Results. 3.1. Patients. We identified 246 breast cancer (BC) metastases treated with SBRT between January 2018 and December 2021 at Institut Paoli- ...
Overall Survival with Pembrolizumab in Early-Stage Triple ...
The estimated overall survival at 60 months was 86.6% (95% confidence interval [CI], 84.0 to 88.8) in the pembrolizumab-chemotherapy group, as ...
Pembrolizumab plus Chemotherapy in Advanced Triple ...
In this trial, first-line treatment with pembrolizumab–chemotherapy resulted in significantly longer overall survival than chemotherapy alone ...
Pembrolizumab and chemotherapy in high-risk, early-stage ...
In summary, the addition of pembrolizumab to neoadjuvant chemotherapy significantly improved the pathological complete response rate in patients ...
Immune-related adverse events among patients with early ...
Immune-related adverse events of any grade occurred in 35 % of patients in the pembrolizumab group, with 13 % experiencing irAEs of grade 3 or higher, and two ...
Real-world safety and effectiveness of neoadjuvant ...
Neoadjuvant chemotherapy (NAC) with the addition of pembrolizumab has become the standard of care for early-stage II-III triple-negative breast cancer (TNBC).
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