Pembrolizumab + Radiation for Breast Cancer

(BRINK Trial)

Not yet recruiting at 1 trial location

Overseen By Kalan S Lynn, M. Sc.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Must not be taking: Corticosteroids, Immunosuppressants

Disqualifiers: Uncontrolled diabetes, Heart condition, Autoimmune, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

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. ^{1 2 3 4 5}

Why 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. ^{6 7 8 9 10}

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

Able to provide informed consent

I am 18 years old or older.

My breast cancer is not one of the excluded types.

Exclusion Criteria

My breast cancer has come back.

Any poorly controlled autoimmune conditions

I have never had a stem cell transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation and Immunotherapy

Participants receive stereotactic body radiation therapy (SBRT) and two injections of pembrolizumab

3-4 weeks

Multiple visits for radiation and pembrolizumab administration

Neoadjuvant Chemotherapy

Participants undergo standard neoadjuvant chemotherapy following radiation and immunotherapy

Approximately 5 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of pathological complete response and adverse events

6 months

Routine follow-up visits including surgery and post-operative assessments

Long-term Follow-up

Participants are monitored for long-term outcomes such as local recurrence rates and adverse events

5 years

Yearly follow-up visits including mammography

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?

Group I: SBRT with Pembrolizumab Experimental Treatment 2 Interventions

Stereotactic body radiation therapy delivered to the main breast tumour with 2 injections of pembrolizumab (Keytruda), completed prior to neoadjuvant chemotherapy.

Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07188246

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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12467722/

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 ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2021.39.15_suppl.1079

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.

4. redjournal.org redjournal.org/article/S0360-3016(24)00006-3/fulltext

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 ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0960977625005636

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- ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39282906/

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 ...

7. nejm.org nejm.org/doi/full/10.1056/NEJMoa2202809

Pembrolizumab plus Chemotherapy in Advanced Triple ... In this trial, first-line treatment with pembrolizumab–chemotherapy resulted in significantly longer overall survival than chemotherapy alone ...

8. nature.com nature.com/articles/s41591-024-03415-7

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 ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0960977625004904

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 ...

10. esmorwd.org esmorwd.org/article/S2949-8201(24)00039-0/fulltext

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).