A study comparing the effects of different hypo-fractionated radiation therapy (RT) in post-menopausal patients with early stages of breast cancer
N/A
Trial Summary
This study looks at the effect of stereotactic radiosurgery (SRS) infused with a drug called pembrolizumab in treating breast cancer patients with a certain kind of brain metastases. Pembrolizumab is a drug that helps the immune system recognize and attack cancer cells, while SRS is a radiation therapy that targets and destroys cancer cells. In other words, pembrolizumab and SRS used together could help boost the immune system’s ability to fight cancer by directly targeting and destroying cancer cells. The study will assign patients with metastatic breast cancer with certain brain metastases conditions to receive the pembrolizumab and SRS treatment.
Trial Design
100 patients who are post-menopausal with early-stage of breast cancer will be studied for 5 months – with 4 months of active study intervention and 1 month of follow-up. Patients will be randomly assigned into 4 groups differing by combinations of radiotherapy and immunotherapy.
Inclusion Criteria
1. Currently post-menopausal
2. 18 Years to 90 Years
3. Diagnosed with ER+HER2- breast cancer
4. Are female
Exclusion Criteria
1. Are pre-menopausal
2. Have connective tissue disorders
3. Received radiotherapy for the same breast
4. Received a live vaccine within 30 days prior to the first dose of study drug
Exclusion criteria are conditions or characteristics if they apply to you, may likely make you ineligible to participate in the study.
Inclusion criteria is a checklist of items, if they apply to you, may make you eligible to be included for the study.