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Pembrolizumab (Keytruda) and Stereotactic Radiosurgery of Selected Brain Metastases in Breast Cancer Patients

This Phase l/ll trial is for women who have at least two brain metastases. Pembrolizumab (Keytruda) will be given every three weeks but radiosurgery will be given to only one of the brain metastases so that a comparison can be made of the effect of Pembrolizumab on brain metastases with and without radiosurgery. Pembrolizumab is an immunotherapy drug that has been approved for melanoma and other cancers. It has been shown to penetrate the blood-brain barrier. Previous radiosurgery is permitted if it was not given to the two regions that are the target of the study. Enrollees are not permitted to have had whole-brain radiotherapy. The size of the two target lesions must meet the Resist 1.1 criteria and must be no great than 4 cm.

T-DM1 Alone Versus T-DM1 and Metronomic Temozolomide in Secondary Prevention of HER2 Positive Breast Cancer Brain Metastases Following Stereotactic Radiotherapy

The purpose of this novel study is to see if brain metastases in women with HER2 positive metastatic breast cancer can be prevented from recurring after being treated with stereotactic radiotherapy or surgical removal. It is a three-arm Phase l/ll study. The first arm is a Phase l study of T-DM1 (Kadclya) plus escalating doses of metronomic temozolomide (Temodar), a chemotherapeutic drug used in the treatment of cancer of the brain. The Phase ll study compares T-DM1 alone to T-DM1 plus metronomic temozolomide. A metronomic dose is much smaller than a usual dose, but delivered more frequently. Patients with previous treatment of whole-brain radiation or who have leptomeningeal disease are excluded from this study.  

Etirinotecan Pegol for brain metastases 
From ASCO 2017 (American Society of Clinical Oncology annual meeting): etirinotecan pegol (brand name: Onzeald) is a long acting form of the chemotherapeutic drug irinotecan, a topoisomerase I-inhibitor (Topo I) inhibitor. Targeted to accumulate specifically in tumor tissue (including the brain), the BEACON study of 853 women with metastatic breast cancer included 67 women with brain metastases. In these 67 women, Onzeald showed a median overall survival benefit of 5.2 months when compared to physician's choice of any of the following drugs: Halavan (eribulin), Navelbine (vinorelbine)  Gemzar (gemcitabine), Abraxane (nab-paclitaxel), Ixempra (ixabepilone) or Taxotere (docetaxel).  At 12 months 44.4% of those receiving etirinotecan pegol (Onzeald) were still alive versus 19.4% for the other drugs chosen by physicians. There was also less toxicity in patients taking Onzeald, due to the targeted release of the drug.  Nektar, the company that makes Onzeald, is currently enrolling patients who have been treated for brain metastases in a Phase III trial.
Intrathecal Herceptin for the treatment of leptomeningeal metastases
Herceptin (trastuzumab) delivered directly into the ventricles of the brain by intrathecal infusion, or by lumbar puncture, may offer new hope for patients with HER2+ leptomeningeal disease, where the cancer has spread to the fluid surrounding the brain and spinal cord.  Two Phase I/II trials are testing the dose and safety of this treatment, after a number of successful case reports have documented success with this approach.  You can find the trials HERE
Drug May Reduce Cognitive Decline Following Radiation for Brain Metastases  (From the NCI Bulletin, October 28, 2012)

 A drug already approved to help improve cognition in some patients with dementia may limit declines in memory and cognitive function in patients who are undergoing whole-brain radiation therapy (WBRT) to treat cancer that has spread to the brain. Results from a clinical trial to test the drug, memantine(Namenda), in patients with brain metastases were presented October 28 at the American Society for Radiation Oncology (ASTRO) annual meeting.

Please see this important clinical study in our Available Clinical Trials listing.

A Message from Lilla Romeo, 2008
I would like to personally welcome you to the website. My name is Lilla Romeo, and I am one of the three breast cancer advocates working with the research Center of Excellence (COE) devoted to the study of brain metastases that is responsible for this website. Until a few months ago I knew very little about brain metastasis. Like everyone else, and possibly you, I shied away from too much information. I didn’t want to frighten myself or tempt fate in any way. The less I knew, the more unlikely it would be to happen to me.
I was originally diagnosed with breast cancer 13 years ago, in 1995. Five years later, while still taking Tamoxifen, I suffered a recurrence. I have now been metastatic for 8 years. I’ve taken the usual mets roller coaster ride that most of you have experienced. As we work our way through treatment after treatment, wondering how many more are out there and hoping that even more are in the pipeline, we come to feel as though we are constantly buying time. After a while we become very tuned into our own bodies.
It was because of a few unusual symptoms, that several months ago I requested a brain scan. By the time the date arrived for the scan, the symptoms, along with my fears, had disappeared. Imagine my surprise when the next day my oncologist called to say that they had found 2 tiny spots on my brain. The news was devastating. While breast cancer is every woman’s nightmare, and metastasis is the nightmare of everyone who has breast cancer, brain metastasis is the nightmare of everyone who has metastatic disease. It was so frightening that I couldn’t speak to anyone about it. I could barely allow myself to think about it. None of this is news to you. You wonder how many tears you can actually shed. You wonder if you will ever feel like your old self again and if your friends and family will ever think of you in the same way. You wonder if you will lose the person you are. It is the most terrifying diagnosis anyone can have, even those of us who are used to bad news.
I was scheduled for Gamma Knife (stereotactic radiosurgery) a few days later. You can read what my treatment was like in Talking about Treatments.
But we still know far too little about brain mets. We don’t even know with certainty whether chemotherapy gets through the blood brain barrier and to the brain. Current treatments remain few in number and uncertain in effect.
Research, including this Center of Excellence (COE) for the prevention and eradication of brain metastasis, is of critical importance. We want the breast cancer community to understand that it can’t be just about finding “the Cure.” The real killer is metastatic disease, and the most pernicious of all is brain mets. While we continue to search for the cure, we must keep fighting for more research funding to study metastatic breast cancer and brain mets in particular.
While the fear of brain mets still lives within me, I now realize that avoidance is counterproductive. We must make our voices heard. We’re in this together. It can happen to anyone. Let’s join together to make sure it stops here and doesn’t happen to our daughters.
NOTE: Lilla Romeo died of breast cancer in June, 2010. Her contributions to this website, including the new Spanish language translation, continue to make a difference. Read more about Lilla...
Lilla Romeo, Musa Mayer and Helen Schiff
The COE Advocates - December 2008
Lilla Helen Musa

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 The materials in the Brain and CNS Metastases and Treatments sections have been medically reviewed by physicians who are part of our Center of Excellence.

All information on this website is intended for general knowledge only and is not a substitute for medical advice or medical treatment. We intend the information on this website to support, not replace, the relationship that exists between you and your doctor. 

Dr. Patricia Steeg and Kevin Camphausen are employees of the intramural program of the National Cancer Institute.  They participate in the Center of Excellence as part of their official government duty.  Their viewpoints expressed do not represent the National Cancer Institute.

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