Featured Clinical Trials

This clinical trial is trying to determine if adding a drug with excellent brain penetration to your current therapy will control your brain metastases for longer and prolong the amount of time until another brain metastases occurs. This trial is for patients who have HER2-Positive MBC. It is a single-arm trial, meaning that all patients on the trial will receive the trial drug, Tucatinib, in addition to their standard of care treatment.

The trial is investigating the question of whether adding Tucatinib to your current therapy will help prolong the amount of time until another brain metastases occurs compared to historical data.

Read more about the BRIDGET clinical trial here.

Watch the video below to hear Dr. Sarah Sammons, a breast medical oncologist at Dana-Farber Cancer Institute at Harvard Medical School, discuss the BRIDGET Trial.  

This clinical trial is trying to determine if the administration of a novel antibody-drug conjugate, that selectively delivers a highly potent chemotherapy to tumor cells, will result in meaningful clinical activity for treating breast cancer that has spread to the brain or to the leptomeninges. The trial enrolls patients that have HER2-negative breast cancer (the most common subtype), which includes both triple-negative tumors and hormone receptor positive tumors. It is a single-arm trial, meaning that all patients on the trial will receive the study drug, named datopotamab deruxtecan (or Dato-DXd) across the U.S. in the summer of 2024.

Read more about the DATO-Base trial here.

Watch the video below to hear Dr. Paolo Tarantino, medical oncologist and advanced research fellow in the Breast Oncology Program at Dana-Farber Cancer Institute and Harvard Medical School, discuss the DATO-Base trial.

NRG-BN014: A PHASE III RANDOMIZED CLINICAL TRIAL OF PROTON CRANIOSPINAL IRRADIATION VERSUS INVOLVED-FIELD RADIOTHERAPY FOR PATIENTS WITH BREAST CANCER OR NONSMALL CELL LUNG CANCER LEPTOMENINGEAL METASTASIS (RADIATE-LM)

This is a national, randomized trial for patients with breast cancer or NSCLC LM. Patients will be randomized to either proton craniospinal irradiation versus involved-field radiotherapy. The primary endpoint of the study is overall survival. Please see this patient webpage for more information.

Read more about the NRG BN014 RADIATE-LM clinical trial here.

Watch the video below to hear Dr. Jonathan Yang, Radiation Oncologist at New York University School of Medicine, discuss the NRG BN014 RADIATE-LM clinical trial. 

The REMASTer clinical trial is designed to evaluate the optimal timing and uses of laser interstitial thermal therapy for brain metastases. Laser interstitial thermal therapy, or “LITT” for short, is a minimally invasive surgical procedure that uses heat from a laser fiber to ablate and kill lesions within the brain. The incision for LITT is less than 1 cm, and patients typically go home less than 24 hrs after the procedure. LITT has gained increasing usage for brain metastases that recur after radiation therapy, as well as for radiation necrosis.

While LITT continues to gain popularity, many questions remain, such as: 1) whether it should be used either after or instead of medical therapy for radiation necrosis; and 2) whether recurrent metastases should receive repeat radiation following LITT. The REMASTER clinical trial is aimed at answering these important questions so that doctors can maximize both therapeutic success, as well as patient quality of life. Currently, the trial is open at both Duke and Wake Forest Universities in North Carolina, but it is anticipated to open up more widely across the U.S. in the summer of 2024.

Read more about the REMASTer clinical trial here.

Watch the video below to hear Dr. Peter Fecci, neurosurgeon at Duke University Medical Center, discuss the REMASTer Trial. 

In the ReSPECT-LM clinical trial by Plus Therapeutics, doctors will give Leptomeningeal Metastases patients a single dose of a novel radiotherapeutic known as Rhenium (186Re) Obisbemeda through a small catheter placed under the patient’s scalp. This drug will be administered in less than 5 minutes in a hospital setting and the patient will go home the same day. More information can be found at respect-trials.com/lm.

Read more about the trial here.

Watch the video below to hear Priya Kumthekar, Neuro-Oncologist at Northwestern Medicine, discuss the ReSPECT-LM Clinical Trial.

The overall goal of this research study is to determine whether screening MRIs of the brain can help find brain metastases from breast cancer, if present. Current guidelines do not recommend MRIs of the brain for the management of patients with metastatic or inflammatory breast cancer, due to a lack of studies on the topic, but MRIs are standard in patients with other types of cancer (such as lung cancer and melanoma). It is possible that screening MRIs may prevent neurologic symptoms that could otherwise develop and/or indicate that less aggressive brain-directed management would be appropriate.

Read more about the trial here.

Watch the video below to hear Dr. Ayal Aizer, Radiation Oncologist at Dana-Farber Cancer Institute, discuss the Screening MRI of the Brain in Patients with Metastatic or Inflammatory Breast Cancer: A Prospective Study.