Featured Clinical Trials
MBCBrainMets.org is currently featuring clinical trials led by our Medical Advisory Board.
DATO-Base 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.
Dendritic Cell Vaccine for Metastatic Triple Negative or HER2+ Breast Cancer With Leptomeningeal Disease
The trial NCT05809752 is a Phase I study evaluating the safety and best dose of a dendritic cell vaccine for patients with metastatic triple-negative or HER2-positive breast cancer that has spread to the meninges (leptomeningeal disease or LMD). The vaccine, specifically targeting HER2/HER3, is administered intrathecally (directly into the spinal fluid) via an Ommaya reservoir, aiming to boost the immune system’s ability to fight the cancer.
Read more about the trial here.
Watch the video below to hear Dr. Peter Forsyth, Chair, Neuro-Oncology at Moffitt Cancer Center, discuss the Dendritic Cell Vaccine for Metastatic Triple Negative or HER2+ Breast Cancer With Leptomeningeal Disease
NRG BN014 RADIATE-LM
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.
REMASTer: REcurrent Brain Metastases After SRS 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.
ReSPECT-LM Clinical 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.
Screening MRI of the Brain in Patients with Metastatic or Inflammatory Breast Cancer: A Prospective Study
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.
MBCBrainmets.org will be highlighting various clinical trials led by our Medical Advisory Board. We are not suggesting that this trial is the best option for you, but we hope you find it a helpful way to learn about one clinical trial. Not every clinical trial is a good match for every patient, but there are many ongoing and new clinical trials for patients living with MBC Brain Mets and Leptomeningeal Disease. To view examples of other ongoing clinical trials for Stage IV MBC Brain Mets, visit our Clinical Trials page.
