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
ELECTRA: An Open-label Multicenter Phase 1b-2 Study of Elacestrant in Combination with Abemaciclib in Women and Men with Brain Metastasis from Estrogen Receptor Positive, HER-2 Negative Breast Cancer
This is a multi-site, global, open-label study that includes a phase 1b evaluation of elacestrant in combination with abemaciclib in women and men with brain metastases from estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER-2) negative breast cancer. Phase 1b was designed to select the recommended phase 2 dose and is followed by an ongoing phase 2 evaluation of elacestrant in combination with abemaciclib in patients with active brain metastases from ER-positive, HER-2 negative breast cancer.
Read more about the trial here.
Watch the video below to hear Dr. Nancy Lin, Medical Oncologist, Dana-Farber Cancer Institute, discuss the trial.
More information can also be found on the Dana Farber website.
This program is supported by funding from Menarini Stemline. Content is developed independently by SHARE Cancer Support.
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.
Phase 2 Single Arm Trial with a Safety Lead-in of Tucatinib in Combination with Doxil for the Treatment of HER2+ Metastatic Breast Cancer
This clinical trial is evaluating an oral HER2-specific kinase inhibitor combined with a chemotherapeutic agent (Doxil) in patients with HER2+ metastatic breast cancer (MBC). This trial is a great option for patients who can benefit from anthracycline (Doxil) + anti-HER2 therapy without having to receive trastuzumab and thus avoiding potential cardiac toxicities. Moreover, since it is a single arm trial, all patients on the trial will get the study treatment. The study permits patients who have received multiple prior therapies as well as patients with and without active brain metastases.
This trial is open at multiple locations in the US.
Read more about the trial here.
Watch the video below to hear Dr. Erika Hamilton, Oncologist at the Sarah Cannon Research Institute Practices at SCRI Oncology Partners, discuss the 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 the University of Colorado School of Medicine, 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.
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.
