Trastuzumab Deruxtecan + Stereotactic Radiosurgery (SRS) in HER2+ Breast Cancer Brain Metastases
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorBaptist Health South Florida
About this trial
A phase I clinical trial (a type of research study) for people with human epidermal growth factor receptor 2 (HER-2) positive breast cancer with metastasis to the brain. This research study will evaluate how well brain metastases can be controlled using a type of radiation therapy known as stereotactic radiosurgery (SRS) when combined with the therapeutic agent Trastuzumab Deruxtecan (T-DXd). The combined use of SRS with T-DXd is considered investigational.
Eligibility criteria
Qualifiers
Histologically confirmed HER-2-positive breast cancer with newly diagnosed brain metastases.
ECOG Performance Status (PS) of 0, 1, 2.
Participants with 1-10 brain metastases will be candidates for T-DXd with SRS at the discretion of the treating radiation oncologist. Intra-cranial metastasis must measure 3 cm or less in the greatest dimension.
Age ≥ 18 years
Disqualifiers
Participants with leptomeningeal metastases documented by MRI or CSF evaluation.
Evidence of intra-tumoral or peri-tumoral hemorrhage deemed clinically significant by the treating physician.
Brain metastases within 5 mm of the optic chiasm or optic nerve.
Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom, e.g., Crohn's disease, malabsorption, or CTCAE grade > 2 diarrhea of any etiology at baseline.
Trial design
Treatments tested in this trial
- Trastuzumab Deruxtecan
- Stereotactic Radiosurgery
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Baptist Health South Florida
Lead sponsor
National Brain Tumor Society
Collaborator
Source ClinicalTrials.gov