Trastuzumab Deruxtecan + SRS for HER2+ Breast Cancer Brain Metastases
This study is for women aged 18 or older with HER2-positive breast cancer that has spread to the brain. It's a Phase 1 study, meaning it's an early-stage trial focused on safety. Researchers are testing a combination of Trastuzumab Deruxtecan (T-DXd), an IV medication given every 21 days, and Stereotactic Radiosurgery (SRS), a type of radiation therapy for brain tumors. The main goal is to find the safest dose of T-DXd when given with SRS and to see what side effects might occur. You would need to have 1 to 10 brain tumors, each 3 cm or smaller. The study is planning to enroll 20 participants, but its current recruitment status is unclear.
- Study design
- This is a Phase 1 interventional study, which means all participants receive the study treatments. It plans to enroll 20 participants.
- What's involved
- You would receive Trastuzumab Deruxtecan as an IV infusion every 21 days and Stereotactic Radiosurgery for your brain metastases. Treatment may continue until disease progression or unacceptable side effects.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints, which measure safety and the maximum tolerated dose, are evaluated at 3 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Trastuzumab Deruxtecan + Stereotactic Radiosurgery (SRS) in HER2+ Breast Cancer Brain Metastases
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Manmeet Ahluwalia · PRINCIPAL_INVESTIGATOR · Miami Cancer Institute
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Incidence of dose-limiting toxicities (DLTs)3 weeks
DLTs will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 starting from the first dose of T-DXd through 3 weeks after SRS. DLT is defined as the appearance of side effects during treatment that are severe enough to prevent continuation of treatment at a participant's assigned dose. Any of the following events will be considered a DLT if treatment-related: * ≥ Grade 4 non-hematologic toxicity except nausea and vomiting (if manageable with supportive care measures), alopecia, drug-related fever, and toxicities secondary to neutropenia and sepsis * ≥ Grade 3 neurologic toxicity (sensory or autonomic) * Grade 4 platelet count (\<25,000/mm³) 50 days beyond the start of the most recent chemotherapy (not related to recurrent leukemia) * Grade 4 neutropenia 50 days beyond the start of the most recent chemotherapy (not related to recurrent leukemia) * Grade 3 non-hematologic toxicity (excluding alopecia or toxicities secondary to neutropenia
- Determination of the maximum tolerated dose (MTD) of T-DXd in combination with SRS3 weeks
The MTD will be determined using a standard 3+3 dose de-escalation design across predefined dose levels of T-DXd (5.4 mg/kg, 4.4 mg/kg, and 3.2 mg/kg IV every 21 days), based on the number of participants who experience a DLT at each dose level.