Baptist Health South Florida
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.
Inclusion Criteria: 1. Histologically confirmed HER-2-positive breast cancer with newly diagnosed brain metastases. 2. ECOG Performance Status (PS) of 0, 1, 2. 3. 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. 4. Age ≥ 18 years 5. Signed written informed consent by patient or legally authorized representative. A signed informed consent must be obtained prior to any study-specific procedures. 6. Life expectancy of at least 12 weeks…
T-DXd will be given as an IV infusion every 21 days. This Phase 1 study will use predefined dose levels (5.4 mg/kg, 4.4 mg/kg, and 3.2 mg/kg) to evaluate safety and tolerability. Participants may continue treatment until disease progression, unacceptable side effects, or withdrawal.
Participants will receive SRS to intact brain metastases. Typical dosing is 20-24 Gy in a single fraction for lesions \<20 mm, or 27 Gy in 3 fractions for lesions ≥20 mm. Exact dosing will be based on the treating radiation oncologist's clinical judgment.
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