A Phase II Study of T-DXd Plus SRT in HER2-positive Breast Cancer Brain Metastases

No open prediction endpoints

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Key Facts

Primary Endpoints (CT.gov)

Secondary Endpoints

Eligibility Criteria

Inclusion Criteria: * Pathologically confirmed HER2 positive advanced breast cancer * Age\>18 years. * Brain metastases confirmed by enhanced brain MRI. Metastases number less than 15. * KPS≥70 or KPS ≥60 with neurologic symptoms caused by BM * Life expectancy of more than 6 months * Prior therapy of oral dexamethasone not exceeding 16mg/d * Time interval from prior therapy was more than 2 weeks, and evaluation of adverse events is no more than grade 1. * Screening laboratory values must meet the following criteria( and should be obtained within 28 days prior to registration): 1. Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L, Platelets≥ 90 x 109/L, Hemoglobin ≥ 90 g/L 2. Aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≤2.5 x ULN without liver metastasis,≤ 5 x ULN with liver metastases 3. Serum BUN and creatinine ≤ 1.5 x Upper Limit of Normal (ULN) 4. LVEF ≥ 50% 5. QTcF \< 480 ms 6. INR≤1.5×ULN，APTT≤1.5×ULN * Signed the informed consent form prior to patient …

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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