Status:
NOT_YET_RECRUITING
A Phase II Study of T-DXd Plus SRT in HER2-positive Breast Cancer Brain Metastases
Lead Sponsor:
Fudan University
Conditions:
Breast Cancer
Brain Metastases
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This research study will evaluate the efficacy and safety of stereotactic radiotherapy (SRT) combined with Trastuzumab-Deruxtecan (T-DXd; DS-8201a) in HER2-positive Breast Cancer Patients with newly d...
Eligibility Criteria
Inclusion
- 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):
- Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L, Platelets≥ 90 x 109/L, Hemoglobin ≥ 90 g/L
- Aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≤2.5 x ULN without liver metastasis,≤ 5 x ULN with liver metastases
- Serum BUN and creatinine ≤ 1.5 x Upper Limit of Normal (ULN)
- LVEF ≥ 50%
- QTcF \< 480 ms
- INR≤1.5×ULN，APTT≤1.5×ULN
- Signed the informed consent form prior to patient entry
Exclusion
- Leptomeningeal or hemorrhagic metastases
- Uncontrolled epilepsy
- Severe or uncontrolled disease: severe cardiovascular disease, end-stage renal disease, severe hepatic disease, history of immunodeficiency, including HIV positive, active HBV/HCV or other acquired congenital immunodeficiency disease, or organ transplantation history, active infection, etc.
- History of allergy to treatment regimens
- Pregnancy or lactation period， women of child-bearing age who are unwilling to accept contraceptive measures.
- Inability to complete enhanced MRI
- Not suitable for inclusion for specific reasons judged by sponsor
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT06088056
Start Date
November 1 2023
End Date
July 1 2026
Last Update
October 18 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fudan University Shanghai Cancer Center
Shanghai, China