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

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

NCT ID: NCT06088056

Condition: Breast Cancer
Brain Metastases
Radiotherapy

Conditions: Official terms:
Breast Neoplasms
Neoplasm Metastasis
Brain Neoplasms

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Combination use of SRT with T-DXd
Description: Radiation therapy SRT will be implemented according to investigator's clinical practice(based on brain metastases number and tumor volume). T-DXd(5.4mg/kg, once per 21 days, initiated within 2 weeks after SRT) will be provided to patients with confirmed HER2 positive breast cancer and brain metastasis until tumor progression, a severe adverse event deemed related to the study drug, or death. All dose adjustments should be based on the most severe toxicity level (CTCAE version 5.0) that occurred. Two doses are allowed to be reduced. Dose Level 0: 5.4mg/kg Dose Level 1 :4.4mg/kg Dose Level 2: 3.2mg/kg
Arm group label: Combination use of SRT with T-DXd

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 diagnosed or progressing Brain Metastases.

Criteria for 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 entry Exclusion Criteria: - 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

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Fudan University Shanghai Cancer Center

Address:
City: Shanghai
Country: China

Contact:
Last name: Zhaozhi yang, PhD

Phone: +8618017317126
Email: yzzhi2014@163.com

Contact backup:
Last name: Jin Meng, PhD

Phone: +8618121299532
Email: jinmeng@fudan.edu.cn

Investigator:
Last name: Zhaozhi Yang, PhD
Email: Principal Investigator

Start date: November 2023

Completion date: July 2026

Lead sponsor:
Agency: Fudan University
Agency class: Other

Source: Fudan University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06088056