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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	Female

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06088056
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Fudan University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Zhaozhi YangJiayi Chen
Principal Investigator Affiliation	Fudan UniversityRuijin Hospital affiliated to Shanghai Jiaotong University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Breast Cancer, Brain Metastases, Radiotherapy

Arms & Interventions

Arms

Experimental: Combination use of SRT with T-DXd

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

Interventions

Drug: - Combination use of SRT with T-DXd

Contact a Trial Team

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International Sites

Fudan University Shanghai Cancer Center, Shanghai, China

Status

Address

Fudan University Shanghai Cancer Center

Shanghai, ,

Site Contact

Zhaozhi yang, PhD

yzzhi2014@163.com

+8618017317126

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