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Clinical Trials in China / NCT07100600
Recruiting Phase 2

Trastuzumab Rezetecan Combined With Radiotherapy Versus Trastuzumab Rezetecan in the Treatment of HER2-positive Advanced Breast Cancer With Brain Metastases

NCT07100600 · tracked via the Priya Life Science China tracker
Sponsor
Henan Cancer Hospital
Phase
Phase 2
Started
2025-08-30
Last updated
2026-10-13

Condition(s) studied

HER2-positive Advanced Breast CancerBrain MetastasesRadiotherapy

Investigational drug(s) / intervention(s)

Trastuzumab Rezetecan →FSRT or WBRT

Trastuzumab Rezetecan: Trastuzumab Rezetecan：4.8mg/kg Q3W

FSRT or WBRT: FSRT （8Gy/3-5 fx）or WBRT（30Gy/10fx）

Study summary

A total of 224 subjects of HER2-positive advanced breast cancer with brain metastases are planned to be enrolled. Eligible subjects will be randomly assigned in a 1:1 ratio to the group receiving Trastuzumab Rezetecan combined with radiotherapy or the group receiving Trastuzumab Rezetecan monotherapy until disease progression, intolerable toxicity, withdrawal of informed consent, or the study determines that treatment must be terminated (whichever occurs first).

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Females ≥18 yrs old; 2. Pathologically confirmed HER2-positive advanced breast cancer; 3. At least one measurable intracranial lesion according to RANO-BM criteria, which had not received local treatment; 4. Without prior cranial radiation and had no indication for immediate local treatment or refuse to local treatment; 5. Life expectancy is not less than 6 months. 6. Adequate function of major organs. Exclusion Criteria: 1. Subjects with leptomeningeal metastasis 2. CNS complications requiring emergency neurosurgical intervention 3. Previous treatment with trastuzumab deruxtecan (DS-8201a) or any other antibody drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase 1 inhibitor; 4. Suffering from heart disease that is not well controlled or having clinical symptoms 5. History of clinically significant lung disease； 6. Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years. 7. Female subjects during pregnancy and lactation 8. Any other conditions that researchers believe that patients are unsuitable for this study.

Primary outcome measure(s)

  • PFS — up to 1.5 years

Trial sites (1)

FacilityCityRegionStatus
Professor Zhengzhou Henan Recruiting

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Other trials for the same condition

Short-Course Radiotherapy Followed by CAPOX With or Without Iparomlimab and Tuvonralimab in pMMR/MSS Locally Advanced Rectal Cancer Recruiting
Real-world Study on the Efficacy, Safety, and Prognostic Factors of Immune Checkpoint Inhibitors Combined With Radiotherapy in Patients With Malignant Tumors: A Prospective Non-interventional Clinical Study Starting soon
Cranial Radiotherapy Plus Chemoimmunotherapy in Untreated Driver-mutation Negative NSCLC With Stable Brain Metastasis Recruiting
Safety, Efficacy, and Survival Outcomes of Neoadjuvant/Induction Immunotherapy in Surgical and Radiotherapeutic Management of Non-Small Cell Lung Cancer Recruiting
Node-Sparing Short-Course Radiotherapy Plus First-Line Therapy and PD-1 Inhibitor in Unresectable/Metastastic pMMR/MSS Gastric Cancer (MODIFI-GC) Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07100600 on ClinicalTrials.gov ↗ ← All trials in China