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

Not Applicable

Recruiting

• Conditions: HER2-positive Advanced Breast Cancer; Brain Metastases; Radiotherapy
• Interventions: Drug: Trastuzumab Rezetecan; Radiation: FSRT or WBRT

• Registration Number: NCT07100600
• Lead Sponsor: Henan Cancer Hospital

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-27
• Study First Submitted QC: 2025-07-27
• Status Verified: 2025-08
• Study First Posted: 2025-08-03
• Last Update Submitted: 2025-08-06
• Last Update Posted: 2025-08-11
• Study Start: 2025-08-30
• Primary Completion: 2030-07-30
• Study Completion: 2032-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 224

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Trastuzumab Rezetecan	Trastuzumab Rezetecan
experimental group	Trastuzumab Rezetecan	Trastuzumab Rezetecan combined with radiotherapy
experimental group	FSRT or WBRT	Trastuzumab Rezetecan combined with radiotherapy

Primary Outcome Measures

Name	Time	Method
PFS	up to 1.5 years

Secondary Outcome Measures

Name	Time	Method
CNS-ORR	2 months
ORR by investigator using RECIST Guideline	2 months
CNS-PFS	1.5 year
Adverse events	up to 1.5 years

Trial Locations

Locations (1)

Professor; 🇨🇳 Zhengzhou, Henan, China