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

NCT ID: NCT07100600

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-30
• Study Completion Date: 2032-12-30

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).

Conditions

HER2-positive Advanced Breast Cancer; Brain Metastases; Radiotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

control group

Trastuzumab Rezetecan

Group Type: ACTIVE_COMPARATOR

Trastuzumab Rezetecan

Intervention Type: DRUG

Trastuzumab Rezetecan：4.8mg/kg Q3W

experimental group

Trastuzumab Rezetecan combined with radiotherapy

Group Type: EXPERIMENTAL

Trastuzumab Rezetecan

Intervention Type: DRUG

Trastuzumab Rezetecan：4.8mg/kg Q3W

FSRT or WBRT

Intervention Type: RADIATION

FSRT （8Gy/3-5 fx）or WBRT（30Gy/10fx）

Interventions

Trastuzumab Rezetecan

Trastuzumab Rezetecan：4.8mg/kg Q3W

Intervention Type: DRUG

FSRT or WBRT

FSRT （8Gy/3-5 fx）or WBRT（30Gy/10fx）

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Min Yan, MD

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Professor

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Min Yan professor

Role: primary

ym200678@126.com

+86 15713857388

Other Identifiers

2025-408-001

Identifier Type: -

Identifier Source: org_study_id