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

NCT07100600 | Recruiting Phase 2 DMC

• 1 other identifier: 2025-408-001
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• PFS

  up to 1.5 years

Secondary Outcomes (4)

• CNS-ORR

  2 months

• ORR by investigator using RECIST Guideline

  2 months

• CNS-PFS

  1.5 year

• Adverse events

  up to 1.5 years

Study Arms (2)

control group

ACTIVE COMPARATOR

Trastuzumab Rezetecan

Drug: Trastuzumab Rezetecan

experimental group

EXPERIMENTAL

Trastuzumab Rezetecan combined with radiotherapy

Drug: Trastuzumab Rezetecan; Radiation: FSRT or WBRT

Interventions

Trastuzumab Rezetecan DRUG

Trastuzumab Rezetecan：4.8mg/kg Q3W

control group; experimental group

FSRT or WBRT RADIATION

FSRT （8Gy/3-5 fx）or WBRT（30Gy/10fx）

experimental group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females ≥18 yrs old;
• Pathologically confirmed HER2-positive advanced breast cancer;
• At least one measurable intracranial lesion according to RANO-BM criteria, which had not received local treatment;
• Without prior cranial radiation and had no indication for immediate local treatment or refuse to local treatment;
• Life expectancy is not less than 6 months.
• Adequate function of major organs.

You may not qualify if:

• Subjects with leptomeningeal metastasis
• CNS complications requiring emergency neurosurgical intervention
• 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;
• Suffering from heart disease that is not well controlled or having clinical symptoms
• History of clinically significant lung disease；
• 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.
• Female subjects during pregnancy and lactation
• Any other conditions that researchers believe that patients are unsuitable for this study.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Professor

Zhengzhou, Henan, China

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: July 27, 2025
• First Posted: August 3, 2025
• Study Start: August 30, 2025
• Primary Completion (Estimated): July 30, 2030
• Study Completion (Estimated): December 30, 2032
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)