Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07100600

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

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

HER2-positive Advanced Breast Cancer Brain Diseases Brain Metastases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Radiotherapy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Trastuzumab Rezetecan

Drug

Trastuzumab Rezetecan：4.8mg/kg Q3W

FSRT or WBRT

Radiation

FSRT （8Gy/3-5 fx）or WBRT（30Gy/10fx）

Primary outcomes

  1. PFS

    Time frame: up to 1.5 years

Secondary outcomes

  1. CNS-ORR

    Time frame: 2 months

  2. ORR by investigator using RECIST Guideline

    Time frame: 2 months

  3. CNS-PFS

    Time frame: 1.5 year

  4. Adverse events

    Time frame: up to 1.5 years

Sponsors and collaborators

Lead sponsor

Henan Cancer Hospital

Other Gov

Registry information

Official study title

An Open-label, Randomized, Controlled Trial of Trastuzumab Rezetecan Combined With Radiotherapy Versus Trastuzumab Rezetecan in the Treatment of HER2-positive Advanced Breast Cancer With Brain Metastases

Important dates

Study start
2025
Primary completion
2030
Study completion
2032
First posted
Aug 3, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.