NCT07100600RecruitingPhase 2
Trastuzumab Rezetecan Combined With Radiotherapy Versus Trastuzumab Rezetecan in the Treatment of HER2-positive Advanced Breast Cancer With Brain Metastases
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
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 224 (estimated)
- First submitted
- 27 Jul 2025
- Start date
- 30 Aug 2025
- Primary completion date
- 30 Jul 2030
- Lead sponsor
- Henan Cancer Hospital
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07100600
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 224
- From 30 Aug 2025 to the primary completion date, 30 Jul 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- 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.
- Any other conditions that researchers believe that patients are unsuitable for this study.
Other
- Subjects with leptomeningeal metastasis
- CNS complications requiring emergency neurosurgical intervention
- Female subjects during pregnancy and lactation
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Professor Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.