NCT07100600 Trastuzumab Rezetecan Combined With Radiotherapy Versus Trastuzumab Rezetecan in the Treatment of HER2-positive Advanced Breast Cancer With Brain Metastases
| NCT ID | NCT07100600 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Henan Cancer Hospital |
| Condition | HER2-positive Advanced Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 224 participants |
| Start Date | 2025-08-30 |
| Primary Completion | 2030-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 224 participants in total. It began in 2025-08-30 with a primary completion date of 2030-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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.
Frequently Asked Questions
Who can join the NCT07100600 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying HER2-positive Advanced Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07100600 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07100600 currently recruiting?
Yes, NCT07100600 is actively recruiting participants. Visit ClinicalTrials.gov or contact Henan Cancer Hospital to inquire about joining.
Where is the NCT07100600 trial being conducted?
This trial is being conducted at Zhengzhou, China.
Who is sponsoring the NCT07100600 clinical trial?
NCT07100600 is sponsored by Henan Cancer Hospital. The trial plans to enroll 224 participants.
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