NCT05769010 Study of SHR-A1811 in HER2-expression Advanced Breast Cancer With Brain Metastases
| NCT ID | NCT05769010 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Henan Cancer Hospital |
| Condition | Metastatic Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-03-31 |
| Primary Completion | 2028-12-30 |
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 150 participants in total. It began in 2023-03-31 with a primary completion date of 2028-12-30.
⚠ 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
This study aimed to evaluate the use of SHR-A1811 in HER2-expression Advanced Breast Cancer patients with brain metastases.
Eligibility Criteria
Inclusion Criteria: 1. Females and males ≥18 yrs old; 2. Pathologically confirmed HER2-positive or HER2-low 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. More than 2 weeks from last systemic treatment; patients with new brain lesions after craniocerebral surgery were admitted if no radiotherapy was performed. Patients with HER2-Low disease must not have systemic treatment for brain metastases. 6. Prior HER2-target treatment, endocrine therapy and chemotherapy was allowed; 7. Life expectancy is not less than 6 months. 8. Adequate function of major organs. Exclusion Criteria: 1. Leptomeningeal involvement; 2. CNS complications requiring emergency neurosurgical intervention (e.g. excision, shunt tube placement);or uncontrolled symptomatic brain metastases; 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. Patients who had progressed on previous HER2 tyrosine kinase inhibitor therapy were excluded from Arm 2, and those who had progressed on previous bevacizumab therapy were excluded from Arm 3 and Arm 5 ,and Arm 6 excludes patients who have progressed on prior PD-1 or PD-L1 therapy; 5. No concurrent antitumor therapy for metastatic cancer other than the study treatment; 6. Antitumor radiotherapy, chemotherapy, surgery, targeted therapy, or immunotherapy within 2 weeks or endocrine therapy within 1 week prior to enrolment; 7. Participated in other drug clinical trials within 4 weeks before admission; 8. History of clinically significant lung disease； 9. 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. 10. According to the judgement of the researchers, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of research (including, but not limited to, severe hypertension, severe diabetes, active infections, etc.). 11. Any other conditions that researchers believe that patients are unsuitable for this study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05769010 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Metastatic 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 NCT05769010 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 NCT05769010 currently recruiting?
Yes, NCT05769010 is actively recruiting participants. Contact the research team at ym200678@126.com for enrollment information.
Where is the NCT05769010 trial being conducted?
This trial is being conducted at Zhengzhou, China.
Who is sponsoring the NCT05769010 clinical trial?
NCT05769010 is sponsored by Henan Cancer Hospital. The trial plans to enroll 150 participants.
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