Status:
NOT_YET_RECRUITING
SHR-A1811 and THPy in First or Second Line for HER2 Positive Advanced Breast Cancer Brain Metastases
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The aim of this project is to evaluate whether the sequence of Trastuzumab，pyrotinib and Nab-Paclitaxel in first line followed by SHR-A1811 in second line is superior to the sequence of SHR-A1811 in f...
Eligibility Criteria
Inclusion
- Females ≥18 yrs old
- Pathologically confirmed HER2-positive advanced breast cancer;
- Newly diagnosed brain metastes,At least one measurable intracranial lesion
- Not received any systemic treatment for advanced stage
- Radiotherapy was allowed in patients with an urgent need for control of intracranial symptoms
- Adequate function of major organs
- Willing to join in this study, able to provide written informed consent, good compliance and willing to cooperate with follow-up.
Exclusion
- Has leptomeningeal metastasis or cystic metastatic lesions confirmed by MRI or lumbar puncture; 2.Existence of third space fluid (e.g. massive ascites, pleural effusion, pericardial effusion) that is not well controlled by effective methods, e.g. drainage; 3.Has received whole brain radiotherapy, chemotherapy, surgery within 2 weeks before first dose of study therapy; 4.Has known clinically significant lung disease, that is, moderate-to-severe lung disease which severely affects respiratory function, including but not limited to: idiopathic pulmonary fibrosis, pneumonitis. Prior ≥ grade 3 interstitial lung disease is not allowed to enrolment; 5.Has received full-dose anticoagulants or thrombolytics within 10 days before enrolment, or non-steroid anti-inflammatory drugs with platelet inhibition 6.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; 7.Participated in other drug clinical trials within 4 weeks before admission; 8.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.
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Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06975475
Start Date
June 1 2025
End Date
June 1 2028
Last Update
May 16 2025
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