R&D
Clinical Recruitment
Biostar is currently conducting several clinical trials, which are open recruiting.
Note: The above recruitment information only lists the main inclusion criteria for the trial. If you meet the above main inclusion criteria and wish to participate in the trial, with your written consent, you will be required to take a medical history inquiry, physical examination, laboratory examination, imaging evaluation (CT/MRI), etc., which will be paid by our company. If, after assessment, you meet all relevant criteria in the study protocol, you may participate in the study.
If you want to enroll in the clinical trial, you have the right to consult the relevant information during the medication period and the right to withdraw from this study at any time, and your privacy will be protected.
A Pivotal Phase II Clinical Trial of Utidelone Injection (UTD1) Plus Capecitabine (CAP) in HER2-negative Breast Cancer Patients with Brain Metastases
Clinical trial information
Our company is currently conducting a clinical trial to evaluate the tolerability of utidelone injection (UTD1) plus capecitabine (CAP) in HER2-negative breast cancer patients with brain metastases. This study is a multicenter, two-stage clinical study. A total of 120 participants with HER2-negative breast cancer with brain metastases will be enrolled. The primary objective of this study is to evaluate the intracranial objective response rate (IC-ORR). The secondary objective includes: to evaluate the IC-ORR, ORR, progression free survival (PFS), disease control rate (DCR), duration of response (DOR), IC-PFS, IC-DCR, IC-DOR, overall survival (OS), safety, and pharmacokinetic characteristics.
Main inclusion criterion
· Male or female aged ≥18 years
· Have histologically confirmed HER2-negative metastatic breast cancer. HER2-negative defined as immunohistochemical (IHC) score of 0 or 1+, or IHC2+ with negative HER2 expression on in situ hybridization (ISH)
· Based on screening contrast-enhanced brain MRI, patients must have at least one measurable intracranial lesion according to RECIST 1.1 (≥1.0 cm in size) and must have one of the following:
Untreated brain metastases not needing immediate local therapy.
Brain metastases progressing after prior local therapy
· ≤ 3 prior lines of chemotherapy in advanced or metastatic setting.