Biostar BG01-2402
Brief Summary
This study is a multicenter, two-stage clinical trial to evaluate the efficacy and safety of utidelone in combination with capecitabine in patients with HER2-negative breast cancer with brain metastases. Patients will be enrolled to receive treatment of utidelone alone or in combination with capecitabine.
The objectives both in stage I and stage II are to evaluate the intracranial and systemic efficacy and safety of utdelone plus capecitabine for the treatment of HER2-negative breast cancer patients with brain metastases.
Official Title
A Pivotal Phase II Clinical Trial of Utidelone Injection (UTD1) Plus Capecitabine (CAP) in HER2‑negative Breast Cancer Patients With Brain Metastases (NCT06764940)
Conditions
HER2-negative Breast Cancer Patients with Brain Metastases
INAVO123 Breast Cancer Study
Brief Summary
This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer (ABC).
Official Title
A Phase III, Multicenter, Randomized, Double‑Blind, Placebo‑Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor and Letrozole in Patients With Endocrine‑Sensitive PIK3CA‑Mutated, Hormone Receptor‑Positive, HER2‑Negative Advanced Breast Cancer (NCT06790693)
Conditions
Breast Cancer
