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
neoTOV - BO45853
Brief Summary
The purpose of this study is to characterize the safety and efficacy of neoadjuvant treatment combinations with the PI3K inhibitor inavolisib. Initially, inavolisib will be combined with endocrine-based therapies in patients with untreated, PIK3CA-mutated, Stage IIIII, estrogen receptor (ER)-positive, HER2-negative breast cancer (BC) with measurable primary tumor size 1.5 cm in the longest diameter by ultrasound or magnetic resonance imaging (MRI)
Study Title
A Phase II, Open-Label, Multicenter Study Evaluating The Safety And Efficacy Of Neoadjuvant Treatment With Inavolisib Combinations In Patients With Untreated, Early-Stage, PIK3CA-Mutated Breast Cancer
Conditions
Stage II-III Breast Cancer.
SERAFA-1
Brief Summary
This is a global, multi-center, Phase IIIb interventional, prospective single-arm study which will assess the efficacy, safety, and tolerability of camizestrant in combination with ribociclib in patients with ER+ HER2- BC who have not received any other systemic treatment for advanced disease.
Study Title
SERAFA-1: A Single arm, Open label, Multicentre, Phase IIIb Study Of Camizestrant plus Ribociclib in 1 st line Treatment of ER-positive, HER2-negative Advanced Breast Cancer Patients
Conditions
Stage IV Breast Cancer