MEN1611 Dose Increase Trial for Breast Cancer Treatment: The results were encouraging.

Menarini Ricerche, the research and development arm of the Menarini Group, today announced the results of its B-PRECISE-01 clinical trial (NCT03767335), which is evaluating the effectiveness and safety of MEN1611, an effective selective phosphatidyl inositol 3-kinase (PI3K) inhibitor.
B-PRECISE-01 is an open-label, multi-center, dose incremental and extended IB phase study for HER2-positive, PIK3CA mutations, advanced or metastasis breast cancer patients.
the main purpose of this study was to determine the safety of MEN1611 and the dose of Phase II clinical trials (RP2D) when used in concerto-bead monoantigens/-fluoravis groups.
secondary objectives include initial clinical activity, pharmacodynamics and pharmacodynamics.
results show that the combination of MEN1611 plus curcture bead monoantigens and/-fluoravis groups has shown acceptable tolerance and that there is no dose-limiting toxicity during the dose phase of gradual increase, and that most treatment-related emergencies are reversible and can be controlled by supporting therapy.
RP2D is set to 48 mg BID.
men1611 combination therapy has significant anti-tumor activity in patients with advanced or metastasis breast cancer.
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