Demo Trial For Design Demo Trial For Design Demo Trial For Design Demo Trial For Design Demo Trial For Design  

This is an overview of the demo trial for design.

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SAR439859 Plus Palbociclib as First Line Therapy for Patients With ER(+) HER2(-) Advanced Breast Cancer

Primary Objective: To determine whether SAR439859 in combination with palbociclib improves progression free survival (PFS) when compared with letrozole in combination with palbociclib in participants with ER+, HER2- advanced breast cancer who have not received any prior systemic anticancer therapies for advanced disease. Secondary Objective: To compare the overall survival …

High Risk ER+HER2- T1-2N0-1 Early Breast Cancer With Palbociclib Plus Endocrine Therapy(HIPEx)

This is a phase II, multi-center, single-arm, open-label trial to evaluate efficacy of palbociclib with endocrine therapy as adjuvant treatment in women with C-high/G-high risk ER-positive/HER2-negative T1-2N0-1 EBC(Early Breast Cancer)

Ipatasertib + Pertuzumab +Trastuzumab in Advanced HER2+ PI3KCA-mutant Breast Cancer Patients

This is an open label, single arm, multicenter, phase Ib study to evaluate the safety and clinical activity of the combination of ipatasertib, trastuzumab and pertuzumab in patients with unresectable locally advanced or metastatic HER2-positive breast cancer with tumors harboring PIK3CA mutations, candidates to receive maintenance HP after first line …

Trastuzumab Combined With Pyrrolidine and Chemotherapy for Locally HER2 Positive Breast Cancer

This study is a one-arm, open, phase II clinical study, and the study subjects are locally advanced and inflammatoryPatients with sexual or early HER2-positive breast cancer entered the trial period after signing informed consentTo evaluate trastuzumab combined with pyrrolitinib and chemotherapy regimen (TCbH+Py) for HER2 positive breastPathologic complete response rate …

A Study of SBT6050 in Patients With Advanced HER2 Expressing Solid Tumors

A first-in-human (FIH) study using SBT6050 in HER2 expressing advanced malignancies

Pyrotinib Trastuzumab Pertuzumab and Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer

This study aims to evaluate the efficacy and safety of pyrotinib in combination with trastuzumab, pertuzumab and nab-paclitaxel as neoadjuvant therapy in early stage or locally advanced HER2-positive breast cancer.

HER2-PREDICT: Translational Study of Tumor Samples From DS8201-A-U301 and DS8201-A-U302 Trials.

Patients who will participate, are participating or have participated in Daichi Sankyo INC sponsored Ds8201-A-U301 and Ds8201-A-U302 trials will be asked to participate to HER2-PREDICT study offering them a new informed consent. In order to identify mRNA ERBB2 levels, we will evaluate by gene expression tumor samples from these patients.

A Study to Evaluate the Efficacy and Safety of the Combination of TQ-B211 Plus Docetaxel in Patients With HER2-positive MBC.

To evaluate the efficacy,safety and immunogenicity of TQ-B211 plus docetaxel versus Herceptin plus docetaxel in Patients with HER2-positive metastatic breast cancer.Trastuzumab plus docetaxel was chosen as the comparator in the control group,as it represents a common first-line treatment option used in HER2+ MBC population in China.