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Breast: Metastatic Clinical Trials

Showing 31-37 of 37 items
  • Evaluation of Biomarkers Associated With Response to Subsequent Therapies in Subjects With HER2-Positive Metastatic Breast Cancer
  • This is a multicenter, open-label, Phase II study in subjects with Human epidermal growth factor receptor (HER2)-positive metastatic breast cancer who received at least 2 prior lines of anti-HER2-targeted therapies of which at least one included a Trastuzumab-containing regimen. This study is a post-approval commitment with regulatory authorities. It is designed with the primary endpoint to evaluate the changes in biomarkers associated with HER family, immunomodulation, apoptosis, and Adenosine triphosphate binding cassette (ABC) transporters between the pre-treatment and disease progression biopsy. It is hypothesized that these changes in biomarkers may modulate resistance mechanisms and thereby alters the response to subsequent chemotherapy based regimens. Therefore, in addition to the description of the clinical outcome of Overall response rate, Clinical benefit rate, Progression-free survival and Overall survival for each arm, Progression-free survival on next-line therapies will be collected and summarized for each arm. All subjects will receive study treatment until disease progression, unacceptable toxicity, or subject withdrawal, and after which, will be followed for subsequent anticancer therapy and disease progression events, and survival. The primary endpoint of the study will be to evaluate changes in expression of biomarkers associated with the HER family or receptors and ligands, immunomodulation, apoptosis, and ABC transports between a pre-treatment biopsy and the disease progression biopsy. This study will evaluate potential mechanisms to explore the antitumor activity of dual blockade and will provide a descriptive clinical outcome for subjects treated with Trastuzumab in combination with Lapatinib or chemotherapy. No formal comparisons between treatment arms will be undertaken.
  • Diagnoses: Breast: Metastatic
  • Status: Recruiting
Showing 31-37 of 37 items
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