Lead Investigator: Zhi Xiao, Xiangya Hospital, Central-South University
Title of Proposal Research: Roles of neutrophil/lymphocyte ratio (NLR) and platelet/lymphocyte ratio (PLR) in prognosis and in differentiation of potential beneficiaries in HER2-positive breast cancer with trastuzumab therapy
Vivli Data Request: 6759, 5936
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
HER2 is an oncogene and is associated with aggressive tumor growth and poor prognosis. Oncogene is a kind of gene having the potential to cause a normal cell to become cancerous or to strengthen the ability of invasion and metastases of cancerous cell. HER2 is over-expressed in 20-25% of all invasive breast cancer (BC). Trastuzumab (Herceptin®) is an effective therapy for HER2 over-expression BC and can decrease the risk of relapse around 25%. Meanwhile, the situation that HER2-positive BC have no response to trastuzumab treatment exists indeed. The mechanism of trastuzumab resistance is not yet understood, and there is no factor that could predict the sensitivity to trastuzumab of HER2-positive breast cancer.
Requested Studies:
(Note: study removed as part of Data Request 6759)
A Randomized Three-Arm, Multicenter Comparison of 1 Year and 2 Years of Herceptin Versus No Herceptin in Women With HER2-Positive Primary Breast Cancer Who Have Completed Adjuvant Chemotherapy (HERA)
Sponsor: Hoffmann-La Roche
Study ID: NCT00045032
Sponsor ID: BO16348
(Note: studies added as part of Data Request 6759)
Chemotherapy and Antibody Response Evaluation (CARE): A phase III, multinational, randomized study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) combined with chemotherapy in patients with HER2 overexpression who have not received cytotoxic chemotherapy for metastatic breast cancer.
Sponsor: Roche
Study ID: H0648G
Sponsor ID: H0648G
A Multicenter, Randomized Comparative Study on the Efficacy and Safety of Herceptin (Trastuzumab) Plus Docetaxel (Taxotere) Versus Docetaxel Alone as First Line Treatment in Patients with HER2-Positive Metastatic Breast Cancer
Sponsor: Roche
Study ID: M77001
Sponsor ID: M77001
A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer
Sponsor: Roche
Study ID: NCT00567190
Sponsor ID: TOC4129g