Clinical breast cancer
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Clinical breast cancer · Oct 2002
ReviewHER2-positive breast cancer: update on Breast Cancer International Research Group trials.
HER2 gene amplification occurs in approximately 20% of primary breast cancers and is associated with a poor prognosis. Recently, trastuzumab, a humanized murine monoclonal antibody directed against the extracellular domain of HER2, was introduced for the treatment of patients with HER2-overexpressing advanced breast cancer. Trastuzumab has activity as both a single agent and in combination with chemotherapy. ⋯ BCIRG 007 compares TH and TCH as first-line therapy in patients with HER2-positive metastatic breast cancer. In both trials, entry is restricted to patients whose tumors are positive for HER2 gene amplification as determined by fluorescence in situ hybridization. The data from these trials, in addition to the results from other ongoing randomized studies, will help define the optimal way to utilize trastuzumab in the management of patients with HER2-positive breast cancer.
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Clinical breast cancer · Jun 2002
Randomized Controlled Trial Comparative Study Clinical TrialThe study of tamoxifen and raloxifene: preliminary enrollment data from a randomized breast cancer risk reduction trial.
Tamoxifen reduced the risk of invasive breast cancer by 49% among women at increased risk for breast cancer in the Breast Cancer Prevention Trial P-1, and raloxifene reduced breast cancer incidence by more than 70% in the Multiple Outcomes of Raloxifene Evaluation osteoporosis trial. These findings led the National Surgical Adjuvant Breast and Bowel Project to design and launch the Study of Tamoxifen and Raloxifene. Risk-eligible women are = 35 years of age and postmenopausal; they have either lobular carcinoma in situ (LCIS) or a 5-year risk of invasive breast cancer of at least 1.67% as determined by the Gail model. ⋯ LCIS was reported in 8.4% of women prior to randomization. Gail model risk was = 3.0% in 5 years for 59.3% of white women, 45.0% of black women, and 44.5% of Hispanic women. The trial will recruit a total of 22,000 postmenopausal women and is powered to demonstrate superior efficacy of either agent or their equivalence in reducing the incidence of primary breast
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Clinical breast cancer · May 2002
ReviewPreclinical studies of gemcitabine and trastuzumab in breast and lung cancer cell lines.
Overexpression of the HER2/neu oncogene and receptor protein has been reported in 20%-30% of patients with breast cancer and is associated with a poor prognosis. HER2/neu expression in breast cancer patients assessed by fluorescence in situ hybridization or immunohistochemistry is a predictor for response to trastuzumab, a humanized monoclonal antibody against the HER2/neu cell-surface protein. Data regarding HER2/neu expression in lung cancer are more limited, and there is little information regarding HER2/neu expression and response to trastuzumab alone or in combination with chemotherapeutic agents. ⋯ The degree of synergy observed did not directly correlate with the level of surface protein expression, as synergy was seen even in cancer cell lines expressing low levels of HER2/neu. No treatment effect was seen in the SCLC cell line, which did not express HER2/neu. These preclinical studies indicate a need to study the clinical synergistic effects of the gemcitabine/trastuzumab combination in breast cancer and NSCLC patients whose tumors overexpress HER2/ neu.
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Clinical breast cancer · Oct 2001
ReviewCombining the anti-HER2 antibody trastuzumab with taxanes in breast cancer: results and trial considerations.
Overexpression of the p185/HER2 protein is seen in 20%-25% of primary breast cancers and is associated with poor prognosis. Recent phase II and III clinical trials demonstrate that trastuzumab is active against breast tumors, both as a single agent and in combination with chemotherapy. In patients with HER2-overexpressing metastatic breast cancer, use of trastuzumab in combination with chemotherapy is associated with a 20% reduction in relative risk of death and an increase in median survival from 20.3 to 25.1 months compared to chemotherapy alone. ⋯ Preliminary data from 3 phase II studies suggest a 44%-63% response rate when the combination is used first or second line in HER2-overexpressing metastatic breast cancer. The combination of docetaxel with trastuzumab is well tolerated and has not been associated with significant cardiotoxicity. Given in vitro evidence that platinum salts act synergistically with trastuzumab and docetaxel, and phase II data suggesting clinical efficacy and good tolerability, the combination of platinum salt plus trastuzumab and docetaxel is now being assessed in adjuvant trials