CHEMOTHERAPY WITH DOXORUBICIN AND DOCETAXEL IN OPERABLE STAGE I BREAST CANCER

我们对多西他赛（泰索帝）和阿霉素（阿霉素）两种药物的新组合在乳腺癌患者中的有效性印象深刻。 这种组合，我们称之为DD，已经在晚期癌症妇女中进行了测试，它似乎对肿瘤缩小非常有效。DD已经在癌症扩散到乳房和腋下淋巴结以外的妇女中进行了测试。鉴于其在更晚期癌症中的有效性，我们希望证明它将在90%以上的时间内缩小局部乳腺肿瘤，并将导致更简单的外科手术，更高的乳房保留率和更好的整体结果。除了测试DD化疗的有效性外，这项试验还将评估使用一种简单的测试（称为红霉素呼气试验（ERMBT））预测患者对化疗的耐受性的有用性。 在未来，这项测试可能使我们能够根据个体患者的新陈代谢量身定制化疗剂量。总之，这项研究试验检查了局部乳腺癌妇女手术前使用DD化疗的情况。通过这项临床试验，我们将确定对DD有良好反应的女性人数，可以保留乳房而不是乳房切除术的女性人数（如果这是她想要的），我们将检查DD化疗对肿瘤本身的影响。我们希望通过这种方式了解更有效的化疗组合，我们将能够提高治愈乳腺癌的机会。本试验将纳入经芯针活检诊断为原发性乳腺肿瘤大于1 cm但肿瘤尚未完全切除的健康女性。 这项试验的候选人可能没有接受过任何其他乳腺癌治疗，包括手术，放疗，化疗或他莫昔芬。 受试者不得妊娠或哺乳，如果其处于育龄期，则必须同意在研究期间采取有效的避孕措施。

We are very impressed with the effectiveness of a new combination of two drugs, docetaxel (Taxotere), and doxorubicin (Adriamycin) when they are used in breast cancer patients. This combination, which we call DD, has been tested in women with advanced cancer, and it appears to be very effective in causing shrinkage of tumors. DD has been tested in women whose cancer has spread beyond the breast and underarm lymph nodes. Given its effectiveness in more advanced cancer, we hope to show that it will shrink localized breast tumors over 90% of the time, and will lead to simpler surgical procedures, a higher rate of breast preservation, and a better outcome overall. In addition to testing the effectiveness of DD chemotherapy, this trial will evaluate the usefulness of using a simple test, known as the erythromycin breath test (ERMBT), in predicting how patients will tolerate the chemotherapy. In the future, this test may allow us to tailor the dose of chemotherapy to an individual patient's metabolism. In summary, this research trial examines the use of DD chemotherapy prior to surgery in women with localized breast cancer. With this clinical trial, we will determine the number of women who have an excellent response to DD, the number of women who can have breast preservation rather than mastectomy (if that is what she desires), and we will examine the effect that the DD chemotherapy has on the tumor itself. We hope that by learning about more effective chemotherapy combinations in this way, we will be able to improve the chances for cure of breast cancer. This trial will include healthy women with primary breast tumors greater than 1 cm that have been diagnosed by core needle biopsy, but whose tumors have not been completely removed yet. Candidates for this trial may not have received any other breast cancer treatments, including surgery, radiation, chemotherapy, or tamoxifen. The candidate may not be pregnant or breast feeding, and must agree to practice effective birth control during the study if she is of childbearing age.