UAB 0543 - PHASE 2 TRIAL OF C225 -/+ CARBOPLATIN IN TRIPLE NEGATIVE METASTATIC

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项研究的主要目的是：1)评估西妥昔单抗在三阴性乳腺癌中的总有效率；2)评估西妥昔单抗联合卡铂治疗三阴性转移性乳腺癌的总有效率。 这项研究将招募大约100名患有雌激素受体(ER)和孕激素受体(PR)且HER-2阴性的转移性乳腺癌的女性，其中93人将被随机分配。女性将在两年内被几个合作中心录取。参与者可能之前接受过不超过三种辅助或转移性疾病的化疗方案，但之前没有接受过含有铂的转移性疾病方案或具有治疗意图的EGFR抑制剂。 参与者最初将随机接受每周一次的西妥昔单抗或每周一次的西妥昔单抗加卡铂(四周中的三周)。他们将每8周重新进行一次可测量疾病的评估，并根据RECIST标准定义肿瘤反应。在第1组进展后，这些参与者将继续服用西妥昔单抗，但卡铂将被添加到方案中。对于可接受肿瘤治疗的参与者，西妥昔单抗治疗一周后和联合治疗一周后将进行活组织检查。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The primary objectives of this study are to: 1) assess overall response rate to single agent cetuximab in triple negative breast cancer and 2) assess overall response rate to combination cetuximab plus carboplatin in triple negative metastatic breast cancers. The study will enroll about 100 women with estrogen receptor (ER) and progesterone receptor (PR) and HER-2 negative metastatic breast cancer to get 93 that will be randomized. Women will be enrolled at several collaborating centers over a two-year period. Participants may have received no more than three prior chemotherapy regimens for adjuvant or metastatic disease, but no prior platinum-containing regimens for metastatic disease or EGFR inhibitors with therapeutic intent. Participants will initially be randomized to receive weekly Cetuximab or weekly cetuximab plus carboplatin (three of four weeks). They will be restaged for evaluation of measurable disease every 8 weeks, and tumor response defined by RECIST criteria. Upon progression on Arm 1, those participants will remain on cetuximab but carboplatin will be added to the regimen. For participants with accessible tumor, biopsies will be performed after one weekly of cetuximab and after one week of combination therapy.