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的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 本研究的主要目的是：1）评估西妥昔单抗单药治疗三阴性乳腺癌的总体缓解率，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体缓解率。 该研究将招募约100名患有雌激素受体（ER）和孕激素受体（PR）以及HER-2阴性转移性乳腺癌的女性，其中93名将被随机分配。妇女将在两年内在几个合作中心注册。受试者可能接受过不超过3种既往辅助或转移性疾病化疗方案，但既往未接受过转移性疾病含铂方案或EGFR抑制剂治疗。 参与者最初将随机接受每周一次西妥昔单抗或每周一次西妥昔单抗加卡铂（四周中的三周）。将每8周对他们进行一次再分级，以评价可测量的疾病，并根据RECIST标准定义肿瘤缓解。在第1组发生进展后，这些受试者将继续接受西妥昔单抗治疗，但将在方案中添加卡铂。对于可触及肿瘤的受试者，将在每周一次西妥昔单抗治疗后和联合治疗一周后进行活检。

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.