STUDY OF STANDARD DOXORUBICIN AND CYCLOPHOSPHAMIDE IN ADVANCED BREAST CANCER

标准阿霉素和环磷酰胺治疗晚期乳腺癌的研究

• 批准号: 7376307
• 负责人: Jill Gilbert
• 金额: $ 0.84万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376307
• 关键词: STUDY; STANDARD; DOXORUBICIN; CYCLOPHOSPHAMIDE; ADVANCED

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. 1. To compare the microscopic pathologic response rates in patients with inflammatory and estrogen-receptor negative locally advanced breast cancer treated with weekly doxorubicin and daily oral cyclophosphamide given with G-CSF support to that in patients treated with teh "standard" doxorubicin and cyclophosphamide regimen given every three weeks. 2. To compare the toxicities of these two regiments. 3. To compare the delivered dose intensity of these two regimens. 4. To assess the association between microscopic pathologic complete response and clinical complete response at the primary tumor site in these patients. 5. To estimate the incidence of early genetic damage during the course of treatment using two general clonal assays: a) the HUMARA (human androgen receptor assay) to screen for the presence of clonal hematopoiesis, and b) microsatellite instability (MSI) assays to screen for the presence of defective DNA mismatch repair mechanisms and loss of heterozygosity, in pretreatment blood and three sequential post-treatment specimens in breat cancer patients enrolled in this study. 6. To estimate the incidence of MLL (myelooid lymphoid leukemia) gene fusion transcripts and the frequency of RAS gene mutations (H-, K-, and N-RAS) in cases where either the HUMARA or microsatellite repeat assays are positive for clonal hematopoiesis.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。1.比较接受每周一次阿霉素和每日一次口服环磷酰胺联合G-CSF支持治疗的炎性和雌激素受体阴性局部晚期乳腺癌患者与接受“标准”阿霉素和环磷酰胺方案每3周一次治疗的患者的显微镜病理学缓解率。2.比较两种药物的毒性。3.比较这两种方案的递送剂量强度。4.评估这些患者原发肿瘤部位显微镜下病理学完全缓解与临床完全缓解之间的相关性。5.使用两种通用克隆试验估计治疗过程中早期遗传损伤的发生率：（a）人道主义法（人雄激素受体测定）以筛选克隆造血的存在，和B）微卫星不稳定性（MSI）测定以筛选缺陷性DNA错配修复机制和杂合性缺失的存在，在本研究中登记的乳腺癌患者的治疗前血液和三个连续的治疗后样本中。 6.在HUMARA或微卫星重复序列检测为克隆性造血阳性的病例中，估计MLL（髓样淋巴细胞白血病）基因融合转录本的发生率和RAS基因突变（H-、K-和N-RAS）的频率。