NSABP B-38

NSABP B-38

• 批准号: 7607627
• 负责人: Scott Henry Kurtzman
• 金额: $ 0.16万
• 依托单位: UNIVERSITY OF CONNECTICUT SCH OF MED/DNT
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7607627
• 关键词: Adjuvant; Axillary lymph node group; Breast; Breast Carcinoma; Cancer Patient; Chemotherapy-Oncologic Procedure; Chest wall structure; Computer Retrieval of Information on Scientific Projects Database; Coupled; Dose; Enrollment; Funding; Gemcitabine/Paclitaxel; Grant; Histologic; Hormone Receptor; Institution; Invasive; National Surgical Adjuvant Breast and Bowel Project; Nodal; Numbers; Oncologist; Operative Surgical Procedures; Outcome; Paclitaxel; Patients; Pharmaceutical Preparations; Phase II Clinical Trials; Positive Lymph Node; Radiation therapy; Randomized; Rate; Recurrence; Relative (related person); Reporting; Research; Research Design; Research Personnel; Resources; Schedule; Source; Stratification; Stratification Factors; Systemic disease; Time; Toxic effect; Treatment Protocols; Treatment outcome; United States National Institutes of Health; Upper arm; Woman; base; breast lumpectomy; chemotherapy; cyclophosphamide/doxorubicin protocol; experience; gemcitabine; hormone therapy; improved; irradiation; malignant breast neoplasm; progesterone 11-hemisuccinate-(2-iodohistamine); programs; response; tumor

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. Recently, oncologists have begun treating breast cancer patients with dose dense (DD) regimens. This means that the patients receive the chemotherapy drugs over a much shorter period of time. Surprisingly, the overall toxicities experienced by the patients is no worse and the efficacy equal if not superior. Studies have shown that women with breast cancer treated with Docetaexel/Doxorubicin/Cyclophosphamide (TAC) (Arm I) or ddose-dense. Doxorubicin/Cyclophosphamide followed by DD Paclitaxel (DD AC-P) (Arm II) have improved treatment outcome compared to previously used chemotherapy regimens. Unfortunately some women still develop local, regional, and systemic disease recurrence. This reality provides a compelling reason to continue efforts to further improve therapy for node-positive breast cancer. To date there has not been a study to directly compare TAC to DD AC-P and this trial will provide that comparison. Another potential advantage of DD AC-P is that it's reported toxicity profile provides opportunity for incorporating a fourth chemotherapy agent into the program. The anti-metabolite gemcitabine has shown promise in combination with paclitaxel for treatment of mestastatic breast cancer arguing for its potential use in the adjuvant setting. A phase 2 study of gemcitabine in combination with paclitaxel as a third-line therapy showed a response rate of 55% with a manageable toxicity profile. On the basis of the activity of the gemcitabine/paclitaxel combination demonstrated in these trials, coupled with the favorable toxicity profile of the dose-dense schedule, they propose to determine whether sequential dose-dense AC followed by DD AC-PG (Arm III) can further improve the outcome provided by both TAC and DD AC-P. The primary aims of this study are to determine whether the DD AC-PG regimen is superior to the TAC and the DD AC-P regimens in improving DFS and to compare the relative DFS of TAC and DD AC-P. Secondary aims are to determine whether DD AC-PG is superior to TAC and DD AC-P in improving overall survival, compare survival of the TAC and DD AC-P regimens Alone, and to compare the toxicities of the 3 regimens. Study Design: The study will be conducted in women with operable, invasive carcinoma of the breast with histologically positive axillary nodes. Patients will be stratified by number of positive nodes, hormone receptor status, and type of surgery and planned radiotherapy. Following stratification, patients wi11 be randomized to 1 of the 3 chemotherapy regimens. Women with ER positive and/or PR positive tumors should receive hormonal therapy for a minimum of 5 years following completion of chemotherapy. All women who have had a lumpectomy wi11 have whole breast irradiation. Chest wall and regional nodal irradiation will be prospectively determined at the discretion of the investigator and will be used as a stratification factor. The study will enroll 4800 patients.

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， 因此可以在其他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。 最近，肿瘤学家已经开始用剂量密集（DD）方案治疗乳腺癌患者。这意味着患者在更短的时间内接受化疗药物。令人惊讶的是， 患者所经历的并不更差，并且如果不是上级的话，则功效相等。研究表明，接受多西他赛/阿霉素/环磷酰胺（TAC）（I组）或dose-dense治疗的乳腺癌女性。 与既往使用的化疗方案相比，多柔比星/环磷酰胺后加DD紫杉醇（DD AC-P）（第II组）的治疗结局有所改善。不幸的是，一些妇女仍然发展局部，区域和全身性疾病复发。这一现实为继续努力进一步改善淋巴结阳性乳腺癌的治疗提供了令人信服的理由。到目前为止，还没有直接比较TAC与DD AC-P的研究，本试验将 提供这种比较。DD AC-P的另一个潜在优势是，据报道，其毒性特征为将第四种化疗药物纳入该方案提供了机会。抗代谢药吉西他滨已显示出与紫杉醇联合治疗转移性乳腺癌的前景，认为其可能用于辅助治疗。吉西他滨联合紫杉醇作为三线治疗的2期研究显示，缓解率为55%，毒性特征可控。基于吉西他滨/紫杉醇组合的活性 由于这些试验中证实了这一点，加上剂量密集方案的有利毒性特征，他们建议确定序贯剂量密集AC后接DD AC-PG（III组）是否可以进一步改善TAC和DD AC-P提供的结局。 本研究的主要目的是确定DD AC-PG方案在改善DFS方面是否上级TAC和DD AC-P方案，并比较TAC和DD AC-P的相对DFS。 目的是确定DD AC-PG在改善总生存率方面是否上级于TAC和DD AC-P，比较单独TAC和DD AC-P方案的生存率，并比较3种方案的毒性。 研究设计：本研究将在组织学阳性腋窝淋巴结的可手术浸润性乳腺癌女性患者中进行。患者将根据阳性淋巴结数量、激素受体状态、手术类型和计划的放疗进行分层。分层后，患者将被随机分配至3种化疗方案之一。ER阳性和/或PR阳性肿瘤的女性应在完成化疗后接受至少5年的激素治疗。所有做过乳房肿瘤切除术的妇女都将接受全乳照射。胸壁和区域淋巴结 辐照将由研究者自行决定，并将用作分层因素。该研究将招募4800名患者。