A Study of Cyclophosphamide, Methotrexate, Fluorouracil (CMF) for People With Breast Cancer
2026年8月12日 更新者：Memorial Sloan Kettering Cancer Center
STUDY OF DOSE DENSE CMF (Cyclophosphamide, Methotrexate, Fluorouracil) as an Alternative to AC (Doxorubicin, Cyclophosphamide) in 2 Regimens in EARLY STAGE BREAST CANCER for Patients Greater or Equal to 70
The purpose of this study is to find out if it is practical (feasible) to give dose-dense CMF (cyclophosphamide, methotrexate, and fluorouracil) in two standard chemotherapy regimens in people with breast cancer, age 70 and older.
研究概览
研究类型
介入性
注册 (估计的)
76
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Pamela Drullinsky, MD
- 电话号码：516-559-1521
- 邮箱：drullinp@mskcc.org
研究联系人备份
- 姓名：Koshy Alexander, MD, MBA
- 电话号码：646-888-3659
- 邮箱：alexandk@mskcc.org
学习地点
-
-
New Jersey
-
Basking Ridge、New Jersey、美国、07920
- 招聘中
- Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
-
接触：
- Pamela Drullinsky, MD
- 电话号码：516-559-1521
-
Middletown、New Jersey、美国、07748
- 招聘中
- Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)
-
接触：
- Pamela Drullinsky, MD
- 电话号码：516-559-1521
-
Montvale、New Jersey、美国、07645
- 招聘中
- Memorial Sloan Kettering at Bergen (Limited Protocol Activities)
-
接触：
- Pamela Drullinsky, MD
- 电话号码：516-559-1521
-
-
New York
-
Commack、New York、美国、11725
- 招聘中
- Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
-
接触：
- Pamela Drullinsky, MD
- 电话号码：516-559-1521
-
Harrison、New York、美国、10604
- 招聘中
- Memorial Sloan Kettering at Westchester (Limited Protocol Activities)
-
接触：
- Pamela Drullinsky, MD
- 电话号码：516-559-1521
-
New York、New York、美国、10065
- 招聘中
- Memorial Sloan-Kettering Cancer Center (All Protocol Activities)
-
接触：
- Pamela Drullinsky, MD
- 电话号码：516-559-1521
- 邮箱：drullinp@mskcc.org
-
Uniondale、New York、美国、11553
- 招聘中
- Memorial Sloan Kettering at Nassau (Limited Protocol Activities)
-
接触：
- Pamela Drullinsky, MD
- 电话号码：516-559-1521
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Patients must have histologically confirmed adenocarcinoma of the breast confirmed at MSK. The patient must have had diagnostic biopsy or completion of primary surgical management, within 3 months of enrollment. Results of HER-2/neu, estrogen receptor, and progesterone receptor are required for study entry.
- Patients must be ≥ 70 years of age.
- Patients must have ECOG performance status >2 (Karnofsky score of ≥ 60%).
- Patients may have received hormonal therapy for the purpose of chemoprevention.
- Adjuvant/neoadjuvant chemotherapy decision to treat based on the discretion of investigator
- Cohort 1 only: Patients have any histology except Her 2 Neu positive in the adjuvant or neoadjuvant setting
- Cohort 2 only: Patients have triple negative (ER- (10%) PR-Her 2 Neu -) in the neoadjuvant setting
- Cohort 2 only: Patients have received at least 1 dose of carboplatin/paclitaxel +/- pembrolizumab in the neoadjuvant setting
Required Organ Function
Adequate hematologic function defined as follows:
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
- Platelets ≥ 100,000 cells/mm3
Adequate renal function defined as follows:
° Creatinine clearance (CrCL) of >30 mL/min by the Cockcroft-Gault formula:
CrCl (mL/min) = [([140 - age(years)] x weight (kg))/72 x creatinine (mg/dL)] (x 0.85 for female patients)
Adequate hepatic function defined as follows:
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)
AST and ALT ≤3 x institutional ULN
- Patients or their Legally Authorized Representative must give written, informed consent indicating their understanding and willingness to participate in the study.
Exclusion Criteria:
- Stage IV breast cancer
- CARG score- high Frail 4 or more as assessed by CAIT
- Her 2 Neu positive 3+/amplified breast cancer
- No prior chemotherapy within 1 year of study enrollment
- Cohort 2 only: patients may not receive pembrolizumab during dd CMF treatment
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Cohort 1
ddCMF x 4 Cycles followed by either 4 doses of dd paclitaxel given every 2 weeks or 12 doses of paclitaxel given weekly, per investigator discretion, in the adjuvant or neoadjuvant setting
|
CMF regimen: Cyclophosphamide, Methotrexate, and Fluorouracil
Paclitaxel will be administered as an IV infusion into a peripheral or central vein.
|
|
实验性的：Cohort 2
ddCMF x 4 Cycles in the neoadjuvant setting, in participants who have received at least 1 dose of carboplatin/paclitaxel +/- pembrolizumab
|
CMF regimen: Cyclophosphamide, Methotrexate, and Fluorouracil
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of participants who have completed all four cycles of CMF
大体时间：6 months
|
Evaluate the feasibility of 4 cycles of ddCMF as an alternative to AC in 2 standard regimens in patients > or = to age 70 with breast cancer.
Feasibility is evaluated by the completion of all four cycles of CMF.
|
6 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Pamela Drullinsky, MD、Memorial Sloan Kettering Cancer Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年8月11日
初级完成 (估计的)
2030年8月11日
研究完成 (估计的)
2030年8月11日
研究注册日期
首次提交
2026年8月12日
首先提交符合 QC 标准的
2026年8月12日
首次发布 (实际的)
2026年8月17日
研究记录更新
最后更新发布 (实际的)
2026年8月17日
上次提交的符合 QC 标准的更新
2026年8月12日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- 26-303
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials.
The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov
when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required.
Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later.
Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals.
Requests may be made to: crdatashare@mskcc.org.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
是的
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