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临床试验 NCT07217990 (NoCUT-BC) 针对乳腺癌，HER2阳性乳腺癌，三阴性乳腺癌目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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俄亥俄州立大学Neoadjuvant Complete Response Customized Treatment Approach for Definitive Management of Breast Cancer (NoCUT-BC)
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临床试验NCT07217990 (NoCUT-BC)旨在研究治疗，主要针对乳腺癌，HER2阳性乳腺癌，三阴性乳腺癌。这是一项I期 (第一期) II期 (第二期) 干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2025年12月15日开始，预计招募84名患者。该研究由俄亥俄州立大学主导，计划于2027年12月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年10月17日。
简要概括
This study will evaluate the efficacy and non-inferiority of a non-surgical approach for the treatment of patients with locally advanced breast cancer.
详细描述
Primary Objective: To determine if a non-surgical approach to breast cancer patients with an exceptional response to NAC leads to similar recurrence rates compared to standard of care (SOC).
Exploratory Objectives
- To study personalized predictive biomarkers of response to chemotherapy and predictors of residual disease from tumor samples and circulating biomarkers.
- To validate our internally developed deep learning model to predict pathological complete response (pCR) postNAC in breast cancer patients.
Outline: This is a phase II trial that will accrue up to 84 participants. Patients will receive standard of care (SOC) neoadjuvant chemotherapy and will be evaluated for enhanced clinical complete response (ecCR) after treatment. The ecCR will be evaluated using a trimodal approach, which includes the use to Magnetic Resonance Imaging (MRI), image-guided biopsy, and circulating tumor DNA (ctDNA) analysis. Participants who achieve an ecCR will be placed in the non-surgical arm (Arm A), while those who do not achieve an ecCR will be placed in the surgical arm (Arm B).
官方标题
Neoadjuvant Complete Response Customized Treatment Approach for Definitive Management of Breast Cancer
疾病
乳腺癌HER2阳性乳腺癌三阴性乳腺癌其他研究标识符
- NoCUT-BC
- OSU-25103
- NCI-2025-07434 (注册标识符) (CTRP (Clinical Trial Reporting Program))
NCT编号
实际开始日期
2025-12-15
最近更新发布
2025-10-17
预计完成日期
2027-12-31
计划入组人数
84
研究类型
干预性研究
试验分期 (阶段)
I期 (第一期)
II期 (第二期)
II期 (第二期)
试验状态
尚未招募
主要目的
治疗方法
分配方式
非随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Arm A (eeCR, non-surgical) Patients will receive standard of care (SOC) neoadjuvant chemotherapy and will be evaluated for enhanced clinical complete response (ecCR) after treatment. Participants who achieve an ecCR will be placed in the non-surgical arm. Participants will receive radiation therapy and routine and additional screening MRIs during follow up. | 新辅助化疗 Participants will receive standard of care neoadjuvant chemotherapy 放射治疗 Radiotherapy simulation parameters will be at the discretion of the treating physician to account for the patient's body habitus, tumor bed location, and tolerability of the prone or supine positions, however, the recommended approach will be whole-breast RT (WBRT) in the prone position, for cT1-3 N0 patients who achieve ecCR. For cT1-2 N1 patients who achieve ecCR WBRT with nodal inclusion and lymph node boost will be performed in the supine position. 磁共振成像 Participants will undergo MRI 活检 Participants undergo biopsy 生物样本采集 Participants undergo blood and plasma collection |
实验性Arm B (non-eeCR, surgical) Patients will receive standard of care (SOC) neoadjuvant chemotherapy and will be evaluated for enhanced clinical complete response (ecCR) after treatment. Participants who do not achieve an ecCR will be placed in the surgical arm. Participants will undergo a lumpectomy or mastectomy, receive radiation therapy, and routine follow-up. | 新辅助化疗 Participants will receive standard of care neoadjuvant chemotherapy 放射治疗 Radiotherapy simulation parameters will be at the discretion of the treating physician to account for the patient's body habitus, tumor bed location, and tolerability of the prone or supine positions, however, the recommended approach will be whole-breast RT (WBRT) in the prone position, for cT1-3 N0 patients who achieve ecCR. For cT1-2 N1 patients who achieve ecCR WBRT with nodal inclusion and lymph node boost will be performed in the supine position. 磁共振成像 Participants will undergo MRI Breast Cancer Surgery Participants will undergo surgery to treat their breast cancer. Either a lumpectomy or a mastectomy will be performed. 活检 Participants undergo biopsy 生物样本采集 Participants undergo blood and plasma collection |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Disease-Free Rate | The study endpoints of disease-free rate and locoregional control will be determined in patient follow up by utilizing MRIs, annual mammograms and clinical assessments in conjunction with ctDNA status. | At 12 months |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Locoregional control | The study endpoints of disease-free rate and locoregional control will be determined in patient follow up by utilizing MRIs, annual mammograms and clinical assessments in conjunction with ctDNA status. | At 2, 3 and 5 years |
Disease-free survival | Survival analysis will be conducted for time to event data, and the disease control or survival rate at specific times will be estimated based on the survival analysis along with the 95% CI. | Up to 5 years |
Treatment related adverse events | Toxicities will be recorded using CTCAE v5.0 | Up to 5 years |
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 years or older
- Early-stage breast cancer diagnosis (cT1-3 N0 or cT1-2 N1) and a Human Epidermal Receptor 2 (HER2)-positive or triple negative breast cancer (TNBC) tumor molecular subtype
- Planning to receive neoadjuvant chemotherapy (NAC) and radiation therapy (RT)
- Pregnancy or lactation
- Inmate or prisoner
- Treatment with an investigational drug or other intervention throughout their breast cancer treatment
- Patients with skin involvement and/or distant metastases
俄亥俄州立大学455 个活跃的临床试验可供探索Gateway for Cancer Research研究责任方
Sachin Jhawar, 主要研究者, Principal Investigator, Ohio State University Comprehensive Cancer Center
研究中心联系人
联系人: The Ohio State University Comprehensive Cancer Center, 800-293-5066, [email protected]
1 位于 1 个国家/地区的研究中心
Ohio
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, 43210, United States
Sachin Jhawar, MD, 联系人, [email protected]
Sachin Jhawar, MD, 主要研究者