Sustainable and Efficient Platform of New Therapeutic Development for Early Breast Cancer (S-FACT)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- ctDNA clearance rate
研究概览
简要总结
Randomized phase II trial targeting early-stage breast cancer (stage II-III) applicable to preoperative chemotherapy (NAC), comparing standard treatment with multiple experimental treatments.
详细描述
This randomized phase II trial targets early-stage breast cancer (stage II-III) with preoperative chemotherapy (NAC). It compares standard treatment with multiple experimental treatments using an adaptive design, allowing new treatments to be added during or after the trial. Patients are classified by subtype and randomized between standard and experimental treatments.
The trial is flexible, permitting single or combination new drug therapies and incorporating circulating tumor DNA (ctDNA) evaluation for precise efficacy and prognosis prediction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed invasive breast carcinoma
- •Stage II or III
- •ECOG performance status of 0 or 1
排除标准
- •Continuous systemic administration (oral or intravenous) of steroid drugs or other immunosuppressants.
- •History or complication of interstitial lung disease or pulmonary fibrosis diagnosed by imaging or clinical findings.
- •Infection requiring systemic treatment.
- •Active double cancer (however, the following are not excluded: (1) Completely resected cancers: basal cell carcinoma, squamous cell carcinoma at clinical stage I, carcinoma in situ, mucosal carcinoma, superficial bladder carcinoma, (2) Gastrointestinal cancer that has been curatively resected by ESD or EMR, (3) Other cancers that have not recurred for more than 5 years).
研究组 & 干预措施
JCOG2205-TN
KEYNOTE-522 regimen: Carboplatin + paclitaxel + pembrolizumab followed by doxorubicin + cyclophosphamide + pembrolizumab
干预措施: TN (Drug)
JCOG2205-TN-1
Carboplatin + paclitaxel + pembrolizumab followed by niraparib + pembrolizumab
干预措施: TN-1 (Drug)
结局指标
主要结局
ctDNA clearance rate
时间窗: Before Neoadjuvant chemotherapy to surgery
ctDNA test was performed by Natera
pathological complete response (pCR)
时间窗: Baseline to surgery
pCR is defined as the absence of invasive cancer in the breast and sampled regional lymph nodes.
次要结局
未报告次要终点
研究者
Kazuki Nozawa
Principal Investigator
Nagoya City University