NCT06913777招募中3 期
An Open-Label, Multicenter, Randomized Controlled Phase III Clinical Study of Neoadjuvant Chemotherapy Based on SNF Classification With or Without Precision Medicine Agents for Early-Stage or Locally Advanced HR+/HER2- Breast Cancer
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 404
- 试验地点
- 1
- 主要终点
- Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 ((i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery)
研究概览
简要总结
This study is a prospective, open-label, multicenter, randomized controlled Phase III clinical trial designed to compare the efficacy and safety of neoadjuvant chemotherapy based on SNF classification with or without precision medicine agents in previously untreated patients with early-stage or locally advanced HR+/HER2- breast cancer.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Stage IV (metastatic) breast cancer.
- •History of invasive breast cancer.
- •History of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS).
- •Prior systemic therapy for breast cancer (chemotherapy, endocrine therapy, or anti-HER2 therapy), or prior excisional biopsy/radiotherapy of primary breast tumor and/or axillary lymph nodes (excluding diagnostic biopsy for primary breast cancer or surgery for benign breast tumors).
- •Other malignancies within the past 5 years (except cured cervical carcinoma in situ or non-melanoma skin cancer).
- •Participation in any other investigational drug study within 4 weeks prior to randomization.
- •Peripheral neuropathy ≥ Grade 2 (per NCI-CTCAE v5.0).
- •Severe cardiovascular or cerebrovascular diseases within 6 months prior to randomization, including but not limited to:
- •Congestive heart failure,
- •Unstable angina,
- •Severe uncontrolled arrhythmias,
- •Clinically significant valvular disease,
- •Uncontrolled severe hypertension,
- •Myocardial infarction, or
- •Cerebrovascular accident.
- •Any severe uncontrolled systemic disease that may interfere with the treatment plan, including significant cardiovascular, pulmonary, or metabolic disorders.
- •Major surgery within 4 weeks prior to randomization without full recovery, or anticipated need for major surgery during the study treatment.
- •Systemic corticosteroid use (>10 mg prednisone equivalent daily) or other immunosuppressants within 2 weeks prior to the first dose of study drug (except for prophylactic anti-allergy or antiemetic purposes).
- •* Inhaled/topical steroids or physiologic steroid replacement doses (≤10 mg/day prednisone equivalent) are permitted in the absence of active autoimmune disease.
- •Administration of anti-cancer vaccines or live vaccines within 4 weeks prior to the first dose of study drug.
- •Active autoimmune disease or history of autoimmune disorders (e.g., interstitial lung disease, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyper/hypothyroidism), EXCEPT:
- •Vitiligo,
- •Childhood asthma/allergies resolved without intervention in adulthood,
- •Stable hypothyroidism on hormone replacement,
- •Type 1 diabetes on stable insulin therapy.
- •Exclusion: Asthma requiring bronchodilators.
- •Immunodeficiency (e.g., HIV-positive, congenital/acquired immune deficiency) or history of organ/allogeneic bone marrow transplantation.
- •History of interstitial lung disease (except radiation pneumonitis without steroid treatment) or non-infectious pneumonitis.
- •Active liver disease, including:
- •Hepatitis B (HBsAg-positive with HBV-DNA ≥1000 IU/mL),
- •Hepatitis C (HCV-Ab-positive with detectable HCV-RNA), or
- •Autoimmune hepatitis.
- •Pregnancy or lactation.
- •Known hypersensitivity to the study drug(s), its excipients, or severe allergic reactions to monoclonal antibodies.
- •History of substance abuse, alcoholism, or drug addiction.
- •Uncontrolled psychiatric/neurological disorders (e.g., epilepsy, dementia) or poor compliance.
- •Any other condition that may increase study risk, interfere with treatment/outcomes, or render the patient unsuitable for participation per investigator's judgment.
研究组 & 干预措施
Control
Active Comparator
chemotherapy (wP-EC）
干预措施: Chemotherapy (wP-EC) (Drug)
Precision group
Experimental
chemotherapy + target therapy
干预措施: Chemotherapy (wP-EC) (Drug)
结局指标
主要结局
Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 ((i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery)
时间窗: Up to approximately 1 year
pCR rate after neoadjuvant treatment, defined as the proportion of participants who have no evidence by H\&E staining of residual invasive disease in the complete resected breast specimen and all sampled regional lymph nodes (ypT0/Tis ypN0) by investigator assessment following completion of neoadjuvant therapy.
次要结局
- Overall Survival (OS)(Approximately 5 years)
- Objective Response Rate (ORR)(Approximately 1 year)
- Event-free survival (EFS) rate at 12, 24, 36-month(Up to approximately 3 years)
- Invasive disease-free survival (IDFS) rate at 12, 24, 36-month(Up to approximately 3 years)
- Safety including adverse events (AEs), severe adverse events (SAEs) and adverse events of special interest (AESI).(Up to approximately 1.5 years)
研究者
Zhimin Shao
Director of General Surgery of Fudan Shanghai Cancer Center
Fudan University
研究点 (1)
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