NCT07095023招募中不适用
A Single-Arm Clinical Study to Evaluate the Efficacy and Safety of Neoadjuvant Oral Paclitaxel Plus Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Injection in Patients With HER2-positive Breast Cancer
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University9 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2025年8月15日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 112
- 试验地点
- 9
- 主要终点
- Total Pathological Complete Response(tpCR)
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy and safety of oral paclitaxel plus fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in the neoadjuvant treatment of HER2+ breast cancer patients.
详细描述
OPTIMAL-BC is a multicenter, single arm study using a Simon's two-stage design evaluating neoadjuvant treatment with paclitaxel oral solution combined with subcutaneous fixed dose combination (FDC) of pertuzumab and trastuzumab every 3 weeks for 6 cycles. All subjects will undergo surgery in line with local guidelines following neoadjuvant therapy. The primary endpoint is total pathological complete response(tpCR, ypT0/is, ypN0).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-70 years old. Histologically confirmed HER2-positive invasive breast cancer with clinical stages T1c-4, N0-3, and M0 (excluding T1cN0M0), according to the 8th American Joint Committee on Cancer (AJCC) edition BC staging system HER2 overexpression was defined as immunohistochemistry (IHC) 3+ or 2+ with HER2 gene amplification, determined by fluorescence in situ hybridization (FISH).
- •Baseline left ventricular ejection fraction (LVEF) of ≥50%. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or
- •The functional level of major organs must meet the following requirements (no blood transfusion and no use of white blood cell, red blood cell and platelet-raising drugs within 2 weeks before the first dose):
- •Absolute neutrophil count ≥ 1,500/mcL
- •Platelets ≥ 100,000/mcL
- •Hemoglobin ≥ 9.0 g/dL
- •Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- •Alanine aminotransferase and aspartate aminotransferase (ALT/AST) ≤1.5×ULN
- •Blood urea nitrogen and serum creatinine ≤1.5×ULN
- •Creatinine clearance (Ccr) ≥50 ml/min (Cockcroft-Gault formula) Signature of informed consent
排除标准
- •History of invasive breast cancer. Bilateral breast cancer or inflammatory breast cancer . Prior excisional and/or incisional biopsy of the primary tumor and/or axillary lymph nodes.
- •Prior systemic therapy for breast cancer. History of life-threatening hypersensitivity reactions or known hypersensitivity to any component of the investigational drug.
- •Participation in another clinical trial of a drug or medical device within 4 weeks prior to the first dose and/or receipt of investigational drug/device during the trial.
- •Major surgery within 28 days prior to the first dose or planned major surgery during the study period.
- •History of other malignancies within the past 5 years, except for carcinoma in situ of the cervix, non-melanoma skin cancer, localized prostate cancer, or ductal carcinoma in situ.
- •Active tuberculosis or other severe infectious diseases requiring systemic treatment, including but not limited to bacteremia, severe pneumonia, and other serious infections.
- •History of immunodeficiency or autoimmune diseases, including but not limited to HIV infection (HIV antibody positive), systemic lupus erythematosus, rheumatoid arthritis, or history of organ transplantation.
- •History of cardiovascular or cerebrovascular diseases, including:
- •Unstable angina;
- •Clinically significant arrhythmias requiring medication;
- •Myocardial infarction within the past 6 months;
- •Heart failure or second-degree or higher atrioventricular block;
- •Cerebral infarction (excluding lacunar infarction) or cerebral hemorrhage within the past 6 months.
- •Poorly controlled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg despite regular medication), or history of hypertensive crisis or hypertensive encephalopathy.
- •Unsuitability for oral administration of the investigational drug, as judged by the investigator, including:
- •Clinically significant or uncontrolled congenital or acquired gastrointestinal diseases;
- •Diseases that may affect drug administration, gastric entry, or absorption (e.g., intestinal obstruction, Crohn's disease, ulcerative colitis).
- •Pregnant or breastfeeding women; women of childbearing potential with a positive pregnancy test at screening; or those unwilling to use effective contraception during the study and for 6 months after the last dose.
研究组 & 干预措施
Oral Paclitaxel plus Subcutaneous Pertuzumab/Trastuzumab
Experimental
Paclitaxel oral solution plus subcutaneous fixed-dose combination of pertuzumab and trastuzumab
干预措施: Paclitaxel oral solution plus Subcutaneous Pertuzumab/Trastuzumab (Drug)
结局指标
主要结局
Total Pathological Complete Response(tpCR)
时间窗: Approximately 6 months from first dose of study drug following surgery or early withdrawal, whichever occurred first (Surgery was performed within 6 weeks after neoadjuvant treatment)
It refers to the absence of any invasive cancer in the resected specimens (breast + axilla) after completion of neoadjuvant chemotherapy and surgery (i.e., ypT0/is, ypN0).
次要结局
- Overall Response Rate(ORR)(Approximately 6 months from first dose of study drug following surgery or early withdrawal, whichever occurred first (Surgery was performed within 6 weeks after neoadjuvant treatment))
- Event-Free Survival (EFS)(Up to 3 years)
- Overall survival(OS)(Up to 3 years)
- Health Related Quality of Life (QoL)(From baseline to 30 days after completion of treatment or the last follow-up visit)
- Adverse Events(From first dose of study drug to 30 days after completion of treatment)
研究者
Liu Qiang
Director
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
研究点 (9)
Loading locations...
相似试验
已完成
1 期
Efficacy of VIC Regimen in BRAF Mutant Metastatic Colorectal CancerColorectal Cancer MetastaticNCT04790448Sun Yat-sen University37
招募中
不适用
Safety and Efficacy of Anti-BCMA-GPRC5D CAR-T Cells Therapy in the Treatment of r/r MMRelapsed/Refractory Multiple MyelomaNCT06515262920th Hospital of Joint Logistics Support Force of People's Liberation Army of China10
招募中
2 期
A Clinical Study to Evaluate the Safety and Efficacy of BCMA-GPRC5D CAR-T in Patients With Relapsed/Refractory Multiple Myeloma Who Received Three or More Lines of TherapyMultiple MyelomaNCT05998928Wuhan Union Hospital, China10
已完成
2 期
Efficacy and Safety Study of Cediranib in Combination With Olaparib in Patients With Recurrent Platinum-Resistant Ovarian CancerRecurrent Platinum Resistant Ovarian CancerNCT02889900AstraZeneca62
尚未招募
2 期
Assess the Efficacy of Radiotherapy and Sequential Chemotherapy and AK104 Before TME Surgery for Local CRC（AK104-IIT-13）Locally Advanced Rectal CancerNCT05794750JIN JING50