NCT07760844尚未招募3 期
A Randomized Phase III Study of Trastuzumab Rezetecan With or Without Everolimus as First- to Third-Line Treatment for Luminal Androgen Receptor Subtype of Triple-Negative Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 180
- 主要终点
- Progression Free Survival(PFS)
研究概览
简要总结
This study is a prospective, open-label, phase III, randomized controlled clinical trial. It is planned to screen patients with inoperable locally advanced or metastatic triple-negative breast cancer of the LAR subtype. A total of 180 patients are planned to be enrolled.
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
- •Inclusion Criteria:
- •Female patients aged ≥18 years and ≤70 years;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;
- •Life expectancy of at least 3 months;
- •Histologically confirmed invasive triple-negative breast cancer (defined as breast cancer with estrogen receptor [ER], progesterone receptor [PR], and human epidermal growth factor receptor 2 [HER-2] all determined to be negative by pathological testing. Specifically: ER-negative: IHC <1%; PR-negative: IHC <1%; HER2-negative: IHC -/+ or IHC ++ with FISH/CISH negative. All specimens must be verified as the LAR subtype of the Fudan quadruple molecular classification by the Precision Medicine Center/Department of Pathology at the study's participating center);
- •Tumor stage: recurrent or metastatic breast cancer; for locally recurrent disease, radical surgical resection must be confirmed by the investigator to be not feasible. Number of prior lines of therapy in the advanced setting ≤2;
- •Patients must have at least one lesion (measurable and/or non-measurable) that has not been previously irradiated, can be accurately assessed at baseline by CT/MRI, and can be repeatedly evaluated according to RECIST 1.1;
- •Adequate major organ function, meeting the following criteria:
- •Hematological parameters: hemoglobin (HB) ≥90 g/L (without blood transfusion within 14 days); absolute neutrophil count (ANC) ≥1.5×10⁹/L; platelet count (PLT) ≥75×10⁹/L;Biochemical parameters: total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN; in the presence of liver metastases, ALT and AST ≤5×ULN; serum creatinine (Cr) ≤1×ULN, and calculated creatinine clearance >50 mL/min (Cockcroft-Gault formula);
- •No prior radiotherapy, endocrine therapy, molecular targeted therapy, or surgery within 3 weeks before study initiation, and recovery from acute toxicities of prior treatment (if surgery was performed, the wound must be completely healed); no peripheral neuropathy or only grade I peripheral neurotoxicity;
- •Female subjects of childbearing potential must agree to use a medically accepted contraceptive method during the study treatment period and for at least 3 months after the last dose of study drug;
- •Subjects must voluntarily participate in this study, sign the informed consent form, have good compliance, and be willing to cooperate with follow-up.
排除标准
- •Patients with any of the following criteria will be excluded from this study:
- •Known central nervous system (CNS) metastases or a history of CNS metastases prior to screening. For patients with clinically suspected CNS metastases, contrast-enhanced CT or contrast-enhanced magnetic resonance imaging (MRI) must be performed within 28 days before the first dose to rule out CNS metastases;
- •History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina pectoris, myocardial infarction within the past 6 months, or ventricular arrhythmias;
- •Persistent adverse events of Grade ≥1 resulting from prior treatment. Exceptions to this are alopecia or conditions that the investigator deems should not preclude enrollment. Such cases should be clearly documented in the investigator's notes;
- •Major surgery (excluding minor procedures such as placement of vascular access) within 3 weeks before the first cycle of study treatment;
- •Pregnant or lactating patients;
- •Other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin;
- •Presence of third-space fluid accumulation (e.g., massive pleural effusion or ascites) that cannot be controlled by drainage or other methods;
- •Participation in another anti-tumor drug clinical trial within 3 weeks before the first use of the study drug;
- •Long-term unhealed wounds or incompletely healed fractures;
- •Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, or HBV DNA ≥500 IU/mL, or chronic hepatitis with abnormal liver function;
- •History of allergic constitution, known allergy to any component of the study drug regimen, or history of allergy to other monoclonal antibodies;
- •History of gastrointestinal bleeding within the past 6 months, or clear evidence of a tendency for gastrointestinal bleeding, such as esophageal varices at risk of bleeding, active local ulcerative lesions, or fecal occult blood test ≥ (++). Patients with fecal occult blood test (+) should undergo gastroscopy;
- •Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to study enrollment;
- •Urinalysis showing urine protein ≥ (++), or confirmed 24-hour urine protein quantification >1.0 g;
- •Hypertension that cannot be controlled to within normal range with antihypertensive medication (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg);
- •Prior use of anti-angiogenic agents or prior exposure to an antibody-drug conjugate (ADC) with a topoisomerase I inhibitor as the payload
研究组 & 干预措施
Arm-A
Experimental
SHRA1811 at 4.8 mg/kg, administered by intravenous infusion on Day 1, with a 3-week treatment cycle. Everolimus administered at a fixed dose of 5 mg orally, once daily, continuously.
干预措施: SHR- A1811+ eve (Drug)
Arm-B
Active Comparator
SHRA1811 at 4.8 mg/kg, administered by intravenous infusion on Day 1, with a 3-week treatment cycle.
干预措施: SHR- A1811 (Drug)
结局指标
主要结局
Progression Free Survival(PFS)
时间窗: 24 months
Time to progressive disease (according to RECIST1.1)
次要结局
- Objective response rate (ORR)(24 months)
- Duration of Response (DoR)(24 months)
- Disease Control Rate (DCR)(24 months)
- Overall survival (OS)(24months)
- Safety and Tolerability(24months)
研究者
Zhimin Shao
Director of General Surgery of Fudan Shanghai Cancer Center
Fudan University
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