NCT06878625招募中2 期
A Multicenter, Prospective, Cohort Study Evaluating the Efficacy of Trop-2 ADC Combination Therapy in Advanced Triple-Negative Breast Cancer
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2024年12月6日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS) as Assessed by Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
研究概览
简要总结
Research purposes: the research design in the late more than 2 lines TNBC prospective, multicenter, cohort study, respectively to observe Trop2 - ADC joint PD - 1 single or combined anti-angiogenesis drugs (macromolecular single bevacizumab or small molecules TKI resistance, for, as the default layered) the efficacy and safety. Indications: Trop2 - ADC joint PD - 1 single or combined anti-angiogenesis drugs (macromolecular single bevacizumab or small molecules TKI resistance, for, as the default layered) treat above 2 late three negative breast cancer (TNBC).
详细描述
- Study Population
- Eligible Participants: Patients with triple - negative metastatic breast cancer at the second line of treatment or higher. Triple - negative invasive breast cancer is histologically confirmed, defined as immunohistochemical detection revealing estrogen receptor (ER) < 10%, progesterone receptor (PR) < 10%, and HER2 0 - 1+ or HER2 2+ with negative fluorescence in situ hybridization (FISH) or chromogenic in situ hybridization (CISH) results, in accordance with the 2018 ASCO - CAP HER2 - negative identification guidelines.
- Experimental Design
- Study Type: Multicenter, prospective cohort study.
- Sample Size Determination
- The sample size is calculated based on the primary endpoint of progression - free survival (PFS). Drawing on data from ASCENT (a confirmatory phase III study on the efficacy in triple - negative breast cancer) and EVER - 132 - 001 (a Chinese population bridging study presented at the ESMO Congress), the PFS of sacituzumab govitecan monotherapy in metastatic triple - negative breast cancer (mTNBC) is approximately 5.6 months.
- Assuming a hazard ratio of 0.70 in each cohort (median PFS value of 8 months vs. 5.6 months), to detect a statistically significant difference between the trial group and the sacituzumab govitecan monotherapy control group at a one - sided significance level of 0.05 and a power of 80%, 51 PFS events are required.
Given an enrollment period of 18 months and a total study duration of 30 months, 69 subjects are needed for each cohort. 4. Dosage Regimens
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Aged between 18 and 70 years.
- •Histologically confirmed triple-negative invasive breast cancer, defined as immunohistochemical detection of ER < 10%, PR < 10%, HER2 0-1+ or HER2 2+ with negative FISH or CISH results, in accordance with the 2018 ASCO-CAP HER2-negative identification guidelines.
- •Patients with locally advanced or metastatic breast cancer who have undergone radical surgery; patients received at least one but no more than two lines of chemotherapy in the advanced treatment phase. Early-stage triple-negative breast cancer patients who experienced disease progression within one year after neoadjuvant or adjuvant therapy are also eligible.
- •No prior use of immunotherapy or anti-angiogenic drugs.
- •At least one measurable lesion based on RECIST 1.1 criteria.
- •No contraindications to chemotherapy, immunotherapy, or anti-angiogenic therapy.
- •Stable or asymptomatic brain metastases are permitted.
- •ECOG Performance Status (PS) score of 0-2; predicted survival exceeding 12 weeks.
- •All acute toxicities from previous anticancer therapies must have resolved to Grade ≤1 per protocol criteria (excluding alopecia) before screening.
- •Women of childbearing potential must agree to use medically approved contraception during treatment and for at least three months post-treatment.
- •Adequate organ function, meeting the following criteria: Hemoglobin ≥90 g/L without transfusion within 14 days; Absolute Neutrophil Count (ANC) ≥1.5×10^9/L; Platelets ≥75×10^9/L; Total Bilirubin ≤1.5×ULN; AST and ALT ≤3×ULN (≤5×ULN if liver metastasis present); Serum Creatinine ≤1×ULN; Left Ventricular Ejection Fraction (LVEF) ≥50%.
- •Participants were voluntarily enrolled in this study, demonstrated excellent adherence, and actively participated in safety and survival follow-up assessments.
排除标准
- •Uncontrolled central nervous system metastasis (symptomatic or requiring glucocorticoids or mannitol for symptom management);
- •Symptomatic third-space effusions, including pericardial, pleural, and peritoneal effusions, that cannot be adequately managed by drainage or other therapeutic interventions;
- •Participation in another clinical trial within 30 days prior to enrollment;
- •History of other malignancies within the past 5 years, excluding adequately treated cervical carcinoma in situ, skin squamous cell carcinoma, thyroid carcinoma, or controlled basal cell carcinoma;
- •Uncontrolled cardiac conditions, such as: (1) heart failure classified as NYHA class II or higher; (2) unstable angina; (3) myocardial infarction within the past year; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; (5) QTc interval greater than 470 ms;
- •Arterial or venous thrombotic events within 24 weeks preceding informed consent, including cerebrovascular accidents (e.g., transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism.
- •Within 24 weeks prior to signing the informed consent form (ICF), a history of any of the following conditions: peptic ulcer, gastrointestinal perforation, corrosive esophagitis or gastritis, inflammatory bowel disease, diverticulitis, abdominal fistula, tracheoesophageal fistula, or intra-abdominal abscess.
- •Presence of factors that significantly impair oral drug absorption, such as inability to swallow, chronic diarrhea, or intestinal obstruction.
- •Patients with a documented history of allergy may have potential hypersensitivity or intolerance to gozzatuzumab, toripalimab, bevacizumab, or anlotinib.
- •Active infection with human immunodeficiency virus (HIV), active hepatitis B (hepatitis B surface antigen positive and HBV DNA ≥500 IU/ml), or hepatitis C (hepatitis C antibody positive and detectable HCV RNA).
- •Pregnant women, lactating women, fertile women with a positive baseline pregnancy test, or women of childbearing age who are unwilling to use effective contraception for the duration of the trial.
- •Presence of concomitant diseases (e.g., poorly controlled hypertension, severe diabetes, neurological or psychiatric disorders) or any other condition that, in the investigator's judgment, could compromise subject safety, confound study results, or prevent subjects from completing the study.
研究组 & 干预措施
Sacituzumab govitecan combined with Toripalimab
Experimental
Sacituzumab govitecan (Trop-2 ADC) : 10mg/kg on days 1 and 8, intravenous infusion, every 3 weeks for a treatment cycle.
Toripalimab 240 mg was given intravenously on day 1 of each cycle, every 3 weeks for a treatment cycle.
干预措施: Sacituzumab Govitecan combined with Toripalimab (Combination Product)
Sacituzumab govitecan combined with anti-angiogenesis
Experimental
Sacituzumab govitecan (Trop-2 ADC) : 10mg/kg on days 1 and 8, intravenous infusion, every 3 weeks for a treatment cycle.
Antiangiogenesis targeted drugs: Bevacizumab or Anlotinib Hydrochloride, according to the standard dose treatment.
干预措施: Sacituzumab govitecan combined with anti-angiogenesis (Combination Product)
结局指标
主要结局
Progression Free Survival (PFS) as Assessed by Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
时间窗: Until progression or death, up to approximately 60 months
PFS is defined as time from date of randomization until the date of first objective progressive disease (PD) by investigator assessment according to RECIST v1.1 or death from any cause, whichever comes first.
次要结局
- Objective Response Rate (ORR) as Assessed by Investigator per RECIST Version 1.1(Until progression, up to approximately 60 months)
- Overall Survival (OS)(Until death, up to approximately 60 months)
研究者
Chunfang Hao
Associate Chief Physician, Department of Breast Oncology, Tianjin Medical University Cancer Institute and Hospital
Tianjin Medical University Cancer Institute and Hospital
研究点 (1)
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