NCT07551050招募中不适用
A Real-world, Multicenter, Prospective Study to Evaluate the Patient-reported Outcome in Chinese Patients Who Received Sacituzumab Govitecan or Chemotherapy of the Physician's Choice for Metastatic Breast Cancer Progressing on First-line Treatment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Mean change from baseline in the EORTC QLQ-C30 GHS/QOL score.
研究概览
简要总结
A real-world, multicenter, prospective study to evaluate the patient-reported outcome in Chinese patients who received sacituzumab govitecan or chemotherapy of the physician's choice for metastatic breast cancer progressing on first-line treatment
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 75 years.
- •Patients have been diagnosed with metastatic HER2 negative breast cancer. HER2 status were determined locally by immunohistochemistry (IHC) of patients' primary or metastatic tumor sections. HER2-negative status was defined by IHC staining 0 to 1+ or fluorescence in situ hybridization ratio <2.0 if IHC 2+ or IHC not performed.
- •The metastatic disease was confirmed by clinical, imaging, histological, or cytological measures, including unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.
- •For patients with triple-negative breast cancer (TNBC): at least 1 line of systemic therapy in the metastatic setting; for patients with HR+/HER2- breast cancer: prior treatment with endocrine therapy and CDK4/6 inhibitors, and at least 1 line of systemic therapy in the metastatic setting.
- •At least one evaluable lesion by CT or MRI according to RECIST 1.
- •Willing to accept the treatment by the investigator based on the patient's preference, physical condition, prior treatment history, and financial circumstances.
- •Willing to use contraceptive measures during the study period.
- •Willing and able to complete electronic questionnaires/scales on a smartphone, tablet, or other electronic device.
- •All patients can provide an informed consent before enrolment and data collection.
排除标准
- •Insufficient bone marrow, hepatic, or renal function, defined as:
- •Bone marrow: White blood cell count < 3.0 × 10⁹/L, or absolute neutrophil count < 1.5 × 10⁹/L, or platelet count < 75 × 10⁹/L, or hemoglobin < 8.0 g/dL.
- •Hepatic function: Total bilirubin > 1.5 × upper limit of normal (ULN), or ALT/AST > 3.0 × ULN (or > 5.0 × ULN in the presence of liver metastases).
- •Renal function: Serum creatinine > 1.5 × ULN, or creatinine clearance < 50 mL/min.
- •History of other malignancies or hematologic malignancies.
- •Hypersensitivity to the study treatment drugs.
- •Systemic anti-tumor therapy (including chemotherapy, radiotherapy, immunotherapy, etc.) within 2 weeks prior to study drug administration.
- •Treatment with an investigational product within 4 weeks before the first treatment.
- •Presence of any toxicity from prior therapy (excluding alopecia) ≥ Grade 2 according to CTCAE version 5.0, prior to study drug administration.
- •Systemic inflammatory diseases, including but not limited to systemic lupus erythematosus, juvenile chronic arthritis, spondyloarthropathy, Crohn's disease, ulcerative colitis, psoriatic arthritis, or active vasculitis.
- •Severe psychiatric or neurological disorders, including but not limited to schizophrenia, depression, mania, Alzheimer's disease, myasthenia gravis, seizure disorders, or known conditions that may provoke seizures.
- •Pregnant or breastfeeding women.
研究组 & 干预措施
Sacituzumab Govitecan
Sacituzumab Govitecan
Chemotherapy of the physician's choice
Chemotherapy of the physician's choice, including single-agent or combination chemotherapy regimens consisting of commonly used chemotherapeutic drugs for breast cancer, such as taxanes, anthracyclines, vinorelbine, gemcitabine, capecitabine, eribulin, and cisplatin/carboplatin. Combination with other targeted therapies, including immune checkpoint inhibitors (PD-1/PD-L1 monoclonal antibodies) and bevacizumab, is also permitted.
结局指标
主要结局
Mean change from baseline in the EORTC QLQ-C30 GHS/QOL score.
时间窗: 12 weeks
Mean change from baseline in the EORTC QLQ-C30 GHS/QOL score.
次要结局
- Mean change from baseline in the EORTC QLQ-BR45 score, and time to deterioration.(12 weeks)
- Proportion of patients with clinically meaningful improvement or deterioration from baseline in the EORTC QLQ-C30 GHS/QOL score.(12 weeks)
- Number and percentage of patients with different severity levels on the PRO-CTCAE at baseline and during follow-up.(12 weeks)
- PFS(6 weeks)
- OS(6 weeks)
研究者
研究点 (1)
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