Real-world Patient-reported Outcome of Sacituzumab Govitecan in Chinese Metastatic Breast Cancer

Официальное название

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

Обзор

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

Первичные конечные точки

• Mean change from baseline in the EORTC QLQ-C30 GHS/QOL score. [Срок оценки: 12 weeks]

Вторичные конечные точки (5)

• Mean change from baseline in the EORTC QLQ-BR45 score, and time to deterioration. [Срок оценки: 12 weeks]
• Proportion of patients with clinically meaningful improvement or deterioration from baseline in the EORTC QLQ-C30 GHS/QOL score. [Срок оценки: 12 weeks]
• Number and percentage of patients with different severity levels on the PRO-CTCAE at baseline and during follow-up. [Срок оценки: 12 weeks]
• PFS [Срок оценки: 6 weeks]
• OS [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

• 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.
• ECOG-PS ≤2
• 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 1.1.
• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Fudan University Shanghai Cancer Center — Шанхай

Идентификаторы

NCT: NCT07551050 · SCRPC-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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