NCT07018427进行中（未招募）不适用
Efficacy and Safety of Sacituzumab Govitecan in Heavily Pretreated Unresectable Locally Advanced, Recurrent, or Metastatic HER2-Negative Breast Cancer: A Multicenter Real-World Study
Peking University Cancer Hospital & Institute1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年5月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Real world progression free survival (rwPFS)
研究概览
简要总结
This multicenter observational real-world study is planned to enroll 100 patients, divided into two cohorts: the triple-negative breast cancer (TNBC) cohort and the hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer (HR+/HER2- BC) cohort. The study aims to evaluate the efficacy and safety of sacituzumab govetican (SG) monotherapy or combination regimens in patients with unresectable locally advanced, recurrent, or metastatic HER2-negative breast cancer within a real-world context.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age and Gender Male or female aged 18 years or older.
- •Pathological Diagnosis and Classification Criteria (Must Meet Either Cohort Condition) 2.1 Triple-Negative Breast Cancer (TNBC) Cohort
- •Histologically/cytologically confirmed triple-negative breast cancer (TNBC) by pre-SG biopsy/pathology report, with the following criteria:
- •HER2-negative: Immunohistochemistry (IHC) score of 0 or 1+; if IHC score is 2+, HER2 negativity must be confirmed by fluorescence in situ hybridization (FISH).
- •Estrogen and progesterone receptor-negative: <1% of cells express hormone receptors as determined by IHC.
- •Presence of locally advanced, recurrent, or metastatic disease (locally advanced disease must be confirmed by investigators as ineligible for curative resection).
- •2.2 Hormone Receptor-Positive/HER2-Negative Breast Cancer (HR+/HER2- BC) Cohort
- •Histologically/cytologically confirmed HR+/HER2- breast cancer by pre-SG biopsy/pathology report, with the following criteria:
- •HER2-negative: Immunohistochemistry (IHC) score of 0 or 1+; if IHC score is 2+, HER2 negativity must be confirmed by fluorescence in situ hybridization (FISH).
- •HR-positive: Hormone receptor positivity (HR, including ER or PR status) is defined as ≥1% cell expression by IHC.
- •Presence of locally advanced, recurrent, or metastatic disease (locally advanced disease must be confirmed by investigators as ineligible for curative resection).
- •Treatment Protocol Requirements Planned to receive SG monotherapy or combination therapy.
- •Other Enrollment Criteria Willing to participate in the study, sign the informed consent form, and demonstrate good compliance.
排除标准
- •Pregnant or lactating women.
- •Known allergy to sacituzumab govitecan (SG) or any of its components.
- •History of other malignancies, except the following:
- •Cured basal cell carcinoma, squamous cell skin carcinoma, cervical in situ carcinoma, or papillary thyroid carcinoma.
- •A second primary cancer that has been completely cured with a tumor-free interval of ≥5 years.
- •Other malignancies where the primary tumor source of metastatic foci has been clearly identified by investigators.
- •Diagnosis of other malignancies within the past 5 years
- •Current participation in other interventional clinical studies.
- •Presence of acute or chronic infections, or coexisting serious diseases (such as decompensated heart, lung, liver, or renal failure), assessed by investigators as incompatible with tolerating the study treatment.
- •Mental illness or psychiatric disorders leading to poor compliance, inability to cooperate with the study, or inability to describe treatment responses.
- •Modification of the treatment regimen after SG administration for reasons other than disease progression.
- •Any other circumstances deemed by investigators as likely to interfere with study evaluation, affect subject safety, or render the patient unsuitable for enrollment.
研究组 & 干预措施
Patients received SG
HER2-negative breast cancer patients who received SG treatment in the advanced stage
干预措施: Sacituzumab Govitecan Monotherapy or Combination Therapy (Drug)
结局指标
主要结局
Real world progression free survival (rwPFS)
时间窗: 12 months after the last patient was enrolled
The time interval from the date of Sacituzumab Govitecan initiation until date of progressive disease (PD) or death from any causes, whichever occurred first.
次要结局
- Real world overall survival (rwOS)(up to 48 months from the initiation of the study treatment.)
- Real world objective response rate (rwORR)(approximately up to 24 weeks from the initiation of the study treatment.)
- Number of patients with adverse events(approximately up to 68 weeks from the initiation of the treatment.)
研究者
songguohong
Chief Physician, Deputy Director of the Department, Medical Oncology of Breast Cancer
Peking University Cancer Hospital & Institute
研究点 (1)
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