A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Trial Of JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 87
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
This study is a randomized controlled, open-label, multicenter phase III clinical study evaluating the efficacy and safety of chemotherapy selected by investigator JSKN003 s in subjects with recurrent or metastatic breast cancer who have previously failed first- or second-line chemotherapy in subjects with recurrent or metastatic breast cancer who have failed prior first- or second-line chemotherapy.
The study planned to enroll 408 subjects in a 1:1 ratio and stratified block randomization method assigned to:
- Experimental group: JSKN003 monotherapy
- Control group: investigator's chosen chemotherapy drug (capecitabine, gemcitabine, vinorelbine, docetaxel, albumin-bound paclitaxel, or eribulin) monotherapy
详细描述
This study is a randomized controlled, open-label, multicenter phase III clinical study evaluating the efficacy and safety of chemotherapy selected by investigator JSKN003 s in subjects with recurrent or metastatic breast cancer who have previously failed first- or second-line chemotherapy in subjects with recurrent or metastatic breast cancer who have failed prior first- or second-line chemotherapy.
The study planned to enroll 408 subjects in a 1:1 ratio and stratified block randomization method assigned to:
- Experimental group: JSKN003 monotherapy
- Control group: investigator's chosen chemotherapy drug (capecitabine, gemcitabine, vinorelbine, docetaxel, albumin-bound paclitaxel, or eribulin) monotherapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. The subject is able to understand the informed consent form, voluntarily participate and sign the informed consent form.
- •2. The subject ≥ 18 years old on the day of signing the informed consent form, male or female.
- •3. Unresectable locally recurrent or metastatic breast cancer, previous histopathological reports of HER2 IHC 1+ or 2+ and ISH-, previous histopathological reports have not been diagnosed as HER2 IHC 3+ or 2+ and ISH+.
- •4. Have received at least 1 to 2 lines of chemotherapy regimens for breast cancer in the relapse/metastatic stage.
- •5. Willing to provide sufficient archived tumor pathology specimens for central laboratory detection of HER2 status.
- •6. Documented radiographic disease progression (during or after the most recent treatment).
- •7. At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria.
- •8. Expected survival ≥ 3 months.
- •ECOG score of 0 or 1 within 14 days prior to administration.
- •Female subjects of childbearing potential or male subjects of fertile partner consent to use highly effective contraception from the signing of informed consent.
- •11. Laboratory tests within 14 days before administration and cardiac function tests within 28 days meet the criteria.
- •12. Have sufficient elution of previous treatment before administration.
排除标准
- •1. Untreated, or unstable brain parenchymal metastases, spinal cord metastases or compression, cancerous meningitis.
- •2. Patients with only skin lesions as target lesions.
- •Those with a history of other primary malignant tumors within 5 years before administration.
- •4. Selection of the control drug by the investigator who is not suitable for the protocol prescribed.
- •5. Previous use of antibody conjugates containing topoisomerase I inhibitors.
- •There is a third gap fluid that cannot be controlled by drainage, etc.
- •Previous or current interstitial pneumonia/lung disease requiring systemic hormone therapy.
- •8. Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors that affect oral administration and absorption of the drug.
- •9. Previous or current autoimmune disease.
- •Have uncontrolled comorbidities.
- •The toxicity of previous antitumor therapy has not been restored to grade ≤1 (NCI-CTCAE v5.0).
- •12. History of previous immunodeficiency.
- •History of life-threatening allergic reactions or known ≥ grade 3 allergy to any component or excipient in the investigational pharmaceutical formulation.
- •14. Other conditions that the investigators believe will affect the safety or adherence to drug treatment in this study, including but not limited to psychiatric disorders, alcohol or drug abuse.
研究组 & 干预措施
JSKN003
Administered intravenously according to protocol.
干预措施: JSKN003 (Drug)
The chemotherapy chosen by the investigator
The mono-chemotherapy drugs selected by the investigators included capecitabine, gemcitabine, vinorelbine, docetaxel, albumin-bound paclitaxel, or eribulin. The option should be determined before randomization.
干预措施: Capecitabine tablets (Drug)
The chemotherapy chosen by the investigator
The mono-chemotherapy drugs selected by the investigators included capecitabine, gemcitabine, vinorelbine, docetaxel, albumin-bound paclitaxel, or eribulin. The option should be determined before randomization.
干预措施: Gemcitabine hydrochloride for injection (Drug)
The chemotherapy chosen by the investigator
The mono-chemotherapy drugs selected by the investigators included capecitabine, gemcitabine, vinorelbine, docetaxel, albumin-bound paclitaxel, or eribulin. The option should be determined before randomization.
干预措施: Vinorelbine tartrate injection (Drug)
The chemotherapy chosen by the investigator
The mono-chemotherapy drugs selected by the investigators included capecitabine, gemcitabine, vinorelbine, docetaxel, albumin-bound paclitaxel, or eribulin. The option should be determined before randomization.
干预措施: Paclitaxel for injection (albumin-bound type) (Drug)
The chemotherapy chosen by the investigator
The mono-chemotherapy drugs selected by the investigators included capecitabine, gemcitabine, vinorelbine, docetaxel, albumin-bound paclitaxel, or eribulin. The option should be determined before randomization.
干预措施: Docetaxel injection (Drug)
The chemotherapy chosen by the investigator
The mono-chemotherapy drugs selected by the investigators included capecitabine, gemcitabine, vinorelbine, docetaxel, albumin-bound paclitaxel, or eribulin. The option should be determined before randomization.
干预措施: Eribulin mesylate injection (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: up to approximately 3 years after the first enrollment
PFS evaluated by BICR according to RECIST v1.1 criteria is defined as the time from randomization to the first recorded disease progression or death from any cause as a result of BICR evaluation according to RECIST v1.1 criteria.
次要结局
- Overall survival（OS）(up to approximately 3 years after the first enrollment)
- Objective Response Rate (ORR)(up to approximately 3 years after the first enrollment)
- Duration of Response (DOR)(up to approximately 3 years after the first enrollment)