NCT07540533招募中2 期
A Multicohort Study of Toripalimab in Combination With Investigator-Selected Chemotherapy for Advanced HER2-Negative Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- ORR by investigator
研究概览
简要总结
To evaluate the efficacy and safety of toripalimab in combination with investigator-selected chemotherapy in patients with recurrent or metastatic HER2-negative breast cancer who have failed prior systemic therapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary participation: the subject must give written informed consent, be compliant, and agree to attend all follow-up visits.
- •Age ≥ 18 years.
- •ECOG performance-status score ≤ 1 and life expectancy ≥ 3 months.
- •Histologically or cytologically confirmed HER2-negative breast cancer (HER2-negative is defined as either IHC 0, IHC 1+, or IHC 2+ with a negative in-situ-hybridisation [ISH] result).
- •For subjects with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC):
- •- Must have experienced progression during/after at least one prior systemic regimen for recurrent/metastatic disease (recurrence ≤ 12 months after neoadjuvant/adjuvant therapy counts as first-line failure).
- •- Cohort assignment by prior immune-checkpoint-inhibitor (ICI) exposure:
- •Cohort A - ICI-pretreated:
- •If ICI was given in adjuvant setting, recurrence must occur ≥ 12 months after completion of immunotherapy.
- •If ICI was given in neoadjuvant or metastatic setting, best overall response must have met clinical-benefit criteria (PR, CR, or SD > 24 weeks).
- •Cohort B - ICI-naïve: no prior anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or any other antibody targeting T-cell co-stimulatory or checkpoint pathways.
- •For subjects with hormone-receptor-positive (HR+) breast cancer:
- •Must have progressed after ≥ 2 prior endocrine regimens in the recurrent/metastatic setting (unless investigator judges no endocrine benefit), and
- •Must have progressed after ≥ 1 prior systemic chemotherapy for recurrent/metastatic disease (recurrence ≤ 12 months after adjuvant/neoadjuvant therapy counts as first-line failure).
- •At least one measurable lesion per RECIST v1.
- •Adequate organ function, defined as:
- •Haematology (no transfusion within 14 days):
- •Haemoglobin ≥ 9 g/dL
- •Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L
- •Platelet count ≥ 100 × 10⁹/L . Serum chemistry:
- •Total bilirubin ≤ 1.5 × ULN, or if total bilirubin > ULN then direct bilirubin ≤ ULN
- •ALT and AST ≤ 2.5 × ULN
- •Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL/min
- •Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test within 7 days before first dose and must use highly effective contraception from first dose until 6 months after last dose.
- •WOCBP is defined as any sexually mature female who has not undergone hysterectomy or bilateral oophorectomy and who has not experienced natural amenorrhoea for ≥ 24 consecutive months (including women with treatment-induced amenorrhoea).Men whose partners are WOCBP must also use effective contraception during the same period.
排除标准
- •Uncontrolled central-nervous-system metastases (symptomatic or requiring corticosteroids or mannitol for symptom control).
- •Clinically significant or uncontrolled cardiac disease within 6 months before first dose, including congestive heart failure, angina, myocardial infarction, or ventricular arrhythmia.
- •Malignancy within 5 years before first dose, except adequately treated basal-cell carcinoma of the skin or carcinoma in situ of the cervix.
- •Active autoimmune disease requiring systemic therapy within 2 years before first dose, except vitiligo, type-1 diabetes, or residual hypothyroidism due to autoimmune thyroiditis managed with hormone replacement only.
- •Uncontrolled pleural, pericardial, or ascitic fluid requiring repeated drainage.
- •Documented human immunodeficiency virus (HIV) infection.
- •Documented hepatitis-B infection or active hepatitis-C infection.
- •Prior hypersensitivity to any component or excipient of the investigational product(s).
- •Any condition judged by the investigator to render the patient unsuitable for trial participation.
研究组 & 干预措施
Cohort A
Experimental
Cohort A: triple-negative breast cancer (TNBC) previously treated with immune-checkpoint inhibitors (ICI);
干预措施: TPC (Drug)
Cohort B
Experimental
Cohort B: TNBC without prior ICI exposure;
干预措施: TPC (Drug)
Cohort C
Experimental
Cohort C: HR-positive/HER2-negative breast cancer.
干预措施: TPC (Drug)
Cohort B
Experimental
Cohort B: TNBC without prior ICI exposure;
干预措施: Toripalimab (Drug)
Cohort C
Experimental
Cohort C: HR-positive/HER2-negative breast cancer.
干预措施: Toripalimab (Drug)
Cohort A
Experimental
Cohort A: triple-negative breast cancer (TNBC) previously treated with immune-checkpoint inhibitors (ICI);
干预措施: Toripalimab (Drug)
结局指标
主要结局
ORR by investigator
时间窗: At baseline, at the time point of every 8 weeks within first 24 weeks, thereafter every 12 weeks
ORR is the percentage of evaluable patients with a confirmed investigator-assessed response of CR (complete response) or PR (partial response) per RECIST v1.1.
次要结局
- PFS(up to 3 years)
- DCR(At baseline, at the time point of every 8 weeks within first 24 weeks, thereafter every 12 weeks)
- DoR(up to 3 years)
- OS(up to 3 years)
- Safety (Proportion of AEs)(from time of informed consent provided to 30 days after the last dose of study therapy)
研究者
Min Yan, MD
Chief physician
Henan Cancer Hospital
研究点 (1)
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