jRCT2031250059尚未招募不适用
A Phase 3, Randomized, Open-label Study Comparing Efficacy and Safety of Sacituzumab Tirumotecan (sac-TMT, MK-2870) as a Monotherapy and in Combination with Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With Previously Untreated Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Expressing PD-L1 at CPS Less than 10 (TroFuse-011)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- MSD K.K.
- 入组人数
- 53
- 主要终点
- progression-free survival (PFS)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Has locally recurrent unresectable or metastatic TNBC that cannot be treated with curative intent
- •Has not received systemic treatment for locally recurrent unresectable or metastatic TNBC
- •Participants previously treated for early-stage breast cancer must have completed all prior therapy for early-stage breast cancer with curative intent at least 6 months before the first disease recurrence
- •Is a candidate for treatment with one of the TPC options: paclitaxel or nab-paclitaxel or gemcitabine + carboplatin
- •Participants who have AEs due to previous anticancer therapies must have recovered to <=Grade 1 or baseline with the exception of alopecia or vitiligo. Participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible
- •Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
- •Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
排除标准
- •Has breast cancer amenable to treatment with curative intent
- •Has TNBC with evaluable tumor programmed death ligand 1 (PD-L1) expression at combined positive score (CPS) >=10
- •Has received prior systemic therapy for treatment of locally recurrent unresectable or metastatic TNBC
- •Has Grade >=2 peripheral neuropathy
- •Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing
- •Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
- •Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
- •Has skin only metastatic disease
- •Has advanced/metastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications
- •Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- •Has known additional malignancy that is progressing or has required active treatment within the past 5 years
- •Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable
- •Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
- •History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- •Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV deoxyribonucleic acid (DNA)) and Hepatitis C virus (HCV) (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection
- •History of stem cell/solid organ transplant
- •Has not adequately recovered from major surgery or has ongoing surgical complications
结局指标
主要结局
progression-free survival (PFS)
To compare MK-2870 plus MK-3475 to TPC with respect to PFS
overall survival (OS)
To compare MK-2870 to TPC with respect to overall survival (OS)
次要结局
- OS
- PFS
- ORR
- duration of response
- health-related quality of life
- safety and tolerability
研究者
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