NCT05382299进行中（未招募）3 期
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 623
- 试验地点
- 712
- 主要终点
- Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
研究概览
简要总结
The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) versus treatment of physician's choice (TPC) in participants with previously untreated, locally advanced, inoperable or metastatic triple-negative breast cancer whose tumors do not express programmed cell death ligand 1 (PD-L1) or in participants previously treated with anti-programmed cell death (ligand or protein) 1 (Anti-PD-(L)1) Agents in the early setting whose tumors do express PD-L1.
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
- •Individuals, regardless of race and ethnic group, with previously untreated locally advanced, inoperable or metastatic triple-negative breast cancer (TNBC)
- •Individuals whose tumors are programmed cell death ligand 1 (PD-L1) negative at screening or individuals whose tumors are PD-L1 positive at screening if they have received an anti-PD-(L)1 inhibitor in the (neo) adjuvant setting or if they cannot be treated with a checkpoint inhibitor due to a comorbidity
- •Centrally confirmed TNBC and PD-L1 status on fresh or archival tissue
- •Individuals must have completed treatment for Stage I-III breast cancer, if indicated, and ≥ 6 months must have elapsed (with the exception of endocrine therapy) between completion of treatment with curative intent and first documented local or distant disease recurrence
- •Individuals presenting with de novo metastatic TNBC are eligible
- •Measurable disease based on computed tomography (CT) or magnetic resonance imaging (MRI) in accordance with per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.
- •as evaluated locally
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Demonstrates adequate organ function
- •Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception
- •Individuals with human immunodeficiency virus (HIV) must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease
排除标准
- •Positive serum pregnancy test or women who are lactating
- •Received systemic anticancer treatment within the previous 6 months or radiation therapy within 2 weeks prior to enrollment
- •Have not recovered from adverse events (AEs) due to a previously administered agent at the time study entry
- •May not be participating in a study with an investigational agent or investigational device within 4 weeks prior to randomization. Individuals participating in observational studies are eligible
- •Previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor
- •Active second malignancy
- •Active serious infection requiring antibiotics
- •Positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease
- •Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Sacituzumab Govitecan-hziy (SG)
Experimental
Participants will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle.
干预措施: Sacituzumab Govitecan-hziy (Drug)
Treatment of Physician's Choice (TPC)
Active Comparator
Participants will receive TPC determined prior to randomization from 1 of the 3 allowed regimens:
- Paclitaxel 90 mg/m^2 on Days 1, 8, and 15 of a 28-day cycle
- Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of a 28-day cycle
- Gemcitabine 1000 mg/m^2 + carboplatin area under the curve (AUC) 2 on Days 1 and 8 of a 21-day cycle
干预措施: nab-Paclitaxel (Drug)
Treatment of Physician's Choice (TPC)
Active Comparator
Participants will receive TPC determined prior to randomization from 1 of the 3 allowed regimens:
- Paclitaxel 90 mg/m^2 on Days 1, 8, and 15 of a 28-day cycle
- Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of a 28-day cycle
- Gemcitabine 1000 mg/m^2 + carboplatin area under the curve (AUC) 2 on Days 1 and 8 of a 21-day cycle
干预措施: Carboplatin (Drug)
Treatment of Physician's Choice (TPC)
Active Comparator
Participants will receive TPC determined prior to randomization from 1 of the 3 allowed regimens:
- Paclitaxel 90 mg/m^2 on Days 1, 8, and 15 of a 28-day cycle
- Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of a 28-day cycle
- Gemcitabine 1000 mg/m^2 + carboplatin area under the curve (AUC) 2 on Days 1 and 8 of a 21-day cycle
干预措施: Paclitaxel (Drug)
Treatment of Physician's Choice (TPC)
Active Comparator
Participants will receive TPC determined prior to randomization from 1 of the 3 allowed regimens:
- Paclitaxel 90 mg/m^2 on Days 1, 8, and 15 of a 28-day cycle
- Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of a 28-day cycle
- Gemcitabine 1000 mg/m^2 + carboplatin area under the curve (AUC) 2 on Days 1 and 8 of a 21-day cycle
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
时间窗: Randomization up to approximately 57 months
PFS is defined as the time from the date of randomization until the date of objective progressive disease (PD), or death (whichever comes first).
次要结局
- Duration of Response (DOR) as Assessed by BICR per RECIST Version 1.1(Randomization up to approximately 57 months)
- Overall Survival (OS)(Randomization up to approximately 57 months)
- Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1(Randomization up to approximately 57 months)
- Time to Response (TTR) as Assessed by BICR per RECIST Version 1.1(Randomization up to approximately 57 months)
- Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)(First dose date up to approximately 57 months plus 30 days)
- Time to Deterioration (TTD) of Fatigue Scale of the EORTC QLQ-C30(Randomization up to approximately 57 months)
- Percentage of Participants Experiencing Clinical Laboratory Abnormalities(First dose date up to approximately 57 months plus 30 days)
- Change from Baseline in the Physical Functioning Domain as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core Questionnaire, Version 3.0 (EORTC QLQ-C30).(Randomization up to approximately 57 months)
研究者
研究点 (712)
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