A Phase 3 Asian Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in Subjects With Hormonal Receptor-positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer (MBC) Who Have Failed at Least 2 Prior Chemotherapy Regimens
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 331
- 试验地点
- 43
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
The goal of this study is to compare the study drug, sacituzumab govitecan-hziy, versus doctors' treatment of choice in participants with HR+/HER2- metastatic breast cancer (MBC) who have failed at least 2 prior chemotherapy regimens.
详细描述
Approximately 330 eligible participants will be randomly allocated to one of the following 2 treatment arms in a 1:1 ratio:
Investigational Arm:
Sacituzumab Govitecan-hziy 10 mg/kg via intravenous (IV) injection administered on Day 1 and Day 8 (21-day cycle).
Control Arm:
Recommended doses and schedules as per package insert depending on region. Eribulin; Capecitabine; Gemcitabine; Vinorelbine Participants will be treated until disease progression as judged by local investigator review, development of unacceptable toxicity, or withdrawal of consent.
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
- •Female or male individuals aged ≥18 years at the time of signing the informed consent form
- •Documented evidence of hormone receptor-positive HER2-negative (HR+/HER2-) MBC confirmed
- •Refractory to or relapsed after at least 2, and no more than 4, prior systemic chemotherapy regimens for MBC
- •Should have been previously treated with at least 1 taxane in any setting, at least 1 prior anticancer hormonal treatment in any setting
- •Eligible for one of the chemotherapy options listed in the TPC arm
- •Documented radiographic disease progression after the most recent therapy
- •Measurable disease by CT or MRI in accordance with RECIST v 1.1, bone-only disease is not measurable and is not permitted.
- •Adequate bone marrow function, hepatic and renal function
- •Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative beta human chorionic gonadotropin [ß-hCG]
排除标准
- •Previous treatment with Topoisomerase 1 Inhibitors as a free form or as other formulations
- •Individuals who have known brain metastases.
- •Have an active second malignancy within 3 years prior to providing informed consent
- •Individuals with active hepatitis B virus (HBV), or hepatitis C virus infection (measurable viral RNA load with polymerase chain reaction).
- •Active serious infection requiring systemic antibiotic use within 7 days before Cycle1 Day
- •Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
- •Known hypersensitivity or intolerance to either of the study treatments or any of the excipients.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Sacituzumab Govitecan-hziy
Participants will receive Sacituzumab Govitecan-hziy 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)
Participants will receive recommended doses and schedules as per package insert depending on region.
- Eribulin (1.4 mg/m^2 of eribulin mesylate or 1.23 mg/m^2 of eribulin on Days 1 and 8 of a 21-day cycle)
- Capecitabine (1000 to 1250 mg/m^2 twice daily on Days 1 to 14 of a 21-day cycle)
- Gemcitabine (800 to 1200 mg/m^2 on Days 1, 8, and 15 of a 28-day cycle)
- Vinorelbine (25 mg/m^2 on Day 1 weekly)
干预措施: Eribulin Mesylate Injection (Drug)
Treatment of Physician's Choice (TPC)
Participants will receive recommended doses and schedules as per package insert depending on region.
- Eribulin (1.4 mg/m^2 of eribulin mesylate or 1.23 mg/m^2 of eribulin on Days 1 and 8 of a 21-day cycle)
- Capecitabine (1000 to 1250 mg/m^2 twice daily on Days 1 to 14 of a 21-day cycle)
- Gemcitabine (800 to 1200 mg/m^2 on Days 1, 8, and 15 of a 28-day cycle)
- Vinorelbine (25 mg/m^2 on Day 1 weekly)
干预措施: Capecitabine Oral Product (Drug)
Treatment of Physician's Choice (TPC)
Participants will receive recommended doses and schedules as per package insert depending on region.
- Eribulin (1.4 mg/m^2 of eribulin mesylate or 1.23 mg/m^2 of eribulin on Days 1 and 8 of a 21-day cycle)
- Capecitabine (1000 to 1250 mg/m^2 twice daily on Days 1 to 14 of a 21-day cycle)
- Gemcitabine (800 to 1200 mg/m^2 on Days 1, 8, and 15 of a 28-day cycle)
- Vinorelbine (25 mg/m^2 on Day 1 weekly)
干预措施: Gemcitabine Injection (Drug)
Treatment of Physician's Choice (TPC)
Participants will receive recommended doses and schedules as per package insert depending on region.
- Eribulin (1.4 mg/m^2 of eribulin mesylate or 1.23 mg/m^2 of eribulin on Days 1 and 8 of a 21-day cycle)
- Capecitabine (1000 to 1250 mg/m^2 twice daily on Days 1 to 14 of a 21-day cycle)
- Gemcitabine (800 to 1200 mg/m^2 on Days 1, 8, and 15 of a 28-day cycle)
- Vinorelbine (25 mg/m^2 on Day 1 weekly)
干预措施: Vinorelbine injection (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: Up to 4 years
PFS is defined as from the date of randomization until the date of disease progression (PD) or death, whichever occurs earlier. Disease progression will be determined according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1) by Independent Reviewing Committee (IRC).
次要结局
- Pharmacokinetic (PK) Parameter: Cmax of Sacituzumab Govitecan-hziy and Free SN-38(Up to 4 years)
- Overall Survival (OS)(Up to 4 years)
- Objective Response Rate (ORR) by IRC(Up to 4 years)
- Duration of Response (DOR) by IRC(Up to 4 years)
- Clinical Benefit Rate (CBR) by IRC(Up to 4 years)
- Change From Baseline of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core 30, Version 3.0 (EORTC QLQ-C30) Score(Baseline, up to 4 years)
- Percentage of Participants Experiencing Adverse Events (AEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0(First dose date up to 4 years plus 30 days)
- Percentage of Participants Experiencing Treatment-Emergent Adverse Events Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE)(Baseline, up to 4 years)
- PK Parameter: Tmax of of Sacituzumab Govitecan-hziy and Free SN-38(Up to 4 years)
- Change From Baseline of the European Quality of Life 5-Dimensions 5 Levels Instrument (EuroQOL EQ-5D-5L) Score(Baseline, up to 4 years)
- Percentage of Participants Experiencing Serious Adverse Events (SAEs) According to NCI CTCAE Version 5.0(First dose date up to 4 years plus 30 days)
- PK Parameter: Ctrough of Sacituzumab Govitecan-hziy and Free SN-38(Up to 4 years)