临床试验/NCT03901339

NCT03901339已完成3 期

Phase 3 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 (HER2) Negative Metastatic Breast Cancer (MBC) Who Have Failed at Least Two Prior Chemotherapy Regimens

Gilead Sciences113 个研究点分布在 1 个国家目标入组 543 人开始时间: 2019年5月8日最近更新: 2024年10月21日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Gilead Sciences
入组人数: 543
试验地点: 113
主要终点: Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) Assessment

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验相关资讯

研究概览

简要总结

The primary objective of this study is to assess and compare the efficacy and safety of sacituzumab govitecan-hzi versus treatment of physician's choice (TPC) in participants with hormonal receptor-positive (HR+) human epidermal growth factor receptor 2 (HER2-) negative metastatic breast cancer (MBC).

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

•Documented evidence of hormone receptor-positive human epidermal growth factor receptor 2 negative (HER2-negative) (hormonal receptor-positive (HR+)/HER2-) metastatic breast cancer (MBC) confirmed.
•Refractory to or relapsed after at least 2, and no more than 4, prior systemic chemotherapy regimens for metastatic disease:
•At least 1 taxane in any setting.
•At least 1 prior anticancer hormonal treatment in any setting.
•At least 1 cyclin-dependent kinase inhibitor 4/6 in any setting.
•Eligible for one of the chemotherapy options listed in the TPC arm.
•Documented disease progression after the most recent therapy.
•Adequate bone marrow function (hemoglobin ≥ 9 g/dL, absolute neutrophil count (ANC) ≥ 1,500 per mm^3, platelets ≥ 100,000 per mm^3).
•Adequate renal function: calculated creatinine clearance ≥ 30 mL/minute according to the Cockcroft and Gault formula .
•Adequate liver function (bilirubin ≤ 1.5 institutional upper limit of normal (IULN), or ≤ 3 IULN for individuals with documented Gilbert's syndrome, aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x IULN (in the case of liver metastases ≤ 5.0 x IULN)).
•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.
•History of significant cardiovascular disease or clinically significant electrocardiogram (ECG) abnormality.
•Active serious infection requiring antibiotics.
•Any medical or other condition which, in the opinion of the Investigator, causes the individual to be medically unfit to receive sacituzumab govitecan or unsuitable for any reason.
•Locally advanced MBC (stage IIIc) in individuals who are candidates for curative intent therapy at the time of study enrollment.
•Note: Other protocol defined Inclusion/Exclusion criteria may apply.

研究组 & 干预措施

Sacituzumab Govitecan-hziy

Experimental

Participants will receive sacituzumab govitecan-hziy 10 mg/kg via intravenous (IV) injection administered on Day 1 and Day 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 one of the following single-agent treatment:

Dosing per National Comprehensive Cancer Network (NCCN) guidelines (with dose modifications for if toxic)

Eribulin: 1.4 mg/m^2 for North American sites, 1.23 mg/m^2 for European sites) via IV on Days 1 and 8 of a 21-day cycle
Capecitabine: 1000-1250 mg/m^2 orally twice daily for 2 weeks followed by a 1-week rest period given as a 21-day cycle
Gemcitabine: 800-1200 mg/m^2 via IV on Days 1, 8, and 15 of each 28-day cycle or per institution
Vinorelbine: 25 mg/m^2 via IV on Day 1 weekly cycle per institution

干预措施: Eribulin (Drug)

Treatment of Physician's Choice (TPC)

Active Comparator

Participants will receive TPC determined prior to randomization from one of the following single-agent treatment:

Dosing per National Comprehensive Cancer Network (NCCN) guidelines (with dose modifications for if toxic)

Eribulin: 1.4 mg/m^2 for North American sites, 1.23 mg/m^2 for European sites) via IV on Days 1 and 8 of a 21-day cycle
Capecitabine: 1000-1250 mg/m^2 orally twice daily for 2 weeks followed by a 1-week rest period given as a 21-day cycle
Gemcitabine: 800-1200 mg/m^2 via IV on Days 1, 8, and 15 of each 28-day cycle or per institution
Vinorelbine: 25 mg/m^2 via IV on Day 1 weekly cycle per institution

干预措施: Capecitabine (Drug)

Treatment of Physician's Choice (TPC)

Active Comparator

Participants will receive TPC determined prior to randomization from one of the following single-agent treatment:

Dosing per National Comprehensive Cancer Network (NCCN) guidelines (with dose modifications for if toxic)

Eribulin: 1.4 mg/m^2 for North American sites, 1.23 mg/m^2 for European sites) via IV on Days 1 and 8 of a 21-day cycle
Capecitabine: 1000-1250 mg/m^2 orally twice daily for 2 weeks followed by a 1-week rest period given as a 21-day cycle
Gemcitabine: 800-1200 mg/m^2 via IV on Days 1, 8, and 15 of each 28-day cycle or per institution
Vinorelbine: 25 mg/m^2 via IV on Day 1 weekly cycle per institution

干预措施: Gemcitabine (Drug)

Treatment of Physician's Choice (TPC)

Active Comparator

Participants will receive TPC determined prior to randomization from one of the following single-agent treatment:

Dosing per National Comprehensive Cancer Network (NCCN) guidelines (with dose modifications for if toxic)

Eribulin: 1.4 mg/m^2 for North American sites, 1.23 mg/m^2 for European sites) via IV on Days 1 and 8 of a 21-day cycle
Capecitabine: 1000-1250 mg/m^2 orally twice daily for 2 weeks followed by a 1-week rest period given as a 21-day cycle
Gemcitabine: 800-1200 mg/m^2 via IV on Days 1, 8, and 15 of each 28-day cycle or per institution
Vinorelbine: 25 mg/m^2 via IV on Day 1 weekly cycle per institution

干预措施: Vinorelbine (Drug)

结局指标

主要结局

Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) Assessment

时间窗: Up to 42.8 months

PFS was defined as the time from the date of randomization to the date of the first documentation of disease progression or death (whichever occurred first) according to BICR using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Disease progression was defined as an increase of greater than 20% in the sum of the longest diameter (LD) of target lesions and a 5 mm absolute increase, taking as a reference the smallest sum LD recorded since the baseline assessment or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate.

次要结局

Overall Survival (OS)(Up to 42.8 months)
Objective Response Rate (ORR) by BICR and Local Investigator Review (LIR) Assessment(Up to 42.8 months)
Duration of Response (DOR) by BICR and LIR Assessment(Up to 42.8 months)
Clinical Benefit Rate (CBR) by BICR and LIR Assessment(Up to 42.8 months)
PFS by LIR Assessment(Up to 42.8 months)
Time to Deterioration (TTD) of Global Health Status/Quality of Life (QoL) Scale as Measured by European Organization for Research and Treatment of Cancer Quality of Life for Cancer Patients, Core Questionnaire Version 3.0 (EORTC QLQ-C30)(Up to 37.8 months)
TTD of Pain Score as Measured by EORTC QLQ-C30(Up to 37.8 months)
TTD of Fatigue Score as Measured by EORTC QLQ-C30(Up to 37.8 months)
Percentage of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs)(Up to 43.4 months)
Percentage of Participants Who Experienced Treatment Emergent Serious Adverse Events (TESAEs)(Up to 43.4 months)
Percentage of Participants Who Experienced the Worst Laboratory Abnormalities Grade 3 or 4 Post-Baseline(Up to 43.4 months)
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) - Shift From Baseline Value to Best Value During Treatment(Up to 43.4 months)

研究者

发起方

Gilead Sciences

申办方类型

Industry

责任方

Sponsor

研究点 (113)

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