Asian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC)
- Conditions
- Metastatic Breast Cancer
- Interventions
- Registration Number
- NCT04639986
- Lead Sponsor
- Gilead Sciences
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 331
- 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]
Key
- 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 1.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment of Physician's Choice (TPC) Gemcitabine Injection 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) Treatment of Physician's Choice (TPC) Vinorelbine injection 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) Treatment of Physician's Choice (TPC) Eribulin Mesylate Injection 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) Treatment of Physician's Choice (TPC) Capecitabine Oral Product 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) Sacituzumab Govitecan-hziy Sacituzumab Govitecan-hziy Participants will receive Sacituzumab Govitecan-hziy 10 mg/kg on Days 1 and 8 of a 21-day cycle.
- Primary Outcome Measures
Name Time Method Progression-free Survival (PFS) Up to 3 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).
- Secondary Outcome Measures
Name Time Method Pharmacokinetic (PK) Parameter: Cmax of Sacituzumab Govitecan-hziy and Free SN-38 Up to 4 years Cmax is defined as the maximum observed concentration of drug.
Overall Survival (OS) Up to 4 years OS is defined as from the date of randomization to death from any cause.
Objective Response Rate (ORR) by IRC Up to 4 years ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR).
Duration of Response (DOR) by IRC Up to 4 years DOR is defined as from the date of first onset of tumor response (CR or PR) to PD or death, whichever occurs earlier.
Clinical Benefit Rate (CBR) by IRC Up to 4 years CBR is defined as best overall response of CR or PR or durable stable disease (SD) (duration of SD ≥ 6 months after randomization).
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 The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) to assess 15 scales; 1 global health status/quality of life (QOL), 5 functional scales (physical, role, cognitive, emotional, and social), and 9 symptom/item scales(fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of function, a high score for the global health status/QOL represents a high QOL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
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 NCI PRO-CTCAE is a patient-reported item library used to evaluate symptomatic treatment-emergent adverse events in participants on cancer clinical trials. The items selected for this study include: decreased appetite, nausea, vomiting, constipation, diarrhea, abdominal pain, shortness of breath, hair loss, and fatigue.
PK Parameter: Tmax of of Sacituzumab Govitecan-hziy and Free SN-38 Up to 4 years Tmax is defined as the time to maximum drug concentration.
Change From Baseline of the European Quality of Life 5-Dimensions 5 Levels Instrument (EuroQOL EQ-5D-5L) Score Baseline, up to 4 years The EQ-5D-5L is an instrument for use as a measure of health outcome.The EQ-5D-5L consists of 2 sections: the EuroQoL (5 dimensions) (EQ-5D) descriptive system and the EuroQoL visual analogue scale (EQ-VAS). The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Rating gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ-VAS indicate better health.
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 Ctrough is defined as the concentration of drug at the end of the dosing interval.
Trial Locations
- Locations (43)
Affiliated Tumor Hospital of Xinjiang Medical University
🇨🇳Ürümqi, China
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
China Medical University Hospital
🇨🇳Taichung, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Zhejiang Cancer Hospital
🇨🇳Hangzhou, China
Chinese PLA General Hospital
🇨🇳Beijing, China
Tri-Service General Hospital
🇨🇳Taipei, Taiwan
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Cancer Hospital Chinese Academy of Medical Science
🇨🇳Beijing, China
Jilin Cancer Hospital
🇨🇳Changchun, China
Peking University People's Hospital
🇨🇳Beijing, China
Chongqing University Cancer Hospital
🇨🇳Chengdu, China
The First Hospital of Jilin University
🇨🇳Changchun, China
West China Hospital, Sichuan University
🇨🇳Chengdu, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, China
Sun Yat Sen Memorial Hospital of Sun Yat sen University
🇨🇳Guangzhou, China
Sir Run run Shaw hospital Zhejiang University School of Medicine
🇨🇳Hangzhou, China
Anhui Provincial Hospital
🇨🇳Hefei, China
The second Hospital of Anhui Medical University
🇨🇳Hefei, China
Shandong Cancer Hospital
🇨🇳Jinan, China
Yunnan Cancer Hospital
🇨🇳Kunming, China
Linyi Cancer Hospital
🇨🇳Linyi, China
Nanjing Drum Tower Hospital
🇨🇳Nanjing, China
Shanghai General Hospital
🇨🇳Shanghai, China
Tianjin Medical University Cancer Institute & Hospital
🇨🇳Tianjin, China
Hubei Cancer Hospital
🇨🇳Wuhan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, China
Henan Cancer Hospital
🇨🇳Zhengzhou, China
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Changhua Christian Medical Foundation Changhua Christian Hospital
🇨🇳Changhua, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
Chang Gung Memorial Hospital, Linkou
🇨🇳Taoyuan, Taiwan
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Jiangsu Province Hospital
🇨🇳Nanjing, China