Back to resultsAsian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC)
Primary Purpose
Metastatic Breast Cancer
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Sacituzumab Govitecan-hziy
Eribulin Mesylate Injection
Capecitabine Oral Product
Gemcitabine Injection
Vinorelbine injection
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring sacituzumab govitecan, IMMU-132, Unresectable or Metastatic Breast Cancer, hormonal receptor, HR positive, Anti-TROP2, Human epidermal growth factor receptor 2 (HER2) Negative, Antibody Drug Conjugate
Eligibility Criteria
Inclusion Criteria:
- Female or male subjects 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]
Exclusion Criteria:
- Previous treatment with Topoisomerase 1 Inhibitors as a free form or as other formulations
- Subjects who have known brain metastases.
- Have an active second malignancy within 3 years prior to providing informed consent
- Subjects 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 C1D1.
- Patients with a history of an anaphylactic reaction to irinotecan.
- 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.
Sites / Locations
- Cancer Hospital Chinese Academy of Medical Science
- Chinese PLA General Hospital
- Peking University People's Hospital
- Jilin Cancer Hospital
- The First Hospital of Jilin University
- Chongqing University Cancer Hospital
- West China Hospital, Sichuan University
- Fujian Medical University Union Hospital
- Guangdong Provincial People's Hospital
- Sun Yat Sen Memorial Hospital of Sun Yat sen University
- Sun Yat-sen University Cancer Center
- Sir Run run Shaw hospital Zhejiang University School of Medicine
- Zhejiang Cancer Hospital
- Anhui Provincial Hospital
- The second Hospital of Anhui Medical University
- Shandong Cancer Hospital
- Yunnan Cancer Hospital
- Linyi Cancer Hospital
- Jiangsu Province Hospital
- Nanjing Drum Tower Hospital
- Shanghai General Hospital
- Tianjin Medical University Cancer Institute & Hospital
- Hubei Cancer Hospital
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- The First Affiliated Hospital of Xi'an Jiaotong University
- Henan Cancer Hospital
- Affiliated Tumor Hospital of Xinjiang Medical University
- Dong-A University Hospital
- Seoul National University Bundang Hospital
- Asan Medical Center
- Korea University Anam Hospital
- Samsung Medical Center
- Seoul National University Hospital
- Severance Hospital Yonsei University Health System
- Ajou University Hospital
- Changhua Christian Medical Foundation Changhua Christian Hospital
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- China Medical University Hospital
- National Cheng Kung University Hospital
- National Taiwan University Hospital
- Taipei Veterans General Hospital
- Tri-Service General Hospital
- Chang Gung Memorial Hospital, Linkou
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sacituzumab Govitecan-hziy
Treatment of Physician's Choice (TPC)
Arm Description
Participants will receive Sacituzumab Govitecan-hziy 10 mg/kg on Days 1 and 8 of a 21-day cycle.
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)
Outcomes
Primary Outcome Measures
Progression-free Survival (PFS)
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
Overall Survival (OS)
OS is defined as from the date of randomization to death from any cause.
Objective Response Rate (ORR) by IRC
ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR).
Duration of Response (DOR) by IRC
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
CBR is defined as best overall response of CR or PR or durable stable disease (SD) (duration of SD ≥ 6 months after randomization).
Percentage of Participants Experiencing Adverse Events (AEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Percentage of Participants Experiencing Serious Adverse Events (SAEs) According to NCI CTCAE Version 5.0
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
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.
Change From Baseline of the European Quality of Life 5-Dimensions 5 Levels Instrument (EuroQOL EQ-5D-5L) Score
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 Treatment-Emergent Adverse Events Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE)
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.
Pharmacokinetic (PK) Parameter: Cmax of Sacituzumab Govitecan-hziy and Free SN-38
Cmax is defined as the maximum observed concentration of drug.
PK Parameter: Tmax of of Sacituzumab Govitecan-hziy and Free SN-38
Tmax is defined as the time to maximum drug concentration.
PK Parameter: Ctrough of Sacituzumab Govitecan-hziy and Free SN-38
Ctrough is defined as the concentration of drug at the end of the dosing interval.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04639986
Brief Title
Asian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 23, 2020 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
Keywords
sacituzumab govitecan, IMMU-132, Unresectable or Metastatic Breast Cancer, hormonal receptor, HR positive, Anti-TROP2, Human epidermal growth factor receptor 2 (HER2) Negative, Antibody Drug Conjugate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
331 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sacituzumab Govitecan-hziy
Arm Type
Experimental
Arm Description
Participants will receive Sacituzumab Govitecan-hziy 10 mg/kg on Days 1 and 8 of a 21-day cycle.
Arm Title
Treatment of Physician's Choice (TPC)
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Sacituzumab Govitecan-hziy
Other Intervention Name(s)
IMMU-132, Trodelvy™, GS-0132
Intervention Description
Sacituzumab govitecan 10 mg/kg via IV injection administered on Days 1 and 8 of a 21-day cycle. Subjects will continue to receive study treatment until PD as judged by local investigator review, development of unacceptable toxicity, or withdrawal of consent.
Intervention Type
Drug
Intervention Name(s)
Eribulin Mesylate Injection
Other Intervention Name(s)
Halaven
Intervention Description
Eribulin is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.
Intervention Type
Drug
Intervention Name(s)
Capecitabine Oral Product
Other Intervention Name(s)
Xeloda
Intervention Description
Capecitabine is administered orally (PO) following recommended doses and regimens as per approved package inserts.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine Injection
Other Intervention Name(s)
Gemzar
Intervention Description
Gemcitabine is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.
Intervention Type
Drug
Intervention Name(s)
Vinorelbine injection
Other Intervention Name(s)
Navelbine
Intervention Description
Vinorelbine is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
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).
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is defined as from the date of randomization to death from any cause.
Time Frame
Up to 4 years
Title
Objective Response Rate (ORR) by IRC
Description
ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR).
Time Frame
Up to 4 years
Title
Duration of Response (DOR) by IRC
Description
DOR is defined as from the date of first onset of tumor response (CR or PR) to PD or death, whichever occurs earlier.
Time Frame
Up to 4 years
Title
Clinical Benefit Rate (CBR) by IRC
Description
CBR is defined as best overall response of CR or PR or durable stable disease (SD) (duration of SD ≥ 6 months after randomization).
Time Frame
Up to 4 years
Title
Percentage of Participants Experiencing Adverse Events (AEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Time Frame
First dose date up to 4 years plus 30 days
Title
Percentage of Participants Experiencing Serious Adverse Events (SAEs) According to NCI CTCAE Version 5.0
Time Frame
First dose date up to 4 years plus 30 days
Title
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
Description
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.
Time Frame
Baseline, up to 4 years
Title
Change From Baseline of the European Quality of Life 5-Dimensions 5 Levels Instrument (EuroQOL EQ-5D-5L) Score
Description
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.
Time Frame
Baseline, up to 4 years
Title
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)
Description
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.
Time Frame
Baseline, up to 4 years
Title
Pharmacokinetic (PK) Parameter: Cmax of Sacituzumab Govitecan-hziy and Free SN-38
Description
Cmax is defined as the maximum observed concentration of drug.
Time Frame
Up to 4 years
Title
PK Parameter: Tmax of of Sacituzumab Govitecan-hziy and Free SN-38
Description
Tmax is defined as the time to maximum drug concentration.
Time Frame
Up to 4 years
Title
PK Parameter: Ctrough of Sacituzumab Govitecan-hziy and Free SN-38
Description
Ctrough is defined as the concentration of drug at the end of the dosing interval.
Time Frame
Up to 4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
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 Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Cancer Hospital Chinese Academy of Medical Science
City
Beijing
Country
China
Facility Name
Chinese PLA General Hospital
City
Beijing
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
Country
China
Facility Name
Jilin Cancer Hospital
City
Changchun
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
Country
China
Facility Name
Chongqing University Cancer Hospital
City
Chengdu
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
Country
China
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
Country
China
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
Country
China
Facility Name
Sun Yat Sen Memorial Hospital of Sun Yat sen University
City
Guangzhou
Country
China
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
Country
China
Facility Name
Sir Run run Shaw hospital Zhejiang University School of Medicine
City
Hangzhou
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
Country
China
Facility Name
Anhui Provincial Hospital
City
Hefei
Country
China
Facility Name
The second Hospital of Anhui Medical University
City
Hefei
Country
China
Facility Name
Shandong Cancer Hospital
City
Jinan
Country
China
Facility Name
Yunnan Cancer Hospital
City
Kunming
Country
China
Facility Name
Linyi Cancer Hospital
City
Linyi
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
Country
China
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
Country
China
Facility Name
Shanghai General Hospital
City
Shanghai
Country
China
Facility Name
Tianjin Medical University Cancer Institute & Hospital
City
Tianjin
Country
China
Facility Name
Hubei Cancer Hospital
City
Wuhan
Country
China
Facility Name
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
Country
China
Facility Name
Affiliated Tumor Hospital of Xinjiang Medical University
City
Ürümqi
Country
China
Facility Name
Dong-A University Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital Yonsei University Health System
City
Seoul
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon
Country
Korea, Republic of
Facility Name
Changhua Christian Medical Foundation Changhua Christian Hospital
City
Changhua
Country
Taiwan
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Taipei
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital, Linkou
City
Taoyuan
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35728046
Citation
Kwapisz D. Sacituzumab Govitecan-hziy in Breast Cancer. Am J Clin Oncol. 2022 Jul 1;45(7):279-285. doi: 10.1097/COC.0000000000000919. Epub 2022 May 12.
Results Reference
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Asian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC)
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