Asian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC)

Metastatic Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04639986
• Other study ID #: EVER-132-002
• Secondary ID: CTR20210096
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 23, 2020
• Est. completion date: March 2024

Study information

• Verified date: October 2023
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 331
• Est. completion date: March 2024
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Sacituzumab Govitecan-hziy
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.
• Eribulin Mesylate Injection
Eribulin is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.
• Capecitabine Oral Product
Capecitabine is administered orally (PO) following recommended doses and regimens as per approved package inserts.
• Gemcitabine Injection
Gemcitabine is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.
• Vinorelbine injection
Vinorelbine is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Science	Beijing
China	Chinese PLA General Hospital	Beijing
China	Peking University People's Hospital	Beijing
China	Jilin Cancer Hospital	Changchun
China	The First Hospital of Jilin University	Changchun
China	Chongqing University Cancer Hospital	Chengdu
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 Memorial Hospital of Sun Yat sen University	Guangzhou
China	Sun Yat-sen University Cancer Center	Guangzhou
China	Sir Run run Shaw hospital Zhejiang University School of Medicine	Hangzhou
China	Zhejiang Cancer Hospital	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	Jiangsu Province Hospital	Nanjing
China	Nanjing Drum Tower Hospital	Nanjing
China	Shanghai General Hospital	Shanghai
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin
China	Affiliated Tumor Hospital of Xinjiang Medical University	Ürümqi
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
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital Yonsei University Health System	Seoul
Korea, Republic of	Ajou University Hospital	Suwon
Taiwan	Changhua Christian Medical Foundation Changhua Christian Hospital	Changhua
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	China Medical University Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei
Taiwan	Chang Gung Memorial Hospital, Linkou	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

China,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Up to 3 years
Secondary	Overall Survival (OS)	OS is defined as from the date of randomization to death from any cause.	Up to 4 years
Secondary	Objective Response Rate (ORR) by IRC	ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR).	Up to 4 years
Secondary	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.	Up to 4 years
Secondary	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).	Up to 4 years
Secondary	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
Secondary	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
Secondary	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.	Baseline, up to 4 years
Secondary	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.	Baseline, up to 4 years
Secondary	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.	Baseline, up to 4 years
Secondary	Pharmacokinetic (PK) Parameter: Cmax of Sacituzumab Govitecan-hziy and Free SN-38	Cmax is defined as the maximum observed concentration of drug.	Up to 4 years
Secondary	PK Parameter: Tmax of of Sacituzumab Govitecan-hziy and Free SN-38	Tmax is defined as the time to maximum drug concentration.	Up to 4 years
Secondary	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.	Up to 4 years