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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
First received
Last updated
Start date November 23, 2020
Est. completion date December 2025

Study information

Verified date June 2024
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority
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 December 2025
Est. primary completion date December 2025
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.

Study Design


Related Conditions & MeSH terms


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
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