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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20210096 | Registry Identifier | China: Drug Clinical Trial Registration and Information Disclosure Platform |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sacituzumab Govitecan-hziy | Experimental | Participants will receive Sacituzumab Govitecan-hziy 10 mg/kg on Days 1 and 8 of a 21-day cycle. |
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| Treatment of Physician's Choice (TPC) | Active Comparator | Participants will receive recommended doses and schedules as per package insert depending on region.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sacituzumab Govitecan-hziy | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as from the date of randomization to death from any cause. | Up to 4 years |
| Objective Response Rate (ORR) by IRC | ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR). |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Science | Beijing | China | ||||
| Chinese PLA General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39354196 | Derived | Xu B, Wang S, Yan M, Sohn J, Li W, Tang J, Wang X, Wang Y, Im SA, Jiang D, Valdez T, Dasgupta A, Zhang Y, Yan Y, Komatsubara KM, Chung WP, Ma F, Dai MS. Sacituzumab govitecan in HR+HER2- metastatic breast cancer: the randomized phase 3 EVER-132-002 trial. Nat Med. 2024 Dec;30(12):3709-3716. doi: 10.1038/s41591-024-03269-z. Epub 2024 Oct 1. | |
| 35728046 |
| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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| Eribulin Mesylate Injection | Drug | Eribulin is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts. |
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| Capecitabine Oral Product | Drug | Capecitabine is administered orally (PO) following recommended doses and regimens as per approved package inserts. |
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| Gemcitabine Injection | Drug | Gemcitabine is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts. |
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| Vinorelbine injection | Drug | Vinorelbine is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts. |
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| Up to 4 years |
| 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 |
| 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 |
| 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 Serious Adverse Events (SAEs) According to NCI CTCAE Version 5.0 | First dose date up to 4 years plus 30 days |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 | China |
| Dong-A University Hospital | Busan | South Korea |
| Seoul National University Bundang Hospital | Seongnam | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Korea University Anam Hospital | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Severance Hospital Yonsei University Health System | Seoul | South Korea |
| Ajou University Hospital | Suwon | South Korea |
| Changhua Christian Medical Foundation Changhua Christian Hospital | Changhua | Taiwan |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | 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 | Taiwan |
| 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. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000608132 | sacituzumab govitecan |
| C490954 | eribulin |
| D000069287 | Capecitabine |
| D000093542 | Gemcitabine |
| D000077235 | Vinorelbine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
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