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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
331
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 is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.
Capecitabine is administered orally (PO) following recommended doses and regimens as per approved package inserts.
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).
Time frame: Up to 4 years
Overall Survival (OS)
OS is defined as from the date of randomization to death from any cause.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: First dose date up to 4 years plus 30 days
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Gemcitabine is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.
Vinorelbine is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.
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
...and 33 more locations
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 4 years