The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to currently available standard treatments, such as paclitaxel, nab-paclitaxel or capecitabine. The primary objective is to compare the effect of SG relative to the treatment of physician's choice (TPC) on progression-free survival (PFS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
654
Administered intravenously
Administered intravenously
Administered intravenously
Administered orally
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Chandler, Arizona, United States
Los Angeles Hematology Oncology Medical Group
Los Angeles, California, United States
Stanford Cancer Institute
Palo Alto, California, United States
University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Rocky Mountain Cancer Centers, LLP
Littleton, Colorado, United States
Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
PFS is defined as time from date of randomization until the date of first objective progressive disease (PD) or death from any cause, whichever comes first.
Time frame: Up to approximately 29 months
Overall Survival (OS)
OS is defined as the time from randomization until the date of death from any cause.
Time frame: Until death, up to approximately 60 months
Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1
ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response.
Time frame: Until progression, up to approximately 60 months
Change from Baseline in the Physical Functioning Domain Using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) at Week 16
The EORTC QLQ-C30 is composed of global health status/QoL scale; five functional domains (physical, role, emotional, cognitive, and social); three symptom domains (fatigue, nausea and vomiting, and pain); and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The Physical Functioning domain includes 5 questions in which participants will be asked to rate their overall health and overall quality of life as it relates to physical functioning during the past week on a scale from 1 (very poor) to 4 (excellent), with a higher score representing a high QoL.
Time frame: Baseline, Week 16
Time to Deterioration in Version 3.0 EORTC-QLQ-C30 Scores
Time to deterioration from baseline in European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores. Scale scores range from 0-100. For functioning and global health status/QoL scales, higher scores indicate better functioning or global health status/QoL. For symptom scales, higher scores indicate greater symptom burden.
Time frame: Up to approximately 60 months
Progression Free Survival (PFS) as Assessed by Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
PFS is defined as time from date of randomization until the date of first objective progressive disease (PD) by investigator assessment according to RECIST v1.1 or death from any cause, whichever comes first.
Time frame: Until progression or death, up to approximately 60 months
Objective Response Rate (ORR) as Assessed by Investigator per RECIST Version 1.1
ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response.
Time frame: Up to approximately 60 months
Duration of Response (DOR) as Assessed by BICR and Investigator per RECIST Version 1.1
DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of objective PD or death from any cause (whichever comes first).
Time frame: Until progression or death, up to approximately 60 months
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: First dose date up to 30 days post last dose, up to approximately 60 months
Percentage of Participants Experiencing Clinically Significant Laboratory and/or Vital Sign Abnormalities
Time frame: First dose date up to 30 days post last dose, up to approximately 60 months
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Yale-New Haven Hospital-Yale Cancer Center
New Haven, Connecticut, United States
Investigational Drug Services, AdventHealth Orlando
Altamonte Springs, Florida, United States
Florida Cancer Specialists
Brooksville, Florida, United States
Florida Cancer Specialist
Leesburg, Florida, United States
Florida Cancer Specialist
St. Petersburg, Florida, United States
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