Sacituzumab Govitecan-hziy
DrugAdministered intravenously
Other names: Trodelvy™, GS-0132, IMMU-132
NCT Number: NCT05840211
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).
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 3
Hospital Britanico de Buenos Aires, Buenos Aires, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Administered intravenously
Other names: Trodelvy™, GS-0132, IMMU-132
Administered intravenously
Other names: Taxol®
Administered intravenously
Other names: Abraxane®
Administered orally
Other names: Xeloda®
Time frame: Up to approximately 29 months
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: Until death, up to approximately 60 months
OS is defined as the time from randomization until the date of death from any cause.
Time frame: Until progression, up to approximately 60 months
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: Baseline, 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: Up to approximately 60 months
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: Until progression or death, up to approximately 60 months
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: Up to approximately 60 months
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 or death, up to approximately 60 months
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: First dose date up to 30 days post last dose, up to approximately 60 months
Time frame: First dose date up to 30 days post last dose, up to approximately 60 months
Gilead Sciences
Industry
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH-]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy
Acronym: ASCENT-07
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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