Sacituzumab Govitecan-hziy (SG)
DrugAdministered intravenously
Other names: GS-0132, IMMU-132, Trodelvy™
NCT Number: NCT05633654
The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative breast cancer that still remains after surgery and pre-surgical treatment.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
Macarthur Cancer Therapy Centre, Campbelltown Hospital, Campbelltown, New South Wales, Australia
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: GS-0132, IMMU-132, Trodelvy™
Administered intravenously
Other names: KEYTRUDA®
Tablets administered orally
Other names: Xeloda
Time frame: Up to 60 months
iDFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): invasive local, regional, or distant recurrence, invasive contralateral breast cancer.
Time frame: Up to 96 months
OS is defined as the time from the date of randomization until death due to any cause.
Time frame: Up to 60 months
dDFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): distant recurrence, or second primary invasive cancer.
Time frame: Up to 60 months
RFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): invasive local, regional, or distant recurrence.
Time frame: First dose date up to 38 months plus 30 days
Time frame: First dose date up to 38 months plus 30 days
Time frame: Up to 60 months
TTW of FACT-B TOI scores will be analyzed for each index, the TTW of FACT-B scores will be measured from the randomization date and to the time the participants first experienced a first score of worsening.
Interested in participating?
Request InfoGilead Sciences
Industry
A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy
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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