At a glance
ClinicalIndex Comparison RecordPhase 2Active· 110 enrolled
Drug / intervention
Pembrolizumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Saci-IO HR+: Randomized Phase II Study of Sacituzumab Govitecan With or Without Pembrolizumab in Hormone Receptor-positive (HR+) / HER2- Metastatic Breast Cancer (MBC)
In Brief
A Phase 2 clinical trial evaluating Pembrolizumab and Sacituzumab Govitecan for Invasive Breast Cancer and 3 related conditions. Active but no longer recruiting, targeting 110 participants across 8 sites.
Detailed Summary
This research study is evaluating the safety and effectiveness of Sacituzumab Govitecan with or without Pembrolizumab in metastatic HR+/HER2- breast cancer. The names of the study interventions involved in this study are: * Sacituzumab govitecan (IMMU-132) * Pembrolizumab (Keytruda®; MK-3475)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInvasive Breast Cancer, Metastatic Breast Cancer, HR-Positive Breast Cancer, HER2-negative Breast Cancer
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC, Gilead Sciences
Timeline
Phase 2Active
2021202220232024202520262027
First PostedJun 2020
Enrollment StartSep 2020
Primary CompletionMar 2024
TodayJul 2026
Study CompletionJun 2027
First PostedJun 26, 2020
Enrollment StartSep 23, 2020
Primary CompletionMar 9, 2024
Study CompletionJun 1, 2027
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 6.0 years ago
Interventions
Pembrolizumabdrug
(iv) fixed dose, administered once per cycle
Sacituzumab Govitecandrug
(iv) fixed dose, administered twice per cycle