CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 110 target
Drug / intervention
Sacituzumab Govitecan +1 moredrug
Likely dose
Not stated in record
Key inclusion· 14
  • ✓Histologically or cytologically confirmed invasive breast cancer with unresectable locally advanced or metastatic disease
  • ✓ER and PR expression both ≤5% by IHC, HER2-negative by ASCO/CAP guidelines
  • ✓PD-L1-negative: IC <1% (SP142) or CPS <10 (22C3)
  • ✓Treatment-naïve in metastatic setting
Key exclusion· 14
  • ✕Prior systemic anti-cancer therapy within 4 weeks of study initiation (except bisphosphonates and RANK inhibitors)
  • ✕Prior anti-PD-1, PD-L1, or PD-L2 agents
  • ✕Prior sacituzumab govitecan (IMMU-132) or any irinotecan/topoisomerase I-containing antibody drug conjugates
  • ✕Prior hypersensitivity to pembrolizumab, its excipients, or sacituzumab govitecan

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04468061
NCT04468061Phase 2RecruitingOn TrackUpdated 2mo ago
Long Recruiting
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Saci-IO TNBC: Randomized Phase II Study of Sacituzumab Govitecan With or Without Pembrolizumab in PD-L1-negative Metastatic Triple Negative Breast Cancer (TNBC)

Dana-Farber Cancer Institute·interventional·Posted Jul 13, 2020·Updated Apr 29, 2026

In Brief

A Phase 2 clinical trial evaluating Sacituzumab Govitecan and Pembrolizumab for Breast Cancer and 2 related conditions. Currently recruiting, targeting 110 participants across 15 sites.

Detailed Summary

This research study involves testing the safety and efficacy of an investigational intervention for patients with triple-negative breast cancer (TNBC) that has spread, or metastasized, to other parts the body and is PD-L1-negative. The names of the study interventions involved in this study are: * Sacituzumab govitecan (Trodelvy™;IMMU-132) * Pembrolizumab (Keytruda®; MK-3475)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Triple Negative Breast Cancer, PD-L1 Negative
CountriesUnited States
CollaboratorsGilead Sciences, Merck Sharp & Dohme LLC

Timeline

Phase 2Recruiting
202120222023202420252026202720282029
First PostedJul 13, 2020
Enrollment StartJul 20, 2020
Primary CompletionApr 1, 2027
Study CompletionApr 1, 2029
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 6.0 years agoPrimary completion in 9 months

Interventions

Sacituzumab Govitecandrug

Intravenous Infusion

Pembrolizumabdrug

Intravenous Infusion