23-BRE-57-GS (GS-US-595-6184): 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 Surge

Grants and Contracts Details

Description

23-BRE-57-GS (GS-US-595-6184): 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 Primary: To compare invasive disease-free survival (iDFS) between SG and pembrolizumab versus treatment of physician s choice (TPC) Secondary: 1. To compare overall survival (OS) between the 2 arms 2. To compare distant disease-free survival (dDFS) as assessed by investigator between the 2 arms 3. To compare recurrence-free survival (RFS) as assessed by investigator between the 2 arms 4. To compare safety and tolerability between the 2 arms 5. To compare time to worsening (TTW) quality of life (QoL) outcomes as measured by Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B) between the 2 arms Exploratory: 1. To assess PD-L1 expression and its correlation to clinical outcomes 2. To assess residual cancer burden (RCB) and its correlation to clinical outcomes 3. To assess the presence of TILs and its correlation to clinical outcomes 4. To assess tumor expression of Trop-2 as a potential predictive biomarker of response to study treatment 5. To explore blood and tumor biomarkers including circulating tumor DNA (ctDNA) that may be associated with response to study treatment
StatusActive
Effective start/end date1/30/241/30/26

Funding

  • Alliance Foundation Trials LLC: $3,500.00

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