Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients with TNBC Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05)
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
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Clinical Trial Information
Trial Contact: Durand, Jennifer; Ribacchi, Stephanie; Casillas, Bridey L
Trial Phone: 321.843.2026 ; 321-841-1077 ; 321.841.8284
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IRB No: SSU00221265
Protocol Abbrev: GS-US-595-6184
Principal Investigator: Nikita Chandrakant Shah, MD
Phase: Drug: Phase III
Age Group: Adult
Secondary Protocol No: ASCENT-05
Treatment: Biological: Sacituzumab Govitecan-hziy (SG) Biological: Pembrolizumab Drug: Capecitabine
ClinicalTrials.gov ID: NCT05633654
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Objective
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.
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Key Eligibility
Key Inclusion Criteria:
• Age > 18 years, with residual invasive triple negative breast cancer (TNBC) in the breast or lymph nodes after neoadjuvant therapy and surgery:
o TNBC criteria for the study is defined as estrogen receptor (ER) and progesterone receptor (PR) < 10%, human epidermal growth factor receptor 2 (HER2)-negative per American Society of Clinical Oncology and College of American Pathologists (ASCO/CAP) guidelines (IHC and/or ISH).
• Adequate excision and surgical removal of all clinically evident of disease in the breast and/or lymph nodes and have adequately recovered from surgery.
• Submission of both pre-neoadjuvant treatment diagnostic biopsy and resected residual invasive disease tissue.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• Individuals must have received appropriate radiotherapy and have recovered prior to starting study treatment.
• Adequate organ function.
