USO 22297

A Phase III, Open-Label, Randomized Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Cheomotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients with Previously Untreated Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer (D926QC00001)

Disease Types: Breast Cancer Research

Eligibility Requirements:

• Males and females with histologically confirmed Stage II or III primary invasive TNBC or HR-low/HER2- BC

• T1c, N1 to N2; T2, N0 to N2; T3, N0 to N2; T4a-d, N0 to N2

• ER IHC <1% or 1 to <10%, PR IHC <1% or 1 to <10%

• Neither hormone receptor may be ≥10% • HER2 IHC 0 or 1+, or 2+ with no ISH amplification

• Must provide FFPE tumor sample within 12 weeks prior to randomization

• No prior therapy for TNBC or HR-low/HER2- BC allowed incl surgery, radiotherapy, or systemic anticancer therapy 

Available at:

• Chesapeake
• Newport News (Port Warwick III)
• Norfolk (Brock Cancer Center)
• Virginia Beach (Princess Anne)
• Williamsburg