General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT06112379

Background Information

Full Title: A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) + Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab + Chemotherapy 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; TROPION-Breast04)

This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer.

For more information, please visit https://clinicaltrials.gov/study/NCT06112379.

Offered At

Inova Schar Cancer
8081 Innovation Park Drive
Fairfax, VA 22031

Inova Fair Oaks Hospital
3600 Joseph Siewick Drive
Fairfax, VA 22033
Principal Investigator

Angela Pennisi, MD

Eligibility Information

  • Participant must be ≥ 18 years, at the time of signing the ICF
  • Histologically confirmed Stage II or III unilateral or bilateral primary invasive TNBC or hormone receptor-low/HER2-negative breast cancer
  • Provision of acceptable tumor sample
  • Adequate bone marrow reserve and organ function
  • Additional eligibility in protocol

Ineligibility Information

  • History of any prior invasive breast malignancy
  • Active or prior documented autoimmune or inflammatory disorders
  • Clinically significant corneal disease
  • Uncontrolled infection requiring i.v. antibiotics, antivirals or antifungals; suspected infections; or inability to rule out infections
  • Uncontrolled or significant cardiac disease
  • History of non-infectious ILD/pneumonitis
  • Severely compromised pulmonary function
  • Additional ineligibility in protocol