General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT06103864

Background Information

This is a Phase III, randomised, open-label, 3-arm, multicentre, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with investigator's choice chemotherapy in combination with pembrolizumab in participants with PD-L1 positive locally recurrent inoperable or metastatic TNBC.

For more information, visit: https://clinicaltrials.gov/study/NCT06103864

Offered At

Inova Schar Cancer Institute
A division of Inova Fairfax Hospital
8081 Innovation Park Drive 
Fairfax, VA 22031

3600 Joseph Siewick Dr.  
Fairfax, VA 22033

 
Principal Investigator

Angela Pennisi, MD

Eligibility Information

  • Histologically or cytologically documented locally recurrent inoperable, which cannot be treated with curative intent, or metastatic TNBC, as defined by the ASCO-CAP guidelines.
  • PD-L1 positive TNBC based on results from an appropriately validated investigational PD-L1 (22C3) assay (CPS ≥ 10) from a sponsor designated central laboratory.
  • No prior chemotherapy or other systemic anti-cancer therapy for metastatic or locally recurrent inoperable breast cancer.
    • Patients with recurrent disease will be eligible if they have completed treatment for Stage I-III breast cancer, if indicated, and ≥6 months have elapsed between completion of treatment with curative intent and the first documented recurrence.
  • Eligible for one of the chemotherapy options listed as ICC (paclitaxel, nab-paclitaxel, or gemcitabine + carboplatin)
  • Adequate bone marrow reserve and organ function.
  • Male and female participants of childbearing potential must agree to use protocol-specified method(s) of contraception.
  • Additional eligibility in protocol

Ineligibility Information

  • History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before Cycle 1 Day 1 and of low potential risk for recurrence.
  • Uncontrolled infection requiring IV antibiotics, antivirals or antifungals.
  • Active or uncontrolled hepatitis B or C virus infection.
  • Known HIV infection that is not well controlled.
  • Uncontrolled or significant cardiac disease.
  • Severe pulmonary function compromise.
  • Clinically significant corneal disease.
  • Active or prior documented autoimmune or inflammatory disorders.
  • Additional ineligibility in protocol