Rak piersi: badanie fazy III leku durvalumab i paclitaxel

Kryteria wyłączenia kto nie może wziąć udziału (15)

1. As judged by investigator, any evidence of diseases (such as severe or uncontrolled medical conditions including systemic diseases, uncontrolled hypertension, serious gastrointestinal conditions associated with diarrhoea, chronic diverticulitis or previous complicated diverticulitis, history of allogeneic organ transplant, and active bleeding diseases, ongoing and active infection, significant cardiac conditions, substance abuse, psychiatric illness/social situation or psychological conditions) which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.
2. History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 2 years before Cycle 1 Day 1 and of low potential risk for recurrence.
3. Participants with a history of previously treated neoplastic spinal cord compression or treated, clinically inactive brain metastases that are no longer symptomatic, who require no treatment with corticosteroids or anticonvulsants, may be included in the study if they have recovered from acute toxic effects of radiotherapy. - Participants with treated clinically inactive brain metastases that are no longer symptomatic, who require no treatment with corticosteroids or anticonvulsants, may be included in the study if they have recovered from acute toxic effects of radiotherapy.
4. Uncontrolled infection requiring IV antibiotics, antivirals or antifungals.
5. Active or uncontrolled hepatitis B or C virus infection.
6. Known HIV infection that is not well controlled.
7. Uncontrolled or significant cardiac disease.
8. History of non-infectious ILD/pneumonitis (including radiation pneumonitis) that required steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
9. Clinically severe pulmonary function compromise.
10. Clinically significant corneal disease.
11. Active or prior documented autoimmune or inflammatory disorders.
12. Prior exposure to any treatment including ADC containing a chemotherapeutic agent targeting topoisomerase I and TROP2-targeted therapy.
13. Any concurrent anti-cancer treatment.
14. Participants with a known severe hypersensitivity to PD-1/PD-L1 inhibitors or Dato-DXd.
15. Currently pregnant (confirmed with positive pregnancy test), breastfeeding or planning to become pregnant.