A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer (NCT03742102) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer
United States243 participantsStarted 2018-12-21
Plain-language summary
This study is designed to determine the efficacy and safety of durvalumab in combination with novel oncology therapies with or without paclitaxel and durvalumab + paclitaxel for first-line metastatic triple negative breast cancer
Who can participate
Age range18 Years – 130 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Female
✓. At least 18 years of age at the time of screening
✓. Patient must have locally confirmed advanced/unresectable or metastatic TNBC.
✓. No prior treatment for metastatic (Stage IV) TNBC
✓. Patient must have at least 1 lesion, not previously irradiated, that can be accurately measured
✓. WHO/ECOG status at 0 or 1 at enrollment
Exclusion criteria
✕. History of allogeneic organ transplantation
✕. Active or prior documented autoimmune or inflammatory disorders
✕. Active infection including tuberculosis, hepatitis B (known positive HBV surface antigen \[HBsAg\] result), hepatitis C virus (HCV), or human immunodeficiency virus (positive HIV 1/2 antibodies)
✕. Untreated CNS metastases
✕. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients
✕. Any concurrent chemotherapy, IP, or biologic therapy for cancer treatment
✕. Female patients who are pregnant, breastfeeding
✕
What they're measuring
1
Dose Limiting Toxicity (DLT) Events
Timeframe: From the time of first dose until completion of the first cycle (28 days for Arms 2-5, 21 days for Arms 6-7 (no safety run-in for Arms 1 and 8))