A Phase IB/II Study to determine efficacy and safety of Durvalumab + Paclitaxel and Durvalumab in Combination with Novel Oncology Therapies with or without Paclitaxel for First-line Metastatic Triple Negative Breast Cancer
- Conditions
- First-line (1L) Stage IV Triple Negative Breast Cancer (TNBC) - the subtype of breast cancer characterized by a lack of tumor expression of estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2.MedDRA version: 20.0Level: PTClassification code: 10075566Term: Triple negative breast cancer Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2024-511646-40-00
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 320
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, Patients enrolled to Arm 6 (durvalumab and DS-8201a): Must provide documentation of locally determined advanced/unresectable or metastatic TNBC with HER2 low tumor expression (IHC 2+/ISH–, IHC 1+/ISH–, or IHC 1+/ISH untested, Patients enrolled in Arm 8 (durvalumab + Dato-DXd): Must have PD-L1 positive tumor as determined by an IHC based assay
History of allogeneic organ transplantation, Patients enrolled in Arm 2 only: Diagnosis of diabetes mellitus Type I or diabetes mellitus Type II requiring insulin treatment, Patients enrolled in Arm 5 only: History of venous thromboembolism in the past 3 months, Patients enrolled in Arm 7 and Arm 8 only: Clinically significant corneal disease in the opinion of the Investigator., Patients enrolled in Arm 6, 7 and 8 only: History of or active interstitial lung disease/pneumonitis, Patients enrolled in Arm 6, 7 and 8 only: Use of chloroquine or hydroxychloroquine in <14 days prior to Day 1 of DS-8201a (Arm 6) or Dato-DXd (Arm 7 and Arm 8) treatment, Patients enrolled in Arm 6 only: Previously been diagnosed as HER2+ or received HER2-targeted therapy, 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, Cardiac Ejection Fraction less than 50%, Patients enrolled in Arm 2 only: Potent inhibitors or inducers or substrates of CYP3A4 or substrates of CYP2C9 or CYP2D6 within 2 weeks before the first dose of study treatment (3 weeks for St John’s Wort)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method