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 cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-000764-29-GB
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 191
1. Female
2. At least 18 years of age at the time of screening
3. Patient must have locally confirmed advanced/unresectable or metastatic TNBC
4. No prior treatment for metastatic (Stage IV) TNBC
5. Patient must have at least 1 lesion, not previously irradiated, that can
be accurately measured
6. 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)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. History of venous thromboembolism in the past 3 months
2. Diagnosis of diabetes mellitus Type I or diabetes mellitus Type II requiring insulin treatment
3. History of allogeneic organ transplantation
4. Active or prior documented autoimmune or inflammatory disorders
5. 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)
6. Untreated CNS metastases
7. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients
8. Any concurrent chemotherapy, IP, or biologic therapy for cancer treatment
9. Female patients who are pregnant, breastfeeding
10. Cardiac Ejection Fraction less than 50%
Patients enrolled to Arm 6 (durvalumab and DS-8201a)
1. History of or active interstitial lung disease/pneumonitis
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