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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
EU CTIS ID: 2024-511646-40-00
What this study is testing
Part 1: To assess the safety and tolerability profile of durvalumab + novel oncology therapies with or without paclitaxel and durvalumab + paclitaxel. Part 2: To assess the efficacy of durvalumab + novel oncology therapies with or without paclitaxel in terms of ORR.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
- Korea, Republic of
- Canada
- Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States; Korea, Republic of; Canada; Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.