OLECLUMAB for Metastatic triple negative breast cancer

Inclusion criteria

• {"criterion_text":"- Female"}
• {"criterion_text":"- At least 18 years of age at the time of screening"}
• {"criterion_text":"- Patient must have locally confirmed advanced/unresectable or metastatic TNBC"}
• {"criterion_text":"- No prior treatment for metastatic (Stage IV) TNBC"}
• {"criterion_text":"- Patient must have at least 1 lesion, not previously irradiated, that can be accurately measured"}
• {"criterion_text":"- WHO/ECOG status at 0 or 1 at enrollment"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Patients enrolled in Arm 8 (durvalumab + Dato-DXd): Must have PD-L1 positive tumor as determined by an IHC based assay"}

Exclusion criteria

• {"criterion_text":"- History of allogeneic organ transplantation"}
• {"criterion_text":"- Patients enrolled in Arm 2 only: Diagnosis of diabetes mellitus Type I or diabetes mellitus Type II requiring insulin treatment"}
• {"criterion_text":"- Patients enrolled in Arm 5 only: History of venous thromboembolism in the past 3 months"}
• {"criterion_text":"- Patients enrolled in Arm 7 and Arm 8 only: Clinically significant corneal disease in the opinion of the Investigator."}
• {"criterion_text":"- Patients enrolled in Arm 6, 7 and 8 only: History of or active interstitial lung disease/pneumonitis"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Patients enrolled in Arm 6 only: Previously been diagnosed as HER2+ or received HER2-targeted therapy"}
• {"criterion_text":"- Active or prior documented autoimmune or inflammatory disorders"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- Untreated CNS metastases"}
• {"criterion_text":"- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients"}
• {"criterion_text":"- Any concurrent chemotherapy, IP, or biologic therapy for cancer treatment"}
• {"criterion_text":"- Female patients who are pregnant, breastfeeding"}
• {"criterion_text":"- Cardiac Ejection Fraction less than 50%"}
• {"criterion_text":"- 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)"}

Primary endpoints

• {"endpoint_text":"- Part 1: AEs, exposure, physical examinations, laboratory findings, and vital signs","definition_or_measurement_approach":"Safety and tolerability assessments including adverse events (AEs), exposure, physical examinations, laboratory findings, and vital signs as reported in Part 1."}
• {"endpoint_text":"- Part 2: Endpoints based on Investigator assessment according to RECIST 1.1: ORR (objective response rate): The percentage of evaluable patients with a confirmed Investigator-assessed visit response of CR (complete response) or PR (partial response).","definition_or_measurement_approach":"ORR defined per RECIST 1.1 as percentage of evaluable patients with confirmed Investigator-assessed CR or PR."}

Secondary endpoints

• {"endpoint_text":"- Part 1: Endpoints based on Investigator assessment according to RECIST 1.1: ORR (objective response rate): The percentage of evaluable patients with a confirmed Investigator-assessed visit response of CR (complete response) or PR (partial response)","definition_or_measurement_approach":"ORR as per RECIST 1.1; percentage of evaluable patients with confirmed CR or PR."}
• {"endpoint_text":"- Part 1: Endpoints based on Investigator assessment according to RECIST 1.1: PFS (progression-free survival): Time from date of first dose until the date of objective radiological disease progression using RECIST 1.1 or death (by any cause in the absence of progression","definition_or_measurement_approach":"PFS measured from first dose date to objective radiological progression per RECIST 1.1 or death."}
• {"endpoint_text":"- Part 1: Endpoints based on Investigator assessment according to RECIST 1.1: DoR (duration of response): Time from date of first detection of objective response (which is subsequently confirmed) until the date of objective radiological disease progression","definition_or_measurement_approach":"DoR measured from first detection of objective response (confirmed) until objective radiological progression."}
• {"endpoint_text":"- Part 1: Endpoints based on Investigator assessment according to RECIST 1.1: OS (overall survival): Time from date of first dose until the date of death by any cause","definition_or_measurement_approach":"OS measured from date of first dose until death from any cause."}
• {"endpoint_text":"- Part 1: Serum concentration of durvalumab and serum or plasma concentration of novel oncology therapies","definition_or_measurement_approach":"Pharmacokinetic measurement of serum or plasma concentrations of durvalumab and applicable novel therapies."}
• {"endpoint_text":"- Part 1: Presence of ADAs for durvalumab and applicable novel oncology therapies","definition_or_measurement_approach":"Assessment of anti-drug antibodies (ADAs) for durvalumab and applicable novel therapies."}
• {"endpoint_text":"- Part 2: Endpoints based on Investigator assessment according to RECIST 1.1: PFS (progression-free survival): Time from date of first dose until the date of objective radiological disease progression using RECIST 1.1 or death (by any cause in the absence of progression)","definition_or_measurement_approach":"PFS measured per RECIST 1.1 from first dose to progression or death."}
• {"endpoint_text":"- Part 2: Endpoints based on Investigator assessment according to RECIST 1.1: DoR (duration of response): Time from date of first detection of objective response (which is subsequently confirmed) until the date of objective radiological disease progression","definition_or_measurement_approach":"DoR measured from first confirmed objective response until radiological progression."}
• {"endpoint_text":"- Part 2: Endpoints based on Investigator assessment according to RECIST 1.1: PFS6: PFS at 6 months following date of first dose","definition_or_measurement_approach":"PFS6 defined as progression-free survival status at 6 months after first dose."}
• {"endpoint_text":"- Part 2: Endpoints based on Investigator assessment according to RECIST 1.1: OS (overall survival): Time from date of first dose until the date of death by any cause","definition_or_measurement_approach":"OS measured from first dose to death from any cause."}
• {"endpoint_text":"- Part 2: AEs, exposure, physical examinations, laboratory findings, and vital signs","definition_or_measurement_approach":"Safety and tolerability assessments including AEs, exposure, physical examinations, laboratory findings, and vital signs in Part 2."}

Poland

Earliest CTIS Part Ii Submission Date

22-07-2024

Latest Decision Or Authorization Date

19-05-2025

Processing Time Days

301

Number Of Sites

6

Number Of Participants

61

Primary sponsor

Full Name

AstraZeneca AB

Organisation Type

Pharmaceutical company

Country Of Registered Address

Sweden

Contract research organisations

Name

Parexel International (IRL) Limited

Responsibilities

sponsorDuties codes: 1,12,5,8; contact Clinicaltrial.Enquiries@parexel.com; phone 0035314729500

Third parties

• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"sponsorDuties codes: 1,12,5,8; contact Clinicaltrial.Enquiries@parexel.com","organisation_type":"Pharmaceutical company"}