CARBOPLATIN for Breast cancer|HER2-negative breast cancer

Inclusion criteria

• {"criterion_text":"-Histologically or cytologically confirmed, HER2-negative, men or women with breast adenocarcinoma with radiologic measureable disease (>20 mm) and Ki67 labeling index ≥ 20% in patients with T2 tumor and ≥ 15% in patients with T3 or T4 tumors.\n-WHO performance status ≤ 2\n-Adequate hematological function : Absolute neutrophil count (ANC) ≥1.0 x 109/L and Platelet count ≥100 x 109/L and Hemoglobin ≥10 g/dL (may be transfused to maintain or exceed this level)\n-Adequate liver function: Total bilirubin <1.5 x upper limit of normal (ULN) and AST, ALT <2.5 x ULN (in cohort I) and AST, ALT <5 x ULN (in cohort II)\n-Adequate renal function: Serum creatinine ≤1.25 x ULN (and if measured: Creatinine clearance within normal reference values)."}

Exclusion criteria

• {"criterion_text":"-Previous chemotherapy treatment for localized breast cancer less than 24 months before inclusion into study (cohort I) or metastatic breast cancer treated with taxane (cohort II).\n-Other earlier or concomitant carcinoma less than five years prior to the breast cancer diagnosis, except for BCC, in situ cervix cancer or breast cancer.\n-Treatment with any other investigational agent, or participation in another clinical intervention trial within 21 days prior to enrolment."}

Primary endpoints

• {"endpoint_text":"-The genomic tumor architecture as described by CAAI, and tumor cell heterogeneity before and after treatment as detected and verified by DNA analysis (SNP analysis/sequencing) and quantified by the six CARMA indices.","definition_or_measurement_approach":"Measured by DNA analysis (SNP analysis/sequencing) and quantified using the six CARMA indices; described as genomic (DNA) state and changes over time in tumors."}

Secondary endpoints

• {"endpoint_text":"-The overall change in the expression (the number and the magnitude of change) of mRNA, and protein in the different treatment groups across timepoints.","definition_or_measurement_approach":"Measured by mRNA and protein expression analyses across timepoints (e.g., RNA microarray analyses or RNA sequencing; protein tissue arrays/protein arrays/protein kinase activity)."}
• {"endpoint_text":"-Changes in the metabolite distribution (individual metabolites and magnitude) as measured by HR-MAS in the different treatment groups.","definition_or_measurement_approach":"Measured by High resolution MR magnetic angle spinning (HR-MAS) analyses of metabolite distribution."}
• {"endpoint_text":"-Treatment induced changes and characteristics in circulating tumor DNA and circulating tumor cells in peripheral blood compared to tumor response","definition_or_measurement_approach":"Analysis of circulating tumor-DNA in plasma and circulating tumor cells (CTC) in peripheral blood at tumor sampling time points, compared with tumor analysis and by treatment arm."}
• {"endpoint_text":"-Difference in levels of fatigue between treatment arms.","definition_or_measurement_approach":"Assessment of fatigue course during treatment across regimens; specific instruments not specified in provided data."}
• {"endpoint_text":"-Host-related, tumor-related and treatment-related factors predicting chronic fatigue","definition_or_measurement_approach":"Analysis of predictors of chronic fatigue based on host, tumor and treatment-related factors; specific measures not detailed in provided data."}

Norway

Earliest CTIS Part Ii Submission Date

02-09-2024

Latest Decision Or Authorization Date

17-12-2025

Processing Time Days

471

Number Of Sites

1

Number Of Participants

260

Primary sponsor

Full Name

Oslo University Hospital HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway