EPIRUBICIN HYDROCHLORIDE for Breast cancer

Inclusion criteria

• {"criterion_text":"- Female patients aged ≥ 18 years."}
• {"criterion_text":"- Treated with any, or a combination, of the drugs cyclophosphamide, epirubicin, doxorubicin, docetaxel and paclitaxel."}
• {"criterion_text":"- Written informed consent."}

Exclusion criteria

• {"criterion_text":"- Patients fulfilling any of the contraindications mentioned for the studied drugs."}
• {"criterion_text":"- Patients treated with a combinatorial regime of docetaxel, carboplatin and trastuzumab."}
• {"criterion_text":"- Patients receiving palliative chemotherapy."}
• {"criterion_text":"- Patients included in other clinical studies receiving not approved investigational medicinal drug."}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is to measure the incidence of grade 1-2 anemia (as defined by CTC v.4) in two exposure groups; high and low, in patients treated with EPI and CPA.","definition_or_measurement_approach":"Incidence of grade 1-2 anemia as defined by CTC v.4, compared between two exposure (AUC) groups (high vs low) in patients treated with epirubicin (EPI) and cyclophosphamide (CPA)."}

Secondary endpoints

• {"endpoint_text":"- What correlations can be identified between exposure (AUC) and; hematologic-, liver-, cardiac- and ovarian toxicity?","definition_or_measurement_approach":""}
• {"endpoint_text":"- What correlations can be identified between exposure (AUC) and the patients’ quality of life?","definition_or_measurement_approach":""}
• {"endpoint_text":"- To what extent can genetic predispositions for drug metabolism be used to identify patients at increased risk of under- or overdose?","definition_or_measurement_approach":""}
• {"endpoint_text":"- What correlations can be identified between exposure (AUC) and tumor response in patients receiving neo-adjuvant treatment?","definition_or_measurement_approach":""}
• {"endpoint_text":"- What correlations can be identified between; BMI, age, smoking habits and renal status vs. exposure (AUC)?","definition_or_measurement_approach":""}
• {"endpoint_text":"- Can we identify any relationship between drug exposure (AUC) and; medical care needs, level of employment and time for recovery?","definition_or_measurement_approach":""}
• {"endpoint_text":"- Is there a difference in total and recurrence-free survival, between patients with low compared to medium or high exposure (AUC)?","definition_or_measurement_approach":""}
• {"endpoint_text":"- Is there a difference in the prevalence of severe adverse events in patients’ with high compared to low exposure (AUC)?","definition_or_measurement_approach":""}
• {"endpoint_text":"- Is the dose measurement in capillary blood samples equal or comparable to venous blood samples?","definition_or_measurement_approach":""}
• {"endpoint_text":"- What correlations between exposure (AUC) and circulating extracellular vesicles can be identified?","definition_or_measurement_approach":""}
• {"endpoint_text":"- What correlations between exposure (AUC) and health state utility values can be identified?","definition_or_measurement_approach":""}
• {"endpoint_text":"- Is there a difference in health care costs associated with severe adverse events in patients exhibiting high exposure compared to those with low exposure (AUC)?","definition_or_measurement_approach":""}
• {"endpoint_text":"- Capillary self-sampling success and sample quality rate.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Usability and acceptability of microsampling devices based on patient feedback: Usability Questionnaire.","definition_or_measurement_approach":""}

Sweden

Earliest CTIS Part Ii Submission Date

06-08-2024

Latest Decision Or Authorization Date

02-04-2026

Processing Time Days

604

Number Of Sites

1

Number Of Participants

200

Primary sponsor

Full Name

Karolinska Institutet

Organisation Type

Educational Institution

Country Of Registered Address

Sweden