Management of Severe Chemotherapy-induced Neutropenia in Advanced Breast Cancer (NCT03104595) | Clinical Trial Compass
CompletedPhase 1/2
Management of Severe Chemotherapy-induced Neutropenia in Advanced Breast Cancer
South Korea28 participantsStarted 2017-10-30
Plain-language summary
To assess the safety and establish the dose to assess the pharmacokinetic activity following administration of EC-18 in patients with advanced breast cancer receiving low febrile neutropenia risk chemotherapy who are the candidates for second-line or higher combination therapy with doxorubicin and cyclophosphamide.
Who can participate
Age range19 Years
SexFEMALE
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Inclusion criteria
✓. Women ≥19 years of age
✓. Subjects who have voluntarily signed the informed consent prior to the screening tests to participate in the study
✓. Subjects who have been diagnosed as adenocarcinoma of the breast and relapsed after adjuvant or primary (neoadjuvant) chemotherapy, and was confirmed based on documented medical history to be candidates for second-line or higher combination chemotherapy with doxorubicin and cyclophosphamide to treat relapsed or metastatic disease.
✓. Subjects with adequate function of major organs based on the following clinical laboratory values in the latest test performed within 28 days prior to IP dosing:
✓. Subjects whose Eastern Cooperative Oncology Group (ECOG) performance score is 0-1.
✓. For women of child bearing potential, subjects should have willingness to use acceptable contraceptive methods during the entire clinical study period.
✓. Subjects who are capable of understanding the overall procedure of the clinical study and are willing to participate in compliance with all test procedures.
Exclusion criteria
✕. Subjects with active and inactive hepatitis, patients with history of HIV, or other uncontrolled infectious disease.
✕. Subjects with a history of HIV positive or currently undergoing/received antiretroviral therapy, and subjects with a history of hepatitis B surface antigen positive, or current positive hepatitis C disease.
. Subjects who received radiation therapy within 4 weeks prior to assignment to treatment group.
✕. Subjects who have been diagnosed within 5 years with other types of cancer except for those who have been appropriately treated for superficial non-melanoma skin cancer or cervical intraepithelial neoplasia.
✕. Subjects with a history of intolerance for granulocyte colony stimulating factor treatment
✕. Subjects who are expected to show hypersensitivity to the IP or its ingredients
✕. Subjects with a positive urine pregnancy test result at screening visit or before the first administration of the study drug
✕. Subjects who took any other investigational product in other clinical study within 30 days prior to screening visit.