It is expected to generate consistent evidence that it is not inferior in terms of objective response rate
The University Assistance Complex of León (Caule) participates in the ‘Abigail’ international clinical trial, promoted by the oncology research company ‘Medsir’, which will compare the efficacy of the drug abemaciclib in combination with endocrine therapy, against a short cycle of chemotherapy as first-line treatment in patients with locally advanced and inoperable or metastatic breast cancer with criteria for aggressive disease.
Through Abigail, a total of 160 patients will be randomized 1:1 to treatment arm A, receiving abemaciclib with endocrine therapy, or arm B, receiving three cycles of chemotherapy with paclitaxel. Once the chemotherapy cycles are completed and according to the investigator’s criteria, the patient could start treatment with abemaciclib plus endocrine therapy or continue with the paclitaxel regimen.
Assess efficacy at twelve weeks
The main objective of this trial is to evaluate the efficacy, measured by the objective response rate at twelve weeks, of abemaciclib in combination with endocrine therapy versus paclitaxel in this type of patient.
«The samples of primary tumor and metastatic lesions will be collected before the start of treatment in both arms, as well as blood samples at 15 days and in progression. With these samples, different parameters will be analyzed, such as the presence of mutations or genetic variations to try to associate the results of the clinical study with different markers”, explains the main researcher of the oncology department at Caule, Ana López.
The rest of the León Hospital research team is made up of Mariana López as an oncologist sub-investigator, Laura López from the Diagnostic Radiology Service, Emiliano Honrado from the Pathological Anatomy Service, Susana Abella as an Oncology nurse and several representatives from the Pharmacy Service.
Development in hospitals of different countries
They all hope that this study will provide consistent evidence that the combination of abemaciclib with endocrine therapy as a first-line regimen is not inferior to the optimal first-line with chemotherapy, consisting of weekly paclitaxel, in terms of objective response rate after first twelve weeks of treatment in patients with metastatic breast cancer or with poor prognosis.
‘Abigail’ is an international study, currently in the patient recruitment phase, which is being carried out in a total of 26 hospitals in Spain, France, Portugal and Italy under the scientific direction of Dr. Antonio Llombart and will be carried out at the Althaia Hospital by the researcher Clara Martínez.