The ABIGAIL study is expected to generate evidence that the combination of abemaciclib with endocrine therapy as first-line treatment is not inferior to chemotherapy treatment in terms of objective response rate.
This new clinical trial, supported by MEDSIR, an independent research company in oncology, will compare the efficacy of abemaciclib in combination with endocrine therapy (letrozole or fulvestrant), with a short course of chemotherapy as first-line treatment in patients with endocrine receptors (HR) positive breast cancer that is negative for the HER2 protein, and is either locally advanced and inoperable or metastatic with aggressive disease criteria.
Dr. Antonio Llombart, Head of the Oncology Dept.
at the Arnau de Vilanova University Hospital
Abemaciclib, a cyclin-dependent kinase (CDK) inhibitor drug, is indicated for the treatment of patients with these subtypes of breast cancer. These types of drugs block the activity of two proteins, CDK4 and CDK6, which help control cell division.
In this trial, called ABIGAIL, a total of 160 patients will be randomized 1:1 to treatment in either arm A, receiving abemaciclib with endocrine therapy, or to arm B, receiving 3 cycles (12 weeks) of chemotherapy with paclitaxel. At the end of the chemotherapy cycles, and at the discretion of the investigator, the patient could start treatment with abemaciclib plus endocrine therapy or continue with the paclitaxel regimen.
The main objective of this trial is to evaluate the efficacy which will be measured by the objective response rate at 12 weeks of abemaciclib in combination with endocrine therapy versus paclitaxel in these types of patients.
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. The samples will be analyzed for different parameters such as the presence of mutations or genetic variations, in order to try to associate the results of the clinical study these different markers.
“We hope that this study provides consistent evidence that the combination of abemaciclib with endocrine therapy as a first-line regimen is not inferior to the optimal first-line chemotherapy, which consists of weekly paclitaxel, in terms of objective response rate after the first 12 weeks of treatment in patients with HR-positive and HER2-negative metastatic breast cancer with a poor prognosis ”, explains Dr. Antonio Llombart, head of the oncology department at the Arnau de Vilanova University Hospital.
According to a recent subgroup analysis of patients using data from the MONARCH 2 and MONARCH 3 phase III clinical trials, patients with aggressive disease and poor prognostic characteristics (in terms of presence of liver metastases, progesterone receptor (PgR) -negative, high-grade tumors or short treatment-free interval) had the greatest benefit from adding abemaciclib to endocrine therapy. These data suggest that patients with more aggressive disease and a lower tumor-endocrine-sensitive profile could derive considerable benefit from this combination in the setting of advanced disease.
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.
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