ABemaciclib, ET ± paclItaxel in aGgressive HR+/HER2- MBC trIaL (NCT04603183) | Clinical Trial Compass
CompletedPhase 2
ABemaciclib, ET ± paclItaxel in aGgressive HR+/HER2- MBC trIaL
Italy, Portugal162 participantsStarted 2021-06-02
Plain-language summary
This is a multicenter, randomized, 2 arm, open label, phase II study. It is designed to compare the efficacy and safety of abemaciclib combined with ET (letrozole or fulvestrant) versus a short course with induction chemotherapy with paclitaxel followed by maintenance therapy with abemaciclib combined with ET (letrozole or fulvestrant) in patients with previously untreated, unresectable locally advanced, or metastatic HR positive/HER2 negative breast cancer with aggressive disease criteria.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Signed informed consent form (ICF) prior to participation in any study-related activities.
✓. Male or female patients ≥18 years at the time of signing the ICF.
✓. Eastern Cooperative Oncology Group performance status of 0 or 1.
✓. Life expectancy of at least 24 weeks.
✓. Pre-menopausal, peri-menopausal, and post-menopausal women as defined by any of the following criteria:
✓. Documented bilateral oophorectomy;
✓. Age ≥60 years;
✓. Age \<60 years and cessation of regular menses for ≥12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and/or FSH level within the laboratory's reference range for post-menopausal females.
Exclusion criteria
✕. Known hypersensitivity to abemaciclib, letrozole, fulvestrant, paclitaxel, and/or any of their excipients.
✕. Are currently receiving an investigational drug in a clinical study or participating in any other type of medical research judged not to be scientifically or medically compatible with this study.
✕. Formal contraindication to ET defined as visceral crisis and rapidly or symptomatic progressive visceral disease.
✕. Known concurrent malignancy or malignancy within 5 years of study enrollment except for carcinoma in situ of the cervix, non-melanoma skin carcinoma, or stage I uterine cancer. For other cancers considered to have a low risk of recurrence, discussion with the medical monitor is required.
✕. Known active brain metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable for ≥4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable, and without requirement of steroid treatment for ≥14 days prior to first dose of study treatment.
✕. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
✕. Major surgical procedure within 14 days prior to treatment initiation or anticipation of the need for a major surgical procedure during the course of the study other than for diagnosis.
✕. Active bleeding diathesis venous thrombo-embolism, previous history of bleeding diathesis, or chronic anti-coagulation treatment, or any indications or history of Disseminated Intravascular Coagulation (DIC) or Deep vein thrombosis (DVT).