Klinische Studie

Abemaciclib in Combination with Endocrine Therapy as First Line Therapy in Advanced or Metastatic Breast Cancer Patients with Symptomatic Visceral Metastases or High Tumor Burden (Abemacare)(ABEMACARE)Abemaciclib in Kombination mit endokriner Therapie bei fortgeschrittenen oder metastasiertem Brustkrebs (Phase IV, Open Label, Single Arm, Multicenter Study)
Krankheitsentität(en) Brust
StudientypInterventionsstudiePhase IV
Wesentliche EinschlusskriterienMale or female. If female: pre-menopausal women provided they are being treated with a LHRH analogue for at least 28 days or post-menopausal women as defined by any of the following criteria: i Age ≥60 year ii. Age <60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and/or FSH level within the laboratory’s reference range for postmenopausal females; iii. Documented bilateral oophorectomy. If male: patient must have started concomitant treatment with a LHRH analogue Life expectancy greater or equal to 12 weeks Histologically proven diagnosed advanced or metastatic breast cancer not amenable to curative treatment
Wesentliche AusschlusskriterienPatients who are currently receiving or have previously received firstline therapy (endocrine or chemotherapy) for locoregionally recurrent or metastatic breast cancer. have received prior treatment with any CDK4/6 inhibitor (or participated in any CDK4/6 inhibitor clinical trial for which treatment assignment is still blinded) have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of randomization for a nonmyelosuppressive or myelosuppressive agent, respectively
Ansprechpartner & KontaktCaritas-Krankenhaus St. Josef RegensburgFrauenheilkunde und Geburtshilfe Krankenhaus St JosefStudienzentrale0941 7823403fhk-studienzentrum(at)csj.de