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
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
Statusrekrutierend
Ansprechpartner & KontaktCaritas-Krankenhaus St. Josef RegensburgFrauenheilkunde und Geburtshilfe Krankenhaus St JosefStudienzentrale0941 7823403fhk-studienzentrum(at)csj.de